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2019 / Vol.8/ Issue-1
www.insightscare.com
The
BEST
MEDICAL
CLINICAL
LABORATORIES
&
To Watch For 2019
Tech-
advancements
Gearing the
Future of
Laboratories
ince many decades, medical devices have been growing smaller, inexpensive, and more portable. The point-of-
Scare tests that are tested external to the traditional laboratory are extensively used for monitoring blood glucose
in diabetes, pregnancy testing, and for many other applications.
Today, medical testing is experiencing another altering phase where recent technological advances are enabling the
development of tests that make medical screening, diagnosis, and monitoring less confined, more low-cost, and
patient-focused. Few of these devices are next-generation point-of-care devices while others provide individuals with
unprecedented genetic information.
New and emerging medical tests have the potential to deliver the kind of patient-centered as well as evidence-based
medicine that consumers and healthcare professionals have been expecting. One of those examples can be the
situation for the people having diabetes. Pricking their fingers to draw blood and then test the blood in a glucose
monitoring machine can be a tedious process. Sometimes it means that diabetics don’t test their glucose as frequent as
they should. Plus, the method doesn’t provide the big picture of how an individual’s glucose levels change throughout
the day and night. However, continuous glucose monitoring (CGM) offers a solution for substituting the finger prick
method and these systems rely on a small sensor placed under the skin and a data receiver. Further progresses
showcases that concept a step further by providing efficient CGM that is compatible with a smart watch. A prime
benefit of the device is that people can track their glucose data and this is how parents can make a precise record of
their loved ones health from far.
Truly, this is an exciting time for medical testing, but there are various considerations for these evolving technologies.
Also, data privacy is a primary concern as consumers and their healthcare providers become more flooded in personal
medical information.
New testing devices are best used along with professional consultation to ensure you aren’t making decisions that
could compromise their health. Advanced testing technologies are still complimentary to traditional laboratory testing.
While many of the tests are in their early days, they promises us of moving closer to a complete individualized, less
confined, and patient-centric medicine.
Ashwini S. Deshpande, Editor
ealth is one of the major concerns in a person’s life. A person rushes to the hospital or a
Hclinic when there is any kind of health issue and he is assured that he will be treated there
and will return home healthy. But, a doctor cannot give confirmation of what a patient is
suffering through, unless he gets the clinical reports of the specimens of the patients. Hence, medical
and clinical laboratories play a vital role in accurately diagnosing a disease the patient is suffering
from.
With the advancements in technology, new methodologies and high-end types of equipment are
emerging that are aiding for better and error-free diagnosis. This has impacted the healthcare industry
like never before. Various companies are now using this as an opportunity for the betterment of the
people. In this edition of “The 10 Best Medical & Clinical Laboratories to watch for 2019” we
are showcasing the companies that have paved their way innovation through uniqueness.
TM
In this issue of Insightscare, we have featured Aspenti Health , a diagnostic and digital health
company designed to address population health for substance use management; Diamond Medical
Laboratory, a prominent laboratory that delivers high quality and cost-effective care through its
highly trained professional staff; DNAfit, a renowned customized health and wellness company using
genetic science to improve health outlook for millions of people; San Diego Reference Laboratory
(SDRL), a full service, client-focused analytical biomedical testing laboratory that delivers
comprehensive clinical and drug testing toxicology services; Covance; Northeast Laboratory
Services; MedLabs; PGD Labs; Proficiency Healthcare Diagnostics; and Serosep Diagnostic.
Additionally, we have also highlighted the story of SCL Healthcare Central Laboratory in an
exclusive interview with its CEO, Kyoung Ryul Lee. We have also incorporated an interesting
article from our in-house editor.
So, flip the pages and enjoy a good read!
The Backbone of
the Healthcare
Industry
MEDICAL & CLINICAL
LABORATORIES
TO WATCH FOR 2019
1Best
T
H
E
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August, 2019
Editor-in-Chief Pooja M. Bansal
Executive Editor Aishwarya Nawandhar
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Art & Design Assistant Poonam Mahajan
Visualiser David King
Managing Editor Ashwini S. Deshpande
Art & Picture Editor Shweta Ambilwade
Co-designer Paul Belin
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Sales Executives Amy, John, Bill, Sarah
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Technical Consultants David, Robert
Technical Head Jacob Smile
Copyright © 2019 Insights Success, All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in
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Reprint rights remain solely with Insights Success.
Senior Editor Anish Miller
Marry D'SouzaMarketing Manager
Mark williamsBusiness Development Executive
Assistant Technical Head Pratiksha Patil
Assistant Digital Marketing Manager Prashant Chevale
SME-SMO Executives Manoj, Gemson, Uma
Research Analyst Eric Smith
Circulation Manager Tanaji
Interview with insights success
Article
Industry Trends
Recent Advancements in
Diagnostic Industry
SCL Healthcare Central
Laboratory
10
16
The Forefront of Research and
Clinical Trial Studies in Korea
Aspenti Health ™
Offering Diagnostic and
Digital Health Solutions for
Substance Use and Pain
Management
DNAt
Personalizing Wellness with
Cutting-edge DNA Tests
San Diego Reference
Laboratory
Committed to Better
Living through Chemistry
20
Diamond Medical
Laboratory
Providing Unmatched
Mobile Healthcare Services
24
28
32
SCL Healthcare
Central Laboratory
Healthcare is moving from
volume-based care to value-
based and with it, we can
expect the clinical standards to rise and
improve quality of life. Research and
development of various medicines,
therapeutics, and methodologies are
not only taking us closer to achieving
new milestones in healthcare, but also
in revamping the efficiency and
reliability of already existing
techniques. A leading Korean
company, that has been instrumental in
carrying out research and development
for various healthcare providers is SCL
Healthcare Central Laboratory
(SHC C-LAB).
With three core values- Service,
Quality and Research, SHC C-LAB
has developed into the largest
nationwide clinical laboratory and has
acquired the reputation of best
reference laboratory in Korea. SCL
Healthcare Group is led by its CEO,
Kyoung Ryul Lee, M.D., Ph.D. To
understand more about the laboratory,
its services, its journey through all
these years, we bring to you an
exclusive interview with Mr. Lee. He
discusses, in detail, about the company,
their future plans, and various other
interesting aspects of the SHC C-LAB
and the industry.
1. Kindly share in brief about SCL
Healthcare Central Laboratory.
Also, tell us about your vision and
mission.
SCL Healthcare Central Laboratory
(SHC C-LAB) is the Korea’s first
central Laboratory dedicated to
clinical studies.
We started central Laboratory
business since 2006 as the first and
largest central laboratory in Korea.
We have been dedicating and
carrying out our works in
developing new drugs and clinical
trials (phase I, II, III, IV),
Investigator Initiated Trials (IIT),
Sponsor Initiated Trials (SIT), and
experiments for research papers.
Our experts on clinical trials and
experiments help researchers in all
process from consultation to result
reporting.
We promote healthcare that will
continue onto future generation by
harmonizing the physical, mental
and environmental states through
consideration and respect
The Forefront of Research and Clinical Trial Studies in Korea
10 / August 2019 /
Kyoung Ryul Lee
M.D., Ph.D, CEO
/ August 2019 / 11
2. Tell us something about the
CEO/Founder/Director/MD of the
laboratory.
A CEO of SCL Healthcare Group,
Kyoung Ryul Lee M.D., Ph.D is a
medical doctor specialized in
Laboratory Medicine. He graduated
Yonsei University College of
Medicine. He was a professor at
Yonsei University. He became a
CEO of SCL Healthcare Group in
2007.
He emphasizes to maintain our three
key values which are quality,
service and R&D. He received the
“Order of the Polar Star” from
Mongolian government for the first
time in field of medicine in 2009,
because SCL Healthcare Group
founded MOBIO diagnostic
Medical Laboratory in Ulan Bator,
Mongolia. He also received Global
Leader Award from Global
Community in 2017. He highlight
that the SCL Healthcare Group will
double our efforts to satisfy our
clients, therefore we will be
dedicated to becoming a truly
patient-centered Central Laboratory
that focuses on evidence-based
medicine.
3. What influenced you to start a
healthcare laboratory? Share
with us your journey so far.
As the advancement in new drugs
development progresses more
globally, the importance of a central
laboratory business is being
increasingly emphasized in Korea as
it is in the United States and Europe.
In order to meet these growing
demands, SCL Healthcare, a pioneer
in clinical diagnostics, established
the Korea’s first central laboratory.
4. What was the turning point for
SCL Healthcare Central
Laboratory, according to you?
As clinical trials have increased and
customer’s needs have been
diversified, I founded SCL
Healthcare in 2010 by separating
from SCL (Seoul Clinical
Laboratories). In addition to the
Central Laboratory, we have
expanded our business to the
Companion Bio-marker Center,
Medical Diagnosis, and Bio
Logistics. Since then, our clients
have high satisfaction and we have
currently the highest market share
in the domestic Central Laboratory
field. Through both quantitative and
qualitative improvements, SHC C-
LAB will grow into a key global
company.
5. What are the unique
points/specialties of the
laboratory?
Tests performed in SHC C-LAB
maintain continuity using validated
methods. Test results are generally
kept in storage until the application
for new drug approval and for a
longer period of time as requested
by our customers.
Since the process of developing new
drugs takes long, it is usually
desired that the same index is used
during a clinical study. In order to
meet the strict demands, we perform
tests continuously with the same
validated-test methods.
By unifying reference ranges and
eliminating deviations that may
occur during the analysis of each
site, we produces test results that are
more easily interpreted and have
continuity.
In addition, SHC C-LAB reports
test results with a data management
process specialized for clinical
studies and that allows fast and
convenient bio-statistical analysis.
6. Apart from technology and
applications, what are the other
services and solutions that your
lab provides?
SHC C-LAB puts unsurpassed
resources, knowledge and
experience in laboratory
management to work for customers
on each clinical study.
We provide experienced project
management staff to support the
high test level of quality.
• National and international
communications
• Clinical study knowledge resources
• Risk management focus with a
customer service
• Support for kits
• Remnant specimen storage
• Study data management
• Quality assurance
7. How advanced are your lab
equipment?
SCL Healthcare has state-of-the art
equipment including the largest
Laboratory Automation System
(LAS) in Asia. We have optimal
environment for central laboratory
testing such as automatic
ventilation, automatic temperature
and humidity control system for all
kinds of esoteric test items.
8. What critical measures do you
take to ensure the safety of your
employees in the lab?
All employees wear a gown, gloves,
and a mask when tests are
performed and we have safety
equipment such as eye wash station
and emergency shower station.
We also conduct safety management
training once a month.
9. Being the key person of the
company, one of the main
responsibilities is to ensure that
the needs of the clients are being
met properly. How do you co-
ordinate with your team
members to guarantee client
satisfaction?
SCL Healthcare pursues field
12 / August 2019 /
management, speed management, and
quality management as its management
policy.
In order to perform accurate test
quickly and correctly, employees
have ample opportunity and
complete the necessary training.
The company respects all
employees and is committed to
maintaining a good and safe
working environment.
In addition, in order to
communicate with clients, staff
members regularly visit clients and
we develop and provide various
tests for the diagnosis and research
of diseases through professional
academic activities.
10. Share with us the most
spectacular client experiences?
When we attended an international
conference, one of the biggest
CROs (Clinical Research
Organizations) visited our booth
and had a meeting. The company
was interested in expanding its
business in Asia including Korea,
and was an opportunity to
introduce our company and talk
about possible areas for
cooperation. The CRO’s
executives then visited our
laboratory in Korea, toured the
facilities, and discussed specific
partnerships.
Currently, we are working
collaboratively in many parts of
domestic and overseas clinical
trials, and SHC C-LAB are
participating in the field of new
drug development with pride as
Korea’s representative Central
Laboratory.
11. What are the awards and
accolades your company has
received so far?
Certifications:
• Acquired CAP (College of
American Pathologists)
Certification in 1998 as Korea’s
first Laboratory participated in
CAP
• Certified NGSP (National
Glycohemoglobin Standardization
Program) Level 1 Laboratory every
year
• Received ISBER (International
Society for Biological and
Environmental Repositories, USA)
• Acquired QMEQAS (CTQ/INSPQ
external quality assessment
scheme)
• Acquired CDC LSP (Centers for
Disease Control and Prevention for
Lipid Standardization Program)
• Acquired CDC Newborn (Centers
for Disease Control and Prevention
for Newborn Screening and
Molecular Biology)
• Acquired CDC LAMP (Centers for
Disease Control and Prevention for
Lead and MultiElement
Proficiency)
• Received CDC VDSCLP (CDC
Vitamin D Standardization-
Certification Program) as Asia first
laboratory in 2015
• Received G-EQUAS (German
External Quality Assessment
Scheme)
• Received ISO9001 quality
management certification in
Clinical Laboratory
• Acquired GCLP (Good Clinical
Laboratory Practice) in 2019
12. What are your future goals?
Also, tell us about the ongoing or
upcoming projects your
company could launch.
Our long-term vision is to leap
forward as a “Global Medical
Company”. We plan to implement
the strategy step by step such as
establishing new business
processes and expanding our
global market share. With new
paradigm of the medical
environment in time of needs,
SHC C-LAB will continue to
present new business models for
customer satisfaction and patient-
centered healthcare.
13. What advice would you give to
the budding entrepreneurs in
the industry?
As clinical trials market is
expanding and become more
complex, the role of the central
laboratory is becoming
increasingly important.
Only laboratories those are well
aware of the trends of trials and
can work with customer’s needs
will be able to grow into a key
player in the clinical trial market.
• 2017 Global Leader Award
from Global Community
• 2015 Grand Prize in Medical
Asia 2015
• 2015 Ministry of Health
and Welfare Award
• 2014 Mongolia Ulaanbaatar
Railway Service Medal
• 2012 Seoul Mayor Award
• 2011 Mongolian Ministry of
Health, Mongolian Medical
Pioneer Medal
• 2009 Mongolian President,
Arctic Medal
• 2009 American Biographical
Institute, Top 500 Influential
People in the World
• 2009 Korea Minister of Health,
Welfare and Family Award
• 2007 Stevie Award Iba Chief
Executive Officer Finalist
AWARDS
Interview with Insights care
/ August 2019 / 13
16 / August 2019 /
he healthcare sector is moving from reactive care to preventive care. Preventive
Tcare helps the patient take necessary precautions to avoid certain conditions and
also helps them in identifying the root of a disease before it becomes serious.
Additionally, the cost of preventive care is much less than that of reactive care.
Diagnostics is a major part of preventive care. All the conventional treatment methods
mostly follow the trial and error method, where the illness is guessed based on the
symptoms the patient shows. It is necessary to move ahead from this method to
personalized care to improve the outcomes of healthcare. Optimum diagnosis is the first
step towards this. The diagnostics industry is witnessing immense transformation and
there are various new developments that are helping it move towards personalized care.
Let'slookattherecentdevicestransformingdiagnostics.
Ebola is a highly contagious and deadly virus and
once infected, it leaves limited treatment options
forthepatient.Moreover,itcanspreadeasilyand
startanepidemic.Tocombatthedangersitbrings
to the human lives, scientists at the Rochester
Institute of Technology (RIT) have developed the
prototype of a novel micro device. This device
helps diagnose the infection caused by Ebola
early,whichresultsinbettertreatmentoutcomes
aswellasreducesthespreadofinfections.
The developed microfluid device has biosensors
attached to it. It is a small, automated chip that
has fluorescence sensors attached to it. The
device detects the Ebola RNA when the patient's
sample is added to it by activating the CRISPR
mechanism.Theresearchersarefurthertryingto
find a way to generate this device at affordable
costs.
Better Detection of
Ebola Virus with a
Microfluid Device
Industry Trends
/ August 2019 / 17
KidneyIntelX is the main diagnostic test for
kidney diseases devised by Renalytix AI plc. It
exhibits promise to improve the clinical
management of patients with fast-growing
kidney diseases and type-2 diabetes. It helps in
better diagnosis and well as treatment of these.
KidneyIntelX uses machine learning algorithms
to examine the combination of predictive blood-
based biomarkers. These include sTNFR1,
sTNFR2, and KIM1 along with the electronic
health record data. The device is designed to
identify the progressive kidney disease. It was
designatedasaBreakthroughDevicebyFDA.
KidneyIntelX-
A Breakthrough
Device
KidneyIntelX is the main diagnostic test for
kidney diseases devised by Renalytix AI plc. It
exhibits promise to improve the clinical
management of patients with fast-growing
kidney diseases and type-2 diabetes. It helps in
better diagnosis and well as treatment of these.
KidneyIntelX uses machine learning algorithms
to examine the combination of predictive blood-
based biomarkers. These include sTNFR1,
sTNFR2, and KIM1 along with the electronic
health record data. The device is designed to
identify the progressive kidney disease. It was
designatedasaBreakthroughDevicebyFDA.
Q-POC –
A Revolutionary
Diagnostics Kit
18 / August 2019 /
MinION, a new DNA sequencing device by
Oxford Nanopore, can detect the Huntington's
disease a lot faster than the traditional ways. It
could therefore drastically reduce the waiting
time for number of critical cases of Huntington's
disease, as well as other genetic disorders in the
future.Moreover,itmeetsthestrictinternational
qualitystandardsforlaboratoryuse.
MinION is a small device which decodes every
DNA strand separately in real-time. This hand-
held device can then identify the changes in any
DNA sequence to detect the genetic disorder.
Being able to do all of this in real-time, the device
cutsdownthewaittimefortheresults.
A Remarkable
DNA Sequencing
Device- MinION
MinION, a new DNA sequencing device by
Oxford Nanopore, can detect the Huntington's
disease a lot faster than the traditional ways. It
could therefore drastically reduce the waiting
time for number of critical cases of Huntington's
disease, as well as other genetic disorders in the
future.Moreover,itmeetsthestrictinternational
qualitystandardsforlaboratoryuse.
MinION is a small device which decodes every
DNA strand separately in real-time. This hand-
held device can then identify the changes in any
DNA sequence to detect the genetic disorder.
Being able to do all of this in real-time, the device
cutsdownthewaittimefortheresults.
Mass Spec-
Promise of a
Better Tomorrow
The medical diagnostics industry is advancing at a fast-paced. The new innovations come with a
promise to enhance the accuracy of detecting diseases in a human body in real-time. Moreover, the
easeofuse,simplicityinmanufacturingaswellastheaffordabilityofthelatestdevicesisimproved.
-Aishwarya
/ August 2019 / 19
Offering Diagnostic and Digital Health Solutions for
Substance Use and Pain Management
spenti Health was established
Aby a group of seasoned
healthcare leaders who made a
commitment to acquire a struggling
toxicology lab in Burlington Vermont,
three years ago. From the initial days,
their vision was to leverage crucial lab
data and supplement this vital
information in addiction and care
recovery with value services including
software, health analytics, and leading-
edge education. This paradigm shift for
a lab, fueled by the opioid crisis and
the broader impact that substance use
disorder has on communities, families
and personal friends, motivated them
to innovate continuously and act
differently than any other toxicology
lab.
Aspenti Health ™ is the first lab
designed to address population health
for substance use and pain
management patient through diagnostic
and digital health solutions.
The Dedicated Duo
Aspenti’s CEO, Chris Powell, is a
dynamic personality who has over 30
years of enriched experience in
healthcare. He started his career with
IBM as field sales professional before
moving to IDX Systems Corporation,
which was acquired by GE Healthcare
in 2006. There, Chris worked as the
Vice President and General Manager of
GE Healthcare Americas Commercial
Healthcare IT business, including the
United States, Canada, and Central and
South America. Chris left GE in 2011
and went on to become CEO at
Precyse, a Health Information
management (HIM) company that led
the healthcare transition to the ICD-10
coding set. Under Chris’ leadership and
growth, Precyse was acquired to form
nThrive, a healthcare revenue cycle
and service company, before coming to
Aspenti Health.
Jill Warrington MD, PhD, is the
Chief Medical Officer of the company
has more than two decades of
experience in the medical field with a
focus on laboratory medicine and
substance use care. She is passionate
about the role that laboratories can play
in optimizing clinical decision making
and supporting clinical workflows. Her
key areas of interest include driving
appropriate utilization of testing
services, integrating health analytics to
inform care, and reducing
administrative burden through
automatization of unnecessary
operational steps.
Distinctive Services and Solutions
Aspenti Health is a unique healthcare
company in the substance use disorder
(SUD) space. Being specifically
designed to promote population health
for substance use and pain
management patients, Aspenti is a
state-of the art laboratory that
leverages innovative methods for urine
drug screening and confirmation
testing with wrap-around technology
and services. The company is changing
the standard of care for SUD patients
through Care Coordination,
Population-specific Health Analytics,
and Education.
Aspenti’s Care Coordination tool,
Aspenti Navigator a random testing
engine schedules and
notifies patients for random tested
based on the frequency assigned. The
company’s software solution alleviates
the administrative strain of managing
random testing. Aspenti Insights,
powered by its advanced business
analytics software and data analysts
provides real time health analytics to
help control costs and improve
outcomes.
Identifying the ability of population
health analytics to support community
partners and directly impact patient
care, Aspenti has an internal health
analytics team and a versatile custom
business analytic tool. Using
laboratory data, it has deep insights on
emerging drug trends, treatment
adherence, and the frequency of
unexpected findings. Aspenti leverages
Aspenti Health ™
20 / August 2019 /
strategic partnerships to gain insights
into social determinants of health and
align those with emerging drug trends
in a meaningful way to deliver the
most impactful data.
Two of its unique analytics offerings
are Patient Population Metrics Report,
a quarterly report for providers
presenting insights into ordering
patterns and emerging drug trends.
Another offering is Geospatial
Mapping, which is designed to give
visibility to community partners on
county-level drug use demonstrating
marked variability in buprenorphine
adherence as well as in fentanyl and
heroin use.
Aspenti IQ: A Trailblazing
e-Learning Facility
Aspenti Health’s innovative eLearning
offering, Aspenti IQ, leverages the
superlative digital learning
functionality with its unique subject
matter expertise. It delivers CME/CNE
accredited courses in clinical best
practice, protocol, compliance, patient
communication, and many more
mission-critical subject areas. Of all
the tools available to drive better care
and prevent addiction before it starts,
education is the company’s most
powerful factor that transcends the
entire spectrum of care touching not
only patients and providers, but also
families and friends. All Aspenti IQ
courses are mobile-friendly and
CME/CNE accredited. Each represents
modern learning theory by utilizing
micro-learning, scenarios-based
concepts and video.
Aspenti was chosen as a national
partner by HealthStream, the largest
Healthcare learning management
platform in the country, reaching more
than 4,000 healthcare organizations
and hosting 4.8 million users. Aspenti
will be deploying education to the front
lines of care, reinforcing the quality
and impact of Aspenti’s eLearning
solutions with content such as
“Responsible Opioid Care and Pain
Management Certification”. It is a 16
course micro-certification track
featuring the subject matter such as
foundations, compliance, opioid
misuse, and pain management.
Outstanding Client Experience
Aspenti strives hard to maintain loyalty
Chris Powell, CEO
MEDICAL & CLINICAL
LABORATORIES
TO WATCH FOR 2019
1
Best
T
H
E
Our vision is to
create a world
where we
enrich every life
through
diagnostic science
and compassionate
care. Together
we can end the
human suffering
and costs
associated
with substance
use disorder
‘‘
‘‘
/ August 2019 / 21
and satisfy its customers at every level.
While talking about the same, the
company shares one of its memorable
client experiences.
“The strength of the partnership
between Aspenti Health and the
University of Vermont Health Network
(UVMHN) lies in the alignment of our
goals to improve people’s lives. Aspenti
Health’s approach is broader than just
performing drug testing, by asking
what it really takes on a population
level to reduce the impact of substance
use disorder on people’s lives. The
UVMHN Department of Pathology and
Laboratory Medicine is working
closely with Aspenti Health, sharing
the expertise each of brings to solve
this national crisis in new ways; using
the UVMHN as a place to pilot
innovative solutions with new testing
methods, education for providers,
patients and families, and data
analytics to clarify barriers to
individuals’success. This is a novel
addition to Vermont’s already
successful hub and spoke model of care
for substance use disorder.”- Debra
Leonard, MD, PHD Chair, Pathology
and Laboratory Medicine at University
of Vermont Medical Center
Abiding Core Values
Integrity is one of four core values of
Aspenti along with innovation,
inspiration, and inclusion. The
company believes that it is the
foundation of the quality and
compliance programs that shapes the
company. The role of integrity in the
company’s operations enters into every
aspect of the business model right from
conducting its specimen collections
and process testing for its patients and
providers, to ensuring sound financial
processes and compliance standards
and interacting within organization and
clients.
Apart from its core values, Aspenti
considers the safety of its colleagues as
a critical factor. Along with meeting
the standards of key regulatory bodies
including the New York State
Department of Health, CLIA, and the
College of American Pathologists
(CAP), the company also invites state
and local regulatory organizations to
voluntarily inspect its lab. Also, in
direct patient interactions, the company
has well-trained its colleagues on
aggression de-escalation and trauma-
informed care to support a safe, non-
confrontational environment.
Advanced and Secured Lab
Equipment
Aspenti has a state-of-the lab art
laboratory designed with a LEAN,
linear workflow and reliant upon
sophisticated Liquid Chromatography-
Tandem Mass Spectrometry (LC-
MS/MS) technology. This technology
has been cited as a future of laboratory
chemistries and requires highly
specialized technical expertise to
perform. The team of Aspenti has
learned from related-disciplines of
environmental toxicology, sports
medicine, and forensic toxicology to
build this focused clinical laboratory.
Jill Warrington, CMO
22 / August 2019 /
DiamondMedical Laboratory
Providing Unmatched Mobile Healthcare Services
Andrew Diamond
CEO
24 / August 2019 /
market leader spearheading with its unique
Aapproach and methodology in the medical space
is Diamond Medical Laboratory. The lab
delivers high quality, appropriate, and cost-effective care
through its diverse, energetic, and highly trained
professional staff. The prime goal of the laboratory is to
ensure that customers and patients are serviced in a
compassionate and ethical manner in an effort to
continuously expand its presence in nursing homes,
assisted livings and the homes of seniors.
DML works closely with various providers that serve the
same population with the goal of keeping their patients
healthier and most importantly, keeping them out of the
hospital.
Why DML?
The DML is an expert in providing quality living,
nursing homes, and individual homes for seniors to
provide services at their location. It provides a
phlebotomist and serves the patients in their “Homes”.
The lab currently processes over 90% of the specimens
in its lab in Owings Mills, MD. Besides, DML is a
partner with other local laboratories to run testing to
benefit the patients.
DML’s owners and office staff are always available to
assist its clients. It offers customized services that meet
the clients’ unique needs. The laboratory is committed to
personal service where one can have the comfort of
speaking to a familiar voice every time they call. The
team at DML gives equal importance to the commitment
for the serving community. DML and its owners donate
to many local charities and organizations as a way to
give back to the community.
Safety and Customer Satisfaction at its Highest
Priority
On the safety front, SOP’s have been approved by
DML’s Medical Director and Lab Manager assuring that
the lab complies with all state and medical regulations.
The lab also provides OSHA training and regular safety
trainings to make sure its staff is always using proper
measures to stay safe in the lab.
The management staff of DML coordinates through a
collaboration portal to resolve client issues permanently
and in a timely manner. They also send quarterly reports
to the company’s clients containing the information
about the test performed, the number of patients they
have seen, along with the number of critical results they
“Our goal is to ensure customers and
patients are serviced in a compassionate and
ethical manner to continuously expand our
presence in nursing homes, assisted livings,
and the homes of seniors
MEDICAL & CLINICAL
LABORATORIES
TO WATCH FOR 2019
1
Best
T
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”
/ August 2019 / 25
have come across. The team also attends their quarterly
meetings to exchange information and resolve problems
related to client satisfaction. “We take client satisfactions
very seriously. I provide my cell phone number to all
clients as a way to expedite a resolution. We review all
client concerns monthly and ensure that the time frame
we respond in is as timely as possible,” says Andrew.
The Vibrant Trio at the Laboratory
The Founder of Diamond Medical Laboratory is
Andrew Diamond. He received an undergraduate
degree in Criminology from the University of Maryland
College Park. After graduation, Andrew managed a
branch of a Nationwide Mortgage Company for 5 years.
He eventually sold the business to his partners and
created Marvel Title and Escrow. In 2014, he purchased
ownership in Mobile Medical Imaging, a portable
imaging company and increased the revenue by
over 400% in just the span of 2 years. Andrew
was approached by a representative from a skilled
nursing facility about opening a medical
laboratory to serve their residents in October
2016. That is when the decision to open Diamond
Medical Laboratories was made.
Mike Kluttz, the CEO of DML is a graduate of
UMBC with an undergraduate degree in business
management and biology. He has over 35 years of
experience with various laboratories and for last
24 years he has been in a management position.
Mike has been the acting CEO of the clinical
laboratory for approximately 4 years.
Another important persona at DML is David
Robinson, the Chief Laboratory Officer of the
lab. He is an army veteran having 27 years of
enriching experience in clinical and research
laboratories. He has handled diverse positions in
the field, right from Phlebotomist to Laboratory
Supervisor and even as a Clinical Research
Coordinator. He has also worked in small
laboratories, field hospitals, and even large
medical centre laboratories. For the past 4 years,
he has worked as the Laboratory Service Manager
at DML.
Future Goals
Diamond Medical Laboratory wishes to serve 100
skilled nursing facilities along with 30 assisted
livings and 100 home bound patients a day. The
laboratory will be putting together an antibiotic or
anti-microbial stewardship program to assist its
Skilled Nursing Facilities in compliance with
Federal mandates. Besides, it is also looking
forward to initiating more molecular testing to
provide its clients with faster results, which would
avoid re-administer to the hospital.
26 / August 2019 /
n award-winning and renowned market leader
Athat has a big vision for UK healthcare is DNAfit,
part of the Prenetics Group. The company is
eager to put power in people’s hands to take charge of
their health using their bodies as the best source of
intelligence. DNAfit is helping people reach their wellness
goals faster, as well as playing its role in reducing pressure
on the NHS.
In 2018, DNAfit were acquired by Prenetics, giving it a
depth into the range of available genetic tests. Prenetics is
a leading genetic testing and digital health company
headquartered in Hong Kong and London and has offices
in 10 countries globally. Prenetics owns laboratories,
conduct and publish their scientific research. It has over
US $50m in strategic investments from Alibaba and Ping
An, making them one of the fastest-growing genetic
testing and digital health groups globally.
Later this year, DNAfit has plans to get behind various
preventive diseases that can help people make
preventative lifestyle changes.
Why DNAfit?
DNAfit has a mission to use genetics to transform the
health and wellness outlook for millions of people. The
DNAfitPersonalizing Wellness
with Cutting-edge DNA Tests
Avi Lasarow
Founder & CEO
28 / August 2019 /
company strives to reduce and prevent lifestyle-related
health conditions, making everyone live longer,
healthier, and happier lives. It has a vision to not only
make people aware of what their bodies need to be
healthy, but also to motivate them to be proactive in
making positive changes to benefit their health.
DNAfit has published the world’s first genetically guided
exercise intervention study, alongside many other studies
looking at gene x environment interaction. Its products
provide a lab report along with the personal one to one
health coaching, online exercise, and meal planning
platforms and at-home blood testing.
The Influential Leader
Avi Lasarow, the Founder and CEO of DNAfit has
dedicated over a quarter of his life in the relentless
pursuit of science and technological innovation. He is
driven to pioneer and humanize science that was
unreachable, unexplainable and unaffordable for so long,
His sheer commitment to making DNA results more
accessible has meant that thousands of people across the
world can live happier & healthier.
The Inception Story
Having worked in the life sciences industry for several
years, Lasarow was much aware of the life-changing
potential of health technology, but it was his personal
experience that made him realize the important role of
personalization in getting people to make healthier
choices.
After selling his previous company, Lasarow started to
focus on getting fit and healthy. At that point, he began
looking at the role that genetics plays in how we respond
to different kinds of exercise and nutrition. Lasarow
noticed that, although genetics was becoming
increasingly popular for ancestry, nobody was concerned
with using their genetic profile to inform their health and
wellbeing choices. He saw this as an opportunity to help
people put their genetic data into action and began
applying this personalized approach to his own nutrition
and workouts. Achieving great results and seeing the
amazing impact genetic insight can have led Lasarow to
create DNAfit as a way to help others reach their health
goals.
Assuring Safety and Quality with Cutting-edge
Technology
DNAfit uses advanced technologies in all of its
laboratories and uses small targeted PCR analysis,
custom Illumina SNP array analysis and Whole Exome
Sequencing for all parts of its services.
The company applies gold-standard Agile project
management methodologies across its whole business
and client communications following Prince2 & PMP
protocols. Also, each client of DNAfit is assigned a
‘partner implementation manager’, who liaises directly
with the client. The partner implementation manager
looks after their needs and timelines are communicated
accordingly. This provides a single, consolidated voice to
the client, along with providing the power of the wider
team to move quickly and deliver a quality service.
We're Eager To Put More Power In People’s Hands
To Take Charge Of Their Health, Using
The Best Possible Source Of Intelligence- Their Bodies
‘‘
‘‘
MEDICAL & CLINICAL
LABORATORIES
TO WATCH FOR 2019
1
Best
T
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/ August 2019 / 29
Salient Client Experience
DNAfit has been working immaculately to provide its clients with innovative services and its happy
customers bring the same reflection with their valuable feedbacks. One of its clients shares the
experience and delivers-
“If you genuinely care about your health and well-being, this is for you!
I signed up for this through my company’s perks and I am so glad! The results of the DNA test was very
much on par with my personal medical history and experience. I have found the resources available to
you invaluable and I use the fitness portal and also created some meal plans. The consultation with the
sports scientist was spot on, comprehensive and yet broken down to basics to help you understand your
report. The whole experience has created a real buzz in the office and boosted overall morale on my
pod.” - Sheila Bynoe Cert CII (Health and Protection), Client Relationship Manager at Chase de Vere
Independent Financial Advisers Limited (a Swiss Life company)
Awards and Accolades
In 2015, DNAfit was awarded the ‘Lloyds Bank National Business Award for Innovation’ and was
named in ‘The Fast Company’s Top 10 Most Innovative Businesses in the Data Science sectors’ which
had alongside names such as Netflix, Spotify and NASA. DNAfit were also presented with the Board of
Trade Award in audience of a UK Prime Minister. Most recently, DNAfit is honoured to have been
awarded ‘The Queen’s Award’ in two categories namely the highest official UK Awards for British
businesses, and another for the Innovation and International Trade.
30 / August 2019 /
an Diego Reference
SLaboratory (SDRL) is a full-
service, client-focused analytical
biomedical testing laboratory first
licensed in January of 1989 as a
commercial clinical laboratory. The
founding purpose of the laboratory was
to provide clinical and toxicological
laboratory services to the law
enforcement community, private
industry for pre-employment testing,
and drug treatment clinics. SDRL has
been a leader in the toxicology and
clinical laboratory testing field for over
twenty-five years and has been a
pioneer in methadone drug testing
since 1993.
The laboratory’s core mission is to
provide the highest quality of testing,
superior customer service, and
competitive pricing to a broad range of
clients throughout the United States. It
is dedicated to meeting the needs of its
customers by delivering
comprehensive clinical and drug
testing toxicology services with a
commitment to accuracy, expediency,
and accessibility.
Distinctiveness of the Lab
At SDRL, the team takes pride in the
technical expertise and assistance they
can offer clients. The team
communicates daily with their clients,
learns about new trends in the
addiction community, and continually
expands the testing menu accordingly.
They support these expanded tests with
Technical Briefs, which are
informative bulletins sent to the clients
that explain the test and its
interpretation.
In 2011, SDRL initiated writing The
Toxicology Times (toxtimes.com), a
monthly publication for clinicians and
counsellors. This monthly publication
reviews various topics surrounding the
interpretation of clinical results, drugs,
metabolism, elimination and impact on
the patients’ health. With this depth of
technical expertise, the lab is recently
certified to provide Continuing
Education Units (CEU’s) to its client’s
technical staff.
SDRL’s client service phone lines are
always answered by a live customer
executive. The lab’s senior
management, including the CEO, is
also available for more in depth and
technical explanations.
In order to maintain certain licenses
and certifications, SDRL participates in
several proficiency programs including
California Methadone Drug Analysis
Laboratory Proficiency program,
Pennsylvania Proficiency Testing, as
well as the College of American
Pathologists Forensic Drug Testing
(CAP FDT).
How was SDRL Established?
The lab was started in 1989 in response
to the change in the testing
marketplace. There was a developing
need in the opiate treatment clinics for
reliable and cost-effective toxicology
testing that was performed quickly and
accurately. The California laboratory
license requirements to provide
services to these treatment
organizations are very rigorous and
quite exacting. The license is built
around definitive drug testing
procedures and blind proficiency
testing.
With “blind” proficiency testing, the
proficiency samples are sent to the
clients of the testing laboratory. They
are then repackaged and relabelled
with pseudo patient names and
submitted to the laboratory. The
Committed to Better Living through Chemistry
32 / August 2019 /
laboratory performs the tests and
reports the results to the clinic. These
results are then sent to the regulatory
agency by the client. Proficiency
testing is done on a monthly basis with
a variable number of samples and the
laboratory must maintain a score of
90% or greater to maintain licensure.
There was also a need to offer clinical
and wellness testing to the patients in
the programs, which was not being
offered at that time. Today, SDRL
supports the physicians with functional
testing in serology, hematology, and
immunology as well as liver function
tests. This testing supports the clinical
maladies that result from drug
addiction.
Avant-garde Lab Equipment
SDRL utilizes the latest cutting-edge
laboratory technology where all
specimens are barcoded with a unique
number and are tracked throughout the
laboratory testing process with an
exact chain-of-custody. The initial
analysis of the specimen is performed
by high-speed analytical instruments
for reliable and quick identification of
various levels of substances by drug
class. At the lab, the specimens are
stored in a secure facility to make them
available for further testing. All
reporting is done same day; results are
available on the clinic’s web portal in a
secure fashion and are available for
review anytime.
Furthermore, confirmations can be
performed on abnormal results to
identify the specific analyte of the drug
class by state of the art HPLC/MS/MS
or GC/MS methodology. With its
up-to-date quality control, SDRL
makes QC results available to its
clients as further assurance of their
work.
Dr. Joseph Graas
Lab Director
MEDICAL & CLINICAL
LABORATORIES
TO WATCH FOR 2019
1
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T
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/ August 2019 / 33
With regards to safety, SDRL is a drug-free workplace and
has a strict drug testing policy and enforcement of such
requirements. All employees are trained, and follow,
Standard Operating Procedures (SOP’s) as required by each
department. The lab maintains proper training checklists for
all employees to ensure proper procedures are being
followed. In conjunction with training, they have safety
meetings with all employees, maintain a safety monitor in
each section, and provide appropriate Personal Protective
Equipment (PPE).
About the Leading Light
Dr. Joseph Graas, the founding member of SDRL, is the
Laboratory Director. Dr. Graas holds a PhD in clinical
chemistry and toxicology and has an extensive background
in the field. Having participated in laboratory operations
for nearly fifty years, he is considered as an expert in the
field of toxicology and has been retained to testify in court
in many state and federal cases. He is a member of the
American Chemical Society, American Association for
Clinical Chemistry, California Association of Toxicologists,
and a Fellow of the American Institute of Chemists and
National Academy of Clinical Biochemistry. Dr. Graas has
many technical publications and patents in the field of
Chemistry.
Bringing in Quality
The team of SDRL works with clients to solve any issues
they might experience and help explain results both
verbally and with supported documentation, such as the
Toxicology Times. They attend and present at various
conferences to learn new information in the field, have
added new testing techniques, and have expanded their test
menu to assist their clients keep up with new trends in drug
abuse.
SDRL has taken special projects for clients to help them
further understand what’s going on with their patients,
specifically pregnant females taking methadone, medication
interactions, and dosage compliance.
Happy Clients of SDRL
SDRL shares some of the memorable feedbacks from its
clients.
• “We are so pleased with our decision to change labs.
Every aspect of SDRL’s service is superior to what we
were receiving. SDRL continues to surpass our
expectations. Real people answer the phone, and
everyone is helpful and knowledgeable.”- J. F. –
Owner/Executive Director, California”
• “The level of service I receive from SDRL is unmatched
– they make me feel like I’m the only customer they
have. I would highly recommend SDRL to anyone
searching for a supportive, trustworthy and responsive
laboratory!”- D.M. – Owner, Illinois
Other Services
SDRL has implemented a 2D barcode system that allows
for efficient and error free receipt of the patient samples and
tracking throughout the testing and storage process. Its
clinical testing is geared towards the treatment of the
patients. The lab also streamlines the process from the
clinic to the laboratory and customizes services for each
client. So, it’s not a ‘one size fits all’.
Future Goals
SDRL wishes to expand the clinical laboratory testing and
to launch Therapeutic Drug Monitoring for all medications
offered by client physicians in the treatment of their
patients. The laboratory is also planning to monitor the
spread of fentanyl and fentanyl analogues in its patient
population and to expand its clinical testing menu to
include health and wellness testing. Additionally, SDRL
will continue to focus on maintaining and improving
customer care and enhancing quality management.
We Are Dedicated To Meeting The Needs Of Our
Customers By Delivering Comprehensive Clinical
And Drug Testing Toxicology Services
‘
34 / August 2019 /
The 10 best medical & clinical laboratories to watch for 2019
The 10 best medical & clinical laboratories to watch for 2019
The 10 best medical & clinical laboratories to watch for 2019
The 10 best medical & clinical laboratories to watch for 2019

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The 10 best medical & clinical laboratories to watch for 2019

  • 1. 2019 / Vol.8/ Issue-1 www.insightscare.com The BEST MEDICAL CLINICAL LABORATORIES & To Watch For 2019
  • 2.
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  • 5. ince many decades, medical devices have been growing smaller, inexpensive, and more portable. The point-of- Scare tests that are tested external to the traditional laboratory are extensively used for monitoring blood glucose in diabetes, pregnancy testing, and for many other applications. Today, medical testing is experiencing another altering phase where recent technological advances are enabling the development of tests that make medical screening, diagnosis, and monitoring less confined, more low-cost, and patient-focused. Few of these devices are next-generation point-of-care devices while others provide individuals with unprecedented genetic information. New and emerging medical tests have the potential to deliver the kind of patient-centered as well as evidence-based medicine that consumers and healthcare professionals have been expecting. One of those examples can be the situation for the people having diabetes. Pricking their fingers to draw blood and then test the blood in a glucose monitoring machine can be a tedious process. Sometimes it means that diabetics don’t test their glucose as frequent as they should. Plus, the method doesn’t provide the big picture of how an individual’s glucose levels change throughout the day and night. However, continuous glucose monitoring (CGM) offers a solution for substituting the finger prick method and these systems rely on a small sensor placed under the skin and a data receiver. Further progresses showcases that concept a step further by providing efficient CGM that is compatible with a smart watch. A prime benefit of the device is that people can track their glucose data and this is how parents can make a precise record of their loved ones health from far. Truly, this is an exciting time for medical testing, but there are various considerations for these evolving technologies. Also, data privacy is a primary concern as consumers and their healthcare providers become more flooded in personal medical information. New testing devices are best used along with professional consultation to ensure you aren’t making decisions that could compromise their health. Advanced testing technologies are still complimentary to traditional laboratory testing. While many of the tests are in their early days, they promises us of moving closer to a complete individualized, less confined, and patient-centric medicine. Ashwini S. Deshpande, Editor
  • 6. ealth is one of the major concerns in a person’s life. A person rushes to the hospital or a Hclinic when there is any kind of health issue and he is assured that he will be treated there and will return home healthy. But, a doctor cannot give confirmation of what a patient is suffering through, unless he gets the clinical reports of the specimens of the patients. Hence, medical and clinical laboratories play a vital role in accurately diagnosing a disease the patient is suffering from. With the advancements in technology, new methodologies and high-end types of equipment are emerging that are aiding for better and error-free diagnosis. This has impacted the healthcare industry like never before. Various companies are now using this as an opportunity for the betterment of the people. In this edition of “The 10 Best Medical & Clinical Laboratories to watch for 2019” we are showcasing the companies that have paved their way innovation through uniqueness. TM In this issue of Insightscare, we have featured Aspenti Health , a diagnostic and digital health company designed to address population health for substance use management; Diamond Medical Laboratory, a prominent laboratory that delivers high quality and cost-effective care through its highly trained professional staff; DNAfit, a renowned customized health and wellness company using genetic science to improve health outlook for millions of people; San Diego Reference Laboratory (SDRL), a full service, client-focused analytical biomedical testing laboratory that delivers comprehensive clinical and drug testing toxicology services; Covance; Northeast Laboratory Services; MedLabs; PGD Labs; Proficiency Healthcare Diagnostics; and Serosep Diagnostic. Additionally, we have also highlighted the story of SCL Healthcare Central Laboratory in an exclusive interview with its CEO, Kyoung Ryul Lee. We have also incorporated an interesting article from our in-house editor. So, flip the pages and enjoy a good read! The Backbone of the Healthcare Industry MEDICAL & CLINICAL LABORATORIES TO WATCH FOR 2019 1Best T H E
  • 7. Insights Success Media Tech LLC 555 Metro Place North, Suite 100, Dublin, OH 43017, United States Phone - (614)-602-1754 Email: info@insightscare.com For Subscription: www.insightscare.com Insights Success Media and Technology Pvt. Ltd. Ofce No. 22 & 510, Rainbow Plaza, Shivar Chowk, Pimple Saudagar, Pune, Maharashtra 411017 Phone - India: 7410033802, 74100058552 Email: info@insightscare.com For Subscription: www.insightscare.com sales@insightscare.com Corporate Ofces: August, 2019 Editor-in-Chief Pooja M. Bansal Executive Editor Aishwarya Nawandhar Art & Design Head Amol Kamble Art & Design Assistant Poonam Mahajan Visualiser David King Managing Editor Ashwini S. Deshpande Art & Picture Editor Shweta Ambilwade Co-designer Paul Belin Peter CollinsBusiness Development Manager Sales Executives Amy, John, Bill, Sarah Digital Marketing Manager Alina Sege Technical Consultants David, Robert Technical Head Jacob Smile Copyright © 2019 Insights Success, All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from Insights Success. Reprint rights remain solely with Insights Success. Senior Editor Anish Miller Marry D'SouzaMarketing Manager Mark williamsBusiness Development Executive Assistant Technical Head Pratiksha Patil Assistant Digital Marketing Manager Prashant Chevale SME-SMO Executives Manoj, Gemson, Uma Research Analyst Eric Smith Circulation Manager Tanaji
  • 8. Interview with insights success Article Industry Trends Recent Advancements in Diagnostic Industry SCL Healthcare Central Laboratory 10 16 The Forefront of Research and Clinical Trial Studies in Korea
  • 9. Aspenti Health ™ Offering Diagnostic and Digital Health Solutions for Substance Use and Pain Management DNAt Personalizing Wellness with Cutting-edge DNA Tests San Diego Reference Laboratory Committed to Better Living through Chemistry 20 Diamond Medical Laboratory Providing Unmatched Mobile Healthcare Services 24 28 32
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  • 12. SCL Healthcare Central Laboratory Healthcare is moving from volume-based care to value- based and with it, we can expect the clinical standards to rise and improve quality of life. Research and development of various medicines, therapeutics, and methodologies are not only taking us closer to achieving new milestones in healthcare, but also in revamping the efficiency and reliability of already existing techniques. A leading Korean company, that has been instrumental in carrying out research and development for various healthcare providers is SCL Healthcare Central Laboratory (SHC C-LAB). With three core values- Service, Quality and Research, SHC C-LAB has developed into the largest nationwide clinical laboratory and has acquired the reputation of best reference laboratory in Korea. SCL Healthcare Group is led by its CEO, Kyoung Ryul Lee, M.D., Ph.D. To understand more about the laboratory, its services, its journey through all these years, we bring to you an exclusive interview with Mr. Lee. He discusses, in detail, about the company, their future plans, and various other interesting aspects of the SHC C-LAB and the industry. 1. Kindly share in brief about SCL Healthcare Central Laboratory. Also, tell us about your vision and mission. SCL Healthcare Central Laboratory (SHC C-LAB) is the Korea’s first central Laboratory dedicated to clinical studies. We started central Laboratory business since 2006 as the first and largest central laboratory in Korea. We have been dedicating and carrying out our works in developing new drugs and clinical trials (phase I, II, III, IV), Investigator Initiated Trials (IIT), Sponsor Initiated Trials (SIT), and experiments for research papers. Our experts on clinical trials and experiments help researchers in all process from consultation to result reporting. We promote healthcare that will continue onto future generation by harmonizing the physical, mental and environmental states through consideration and respect The Forefront of Research and Clinical Trial Studies in Korea 10 / August 2019 /
  • 13. Kyoung Ryul Lee M.D., Ph.D, CEO / August 2019 / 11
  • 14. 2. Tell us something about the CEO/Founder/Director/MD of the laboratory. A CEO of SCL Healthcare Group, Kyoung Ryul Lee M.D., Ph.D is a medical doctor specialized in Laboratory Medicine. He graduated Yonsei University College of Medicine. He was a professor at Yonsei University. He became a CEO of SCL Healthcare Group in 2007. He emphasizes to maintain our three key values which are quality, service and R&D. He received the “Order of the Polar Star” from Mongolian government for the first time in field of medicine in 2009, because SCL Healthcare Group founded MOBIO diagnostic Medical Laboratory in Ulan Bator, Mongolia. He also received Global Leader Award from Global Community in 2017. He highlight that the SCL Healthcare Group will double our efforts to satisfy our clients, therefore we will be dedicated to becoming a truly patient-centered Central Laboratory that focuses on evidence-based medicine. 3. What influenced you to start a healthcare laboratory? Share with us your journey so far. As the advancement in new drugs development progresses more globally, the importance of a central laboratory business is being increasingly emphasized in Korea as it is in the United States and Europe. In order to meet these growing demands, SCL Healthcare, a pioneer in clinical diagnostics, established the Korea’s first central laboratory. 4. What was the turning point for SCL Healthcare Central Laboratory, according to you? As clinical trials have increased and customer’s needs have been diversified, I founded SCL Healthcare in 2010 by separating from SCL (Seoul Clinical Laboratories). In addition to the Central Laboratory, we have expanded our business to the Companion Bio-marker Center, Medical Diagnosis, and Bio Logistics. Since then, our clients have high satisfaction and we have currently the highest market share in the domestic Central Laboratory field. Through both quantitative and qualitative improvements, SHC C- LAB will grow into a key global company. 5. What are the unique points/specialties of the laboratory? Tests performed in SHC C-LAB maintain continuity using validated methods. Test results are generally kept in storage until the application for new drug approval and for a longer period of time as requested by our customers. Since the process of developing new drugs takes long, it is usually desired that the same index is used during a clinical study. In order to meet the strict demands, we perform tests continuously with the same validated-test methods. By unifying reference ranges and eliminating deviations that may occur during the analysis of each site, we produces test results that are more easily interpreted and have continuity. In addition, SHC C-LAB reports test results with a data management process specialized for clinical studies and that allows fast and convenient bio-statistical analysis. 6. Apart from technology and applications, what are the other services and solutions that your lab provides? SHC C-LAB puts unsurpassed resources, knowledge and experience in laboratory management to work for customers on each clinical study. We provide experienced project management staff to support the high test level of quality. • National and international communications • Clinical study knowledge resources • Risk management focus with a customer service • Support for kits • Remnant specimen storage • Study data management • Quality assurance 7. How advanced are your lab equipment? SCL Healthcare has state-of-the art equipment including the largest Laboratory Automation System (LAS) in Asia. We have optimal environment for central laboratory testing such as automatic ventilation, automatic temperature and humidity control system for all kinds of esoteric test items. 8. What critical measures do you take to ensure the safety of your employees in the lab? All employees wear a gown, gloves, and a mask when tests are performed and we have safety equipment such as eye wash station and emergency shower station. We also conduct safety management training once a month. 9. Being the key person of the company, one of the main responsibilities is to ensure that the needs of the clients are being met properly. How do you co- ordinate with your team members to guarantee client satisfaction? SCL Healthcare pursues field 12 / August 2019 /
  • 15. management, speed management, and quality management as its management policy. In order to perform accurate test quickly and correctly, employees have ample opportunity and complete the necessary training. The company respects all employees and is committed to maintaining a good and safe working environment. In addition, in order to communicate with clients, staff members regularly visit clients and we develop and provide various tests for the diagnosis and research of diseases through professional academic activities. 10. Share with us the most spectacular client experiences? When we attended an international conference, one of the biggest CROs (Clinical Research Organizations) visited our booth and had a meeting. The company was interested in expanding its business in Asia including Korea, and was an opportunity to introduce our company and talk about possible areas for cooperation. The CRO’s executives then visited our laboratory in Korea, toured the facilities, and discussed specific partnerships. Currently, we are working collaboratively in many parts of domestic and overseas clinical trials, and SHC C-LAB are participating in the field of new drug development with pride as Korea’s representative Central Laboratory. 11. What are the awards and accolades your company has received so far? Certifications: • Acquired CAP (College of American Pathologists) Certification in 1998 as Korea’s first Laboratory participated in CAP • Certified NGSP (National Glycohemoglobin Standardization Program) Level 1 Laboratory every year • Received ISBER (International Society for Biological and Environmental Repositories, USA) • Acquired QMEQAS (CTQ/INSPQ external quality assessment scheme) • Acquired CDC LSP (Centers for Disease Control and Prevention for Lipid Standardization Program) • Acquired CDC Newborn (Centers for Disease Control and Prevention for Newborn Screening and Molecular Biology) • Acquired CDC LAMP (Centers for Disease Control and Prevention for Lead and MultiElement Proficiency) • Received CDC VDSCLP (CDC Vitamin D Standardization- Certification Program) as Asia first laboratory in 2015 • Received G-EQUAS (German External Quality Assessment Scheme) • Received ISO9001 quality management certification in Clinical Laboratory • Acquired GCLP (Good Clinical Laboratory Practice) in 2019 12. What are your future goals? Also, tell us about the ongoing or upcoming projects your company could launch. Our long-term vision is to leap forward as a “Global Medical Company”. We plan to implement the strategy step by step such as establishing new business processes and expanding our global market share. With new paradigm of the medical environment in time of needs, SHC C-LAB will continue to present new business models for customer satisfaction and patient- centered healthcare. 13. What advice would you give to the budding entrepreneurs in the industry? As clinical trials market is expanding and become more complex, the role of the central laboratory is becoming increasingly important. Only laboratories those are well aware of the trends of trials and can work with customer’s needs will be able to grow into a key player in the clinical trial market. • 2017 Global Leader Award from Global Community • 2015 Grand Prize in Medical Asia 2015 • 2015 Ministry of Health and Welfare Award • 2014 Mongolia Ulaanbaatar Railway Service Medal • 2012 Seoul Mayor Award • 2011 Mongolian Ministry of Health, Mongolian Medical Pioneer Medal • 2009 Mongolian President, Arctic Medal • 2009 American Biographical Institute, Top 500 Influential People in the World • 2009 Korea Minister of Health, Welfare and Family Award • 2007 Stevie Award Iba Chief Executive Officer Finalist AWARDS Interview with Insights care / August 2019 / 13
  • 16.
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  • 19. he healthcare sector is moving from reactive care to preventive care. Preventive Tcare helps the patient take necessary precautions to avoid certain conditions and also helps them in identifying the root of a disease before it becomes serious. Additionally, the cost of preventive care is much less than that of reactive care. Diagnostics is a major part of preventive care. All the conventional treatment methods mostly follow the trial and error method, where the illness is guessed based on the symptoms the patient shows. It is necessary to move ahead from this method to personalized care to improve the outcomes of healthcare. Optimum diagnosis is the first step towards this. The diagnostics industry is witnessing immense transformation and there are various new developments that are helping it move towards personalized care. Let'slookattherecentdevicestransformingdiagnostics. Ebola is a highly contagious and deadly virus and once infected, it leaves limited treatment options forthepatient.Moreover,itcanspreadeasilyand startanepidemic.Tocombatthedangersitbrings to the human lives, scientists at the Rochester Institute of Technology (RIT) have developed the prototype of a novel micro device. This device helps diagnose the infection caused by Ebola early,whichresultsinbettertreatmentoutcomes aswellasreducesthespreadofinfections. The developed microfluid device has biosensors attached to it. It is a small, automated chip that has fluorescence sensors attached to it. The device detects the Ebola RNA when the patient's sample is added to it by activating the CRISPR mechanism.Theresearchersarefurthertryingto find a way to generate this device at affordable costs. Better Detection of Ebola Virus with a Microfluid Device Industry Trends / August 2019 / 17
  • 20. KidneyIntelX is the main diagnostic test for kidney diseases devised by Renalytix AI plc. It exhibits promise to improve the clinical management of patients with fast-growing kidney diseases and type-2 diabetes. It helps in better diagnosis and well as treatment of these. KidneyIntelX uses machine learning algorithms to examine the combination of predictive blood- based biomarkers. These include sTNFR1, sTNFR2, and KIM1 along with the electronic health record data. The device is designed to identify the progressive kidney disease. It was designatedasaBreakthroughDevicebyFDA. KidneyIntelX- A Breakthrough Device KidneyIntelX is the main diagnostic test for kidney diseases devised by Renalytix AI plc. It exhibits promise to improve the clinical management of patients with fast-growing kidney diseases and type-2 diabetes. It helps in better diagnosis and well as treatment of these. KidneyIntelX uses machine learning algorithms to examine the combination of predictive blood- based biomarkers. These include sTNFR1, sTNFR2, and KIM1 along with the electronic health record data. The device is designed to identify the progressive kidney disease. It was designatedasaBreakthroughDevicebyFDA. Q-POC – A Revolutionary Diagnostics Kit 18 / August 2019 /
  • 21. MinION, a new DNA sequencing device by Oxford Nanopore, can detect the Huntington's disease a lot faster than the traditional ways. It could therefore drastically reduce the waiting time for number of critical cases of Huntington's disease, as well as other genetic disorders in the future.Moreover,itmeetsthestrictinternational qualitystandardsforlaboratoryuse. MinION is a small device which decodes every DNA strand separately in real-time. This hand- held device can then identify the changes in any DNA sequence to detect the genetic disorder. Being able to do all of this in real-time, the device cutsdownthewaittimefortheresults. A Remarkable DNA Sequencing Device- MinION MinION, a new DNA sequencing device by Oxford Nanopore, can detect the Huntington's disease a lot faster than the traditional ways. It could therefore drastically reduce the waiting time for number of critical cases of Huntington's disease, as well as other genetic disorders in the future.Moreover,itmeetsthestrictinternational qualitystandardsforlaboratoryuse. MinION is a small device which decodes every DNA strand separately in real-time. This hand- held device can then identify the changes in any DNA sequence to detect the genetic disorder. Being able to do all of this in real-time, the device cutsdownthewaittimefortheresults. Mass Spec- Promise of a Better Tomorrow The medical diagnostics industry is advancing at a fast-paced. The new innovations come with a promise to enhance the accuracy of detecting diseases in a human body in real-time. Moreover, the easeofuse,simplicityinmanufacturingaswellastheaffordabilityofthelatestdevicesisimproved. -Aishwarya / August 2019 / 19
  • 22. Offering Diagnostic and Digital Health Solutions for Substance Use and Pain Management spenti Health was established Aby a group of seasoned healthcare leaders who made a commitment to acquire a struggling toxicology lab in Burlington Vermont, three years ago. From the initial days, their vision was to leverage crucial lab data and supplement this vital information in addiction and care recovery with value services including software, health analytics, and leading- edge education. This paradigm shift for a lab, fueled by the opioid crisis and the broader impact that substance use disorder has on communities, families and personal friends, motivated them to innovate continuously and act differently than any other toxicology lab. Aspenti Health ™ is the first lab designed to address population health for substance use and pain management patient through diagnostic and digital health solutions. The Dedicated Duo Aspenti’s CEO, Chris Powell, is a dynamic personality who has over 30 years of enriched experience in healthcare. He started his career with IBM as field sales professional before moving to IDX Systems Corporation, which was acquired by GE Healthcare in 2006. There, Chris worked as the Vice President and General Manager of GE Healthcare Americas Commercial Healthcare IT business, including the United States, Canada, and Central and South America. Chris left GE in 2011 and went on to become CEO at Precyse, a Health Information management (HIM) company that led the healthcare transition to the ICD-10 coding set. Under Chris’ leadership and growth, Precyse was acquired to form nThrive, a healthcare revenue cycle and service company, before coming to Aspenti Health. Jill Warrington MD, PhD, is the Chief Medical Officer of the company has more than two decades of experience in the medical field with a focus on laboratory medicine and substance use care. She is passionate about the role that laboratories can play in optimizing clinical decision making and supporting clinical workflows. Her key areas of interest include driving appropriate utilization of testing services, integrating health analytics to inform care, and reducing administrative burden through automatization of unnecessary operational steps. Distinctive Services and Solutions Aspenti Health is a unique healthcare company in the substance use disorder (SUD) space. Being specifically designed to promote population health for substance use and pain management patients, Aspenti is a state-of the art laboratory that leverages innovative methods for urine drug screening and confirmation testing with wrap-around technology and services. The company is changing the standard of care for SUD patients through Care Coordination, Population-specific Health Analytics, and Education. Aspenti’s Care Coordination tool, Aspenti Navigator a random testing engine schedules and notifies patients for random tested based on the frequency assigned. The company’s software solution alleviates the administrative strain of managing random testing. Aspenti Insights, powered by its advanced business analytics software and data analysts provides real time health analytics to help control costs and improve outcomes. Identifying the ability of population health analytics to support community partners and directly impact patient care, Aspenti has an internal health analytics team and a versatile custom business analytic tool. Using laboratory data, it has deep insights on emerging drug trends, treatment adherence, and the frequency of unexpected findings. Aspenti leverages Aspenti Health ™ 20 / August 2019 /
  • 23. strategic partnerships to gain insights into social determinants of health and align those with emerging drug trends in a meaningful way to deliver the most impactful data. Two of its unique analytics offerings are Patient Population Metrics Report, a quarterly report for providers presenting insights into ordering patterns and emerging drug trends. Another offering is Geospatial Mapping, which is designed to give visibility to community partners on county-level drug use demonstrating marked variability in buprenorphine adherence as well as in fentanyl and heroin use. Aspenti IQ: A Trailblazing e-Learning Facility Aspenti Health’s innovative eLearning offering, Aspenti IQ, leverages the superlative digital learning functionality with its unique subject matter expertise. It delivers CME/CNE accredited courses in clinical best practice, protocol, compliance, patient communication, and many more mission-critical subject areas. Of all the tools available to drive better care and prevent addiction before it starts, education is the company’s most powerful factor that transcends the entire spectrum of care touching not only patients and providers, but also families and friends. All Aspenti IQ courses are mobile-friendly and CME/CNE accredited. Each represents modern learning theory by utilizing micro-learning, scenarios-based concepts and video. Aspenti was chosen as a national partner by HealthStream, the largest Healthcare learning management platform in the country, reaching more than 4,000 healthcare organizations and hosting 4.8 million users. Aspenti will be deploying education to the front lines of care, reinforcing the quality and impact of Aspenti’s eLearning solutions with content such as “Responsible Opioid Care and Pain Management Certification”. It is a 16 course micro-certification track featuring the subject matter such as foundations, compliance, opioid misuse, and pain management. Outstanding Client Experience Aspenti strives hard to maintain loyalty Chris Powell, CEO MEDICAL & CLINICAL LABORATORIES TO WATCH FOR 2019 1 Best T H E Our vision is to create a world where we enrich every life through diagnostic science and compassionate care. Together we can end the human suffering and costs associated with substance use disorder ‘‘ ‘‘ / August 2019 / 21
  • 24. and satisfy its customers at every level. While talking about the same, the company shares one of its memorable client experiences. “The strength of the partnership between Aspenti Health and the University of Vermont Health Network (UVMHN) lies in the alignment of our goals to improve people’s lives. Aspenti Health’s approach is broader than just performing drug testing, by asking what it really takes on a population level to reduce the impact of substance use disorder on people’s lives. The UVMHN Department of Pathology and Laboratory Medicine is working closely with Aspenti Health, sharing the expertise each of brings to solve this national crisis in new ways; using the UVMHN as a place to pilot innovative solutions with new testing methods, education for providers, patients and families, and data analytics to clarify barriers to individuals’success. This is a novel addition to Vermont’s already successful hub and spoke model of care for substance use disorder.”- Debra Leonard, MD, PHD Chair, Pathology and Laboratory Medicine at University of Vermont Medical Center Abiding Core Values Integrity is one of four core values of Aspenti along with innovation, inspiration, and inclusion. The company believes that it is the foundation of the quality and compliance programs that shapes the company. The role of integrity in the company’s operations enters into every aspect of the business model right from conducting its specimen collections and process testing for its patients and providers, to ensuring sound financial processes and compliance standards and interacting within organization and clients. Apart from its core values, Aspenti considers the safety of its colleagues as a critical factor. Along with meeting the standards of key regulatory bodies including the New York State Department of Health, CLIA, and the College of American Pathologists (CAP), the company also invites state and local regulatory organizations to voluntarily inspect its lab. Also, in direct patient interactions, the company has well-trained its colleagues on aggression de-escalation and trauma- informed care to support a safe, non- confrontational environment. Advanced and Secured Lab Equipment Aspenti has a state-of-the lab art laboratory designed with a LEAN, linear workflow and reliant upon sophisticated Liquid Chromatography- Tandem Mass Spectrometry (LC- MS/MS) technology. This technology has been cited as a future of laboratory chemistries and requires highly specialized technical expertise to perform. The team of Aspenti has learned from related-disciplines of environmental toxicology, sports medicine, and forensic toxicology to build this focused clinical laboratory. Jill Warrington, CMO 22 / August 2019 /
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  • 26. DiamondMedical Laboratory Providing Unmatched Mobile Healthcare Services Andrew Diamond CEO 24 / August 2019 /
  • 27. market leader spearheading with its unique Aapproach and methodology in the medical space is Diamond Medical Laboratory. The lab delivers high quality, appropriate, and cost-effective care through its diverse, energetic, and highly trained professional staff. The prime goal of the laboratory is to ensure that customers and patients are serviced in a compassionate and ethical manner in an effort to continuously expand its presence in nursing homes, assisted livings and the homes of seniors. DML works closely with various providers that serve the same population with the goal of keeping their patients healthier and most importantly, keeping them out of the hospital. Why DML? The DML is an expert in providing quality living, nursing homes, and individual homes for seniors to provide services at their location. It provides a phlebotomist and serves the patients in their “Homes”. The lab currently processes over 90% of the specimens in its lab in Owings Mills, MD. Besides, DML is a partner with other local laboratories to run testing to benefit the patients. DML’s owners and office staff are always available to assist its clients. It offers customized services that meet the clients’ unique needs. The laboratory is committed to personal service where one can have the comfort of speaking to a familiar voice every time they call. The team at DML gives equal importance to the commitment for the serving community. DML and its owners donate to many local charities and organizations as a way to give back to the community. Safety and Customer Satisfaction at its Highest Priority On the safety front, SOP’s have been approved by DML’s Medical Director and Lab Manager assuring that the lab complies with all state and medical regulations. The lab also provides OSHA training and regular safety trainings to make sure its staff is always using proper measures to stay safe in the lab. The management staff of DML coordinates through a collaboration portal to resolve client issues permanently and in a timely manner. They also send quarterly reports to the company’s clients containing the information about the test performed, the number of patients they have seen, along with the number of critical results they “Our goal is to ensure customers and patients are serviced in a compassionate and ethical manner to continuously expand our presence in nursing homes, assisted livings, and the homes of seniors MEDICAL & CLINICAL LABORATORIES TO WATCH FOR 2019 1 Best T H E ” / August 2019 / 25
  • 28. have come across. The team also attends their quarterly meetings to exchange information and resolve problems related to client satisfaction. “We take client satisfactions very seriously. I provide my cell phone number to all clients as a way to expedite a resolution. We review all client concerns monthly and ensure that the time frame we respond in is as timely as possible,” says Andrew. The Vibrant Trio at the Laboratory The Founder of Diamond Medical Laboratory is Andrew Diamond. He received an undergraduate degree in Criminology from the University of Maryland College Park. After graduation, Andrew managed a branch of a Nationwide Mortgage Company for 5 years. He eventually sold the business to his partners and created Marvel Title and Escrow. In 2014, he purchased ownership in Mobile Medical Imaging, a portable imaging company and increased the revenue by over 400% in just the span of 2 years. Andrew was approached by a representative from a skilled nursing facility about opening a medical laboratory to serve their residents in October 2016. That is when the decision to open Diamond Medical Laboratories was made. Mike Kluttz, the CEO of DML is a graduate of UMBC with an undergraduate degree in business management and biology. He has over 35 years of experience with various laboratories and for last 24 years he has been in a management position. Mike has been the acting CEO of the clinical laboratory for approximately 4 years. Another important persona at DML is David Robinson, the Chief Laboratory Officer of the lab. He is an army veteran having 27 years of enriching experience in clinical and research laboratories. He has handled diverse positions in the field, right from Phlebotomist to Laboratory Supervisor and even as a Clinical Research Coordinator. He has also worked in small laboratories, field hospitals, and even large medical centre laboratories. For the past 4 years, he has worked as the Laboratory Service Manager at DML. Future Goals Diamond Medical Laboratory wishes to serve 100 skilled nursing facilities along with 30 assisted livings and 100 home bound patients a day. The laboratory will be putting together an antibiotic or anti-microbial stewardship program to assist its Skilled Nursing Facilities in compliance with Federal mandates. Besides, it is also looking forward to initiating more molecular testing to provide its clients with faster results, which would avoid re-administer to the hospital. 26 / August 2019 /
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  • 30. n award-winning and renowned market leader Athat has a big vision for UK healthcare is DNAfit, part of the Prenetics Group. The company is eager to put power in people’s hands to take charge of their health using their bodies as the best source of intelligence. DNAfit is helping people reach their wellness goals faster, as well as playing its role in reducing pressure on the NHS. In 2018, DNAfit were acquired by Prenetics, giving it a depth into the range of available genetic tests. Prenetics is a leading genetic testing and digital health company headquartered in Hong Kong and London and has offices in 10 countries globally. Prenetics owns laboratories, conduct and publish their scientific research. It has over US $50m in strategic investments from Alibaba and Ping An, making them one of the fastest-growing genetic testing and digital health groups globally. Later this year, DNAfit has plans to get behind various preventive diseases that can help people make preventative lifestyle changes. Why DNAfit? DNAfit has a mission to use genetics to transform the health and wellness outlook for millions of people. The DNAfitPersonalizing Wellness with Cutting-edge DNA Tests Avi Lasarow Founder & CEO 28 / August 2019 /
  • 31. company strives to reduce and prevent lifestyle-related health conditions, making everyone live longer, healthier, and happier lives. It has a vision to not only make people aware of what their bodies need to be healthy, but also to motivate them to be proactive in making positive changes to benefit their health. DNAfit has published the world’s first genetically guided exercise intervention study, alongside many other studies looking at gene x environment interaction. Its products provide a lab report along with the personal one to one health coaching, online exercise, and meal planning platforms and at-home blood testing. The Influential Leader Avi Lasarow, the Founder and CEO of DNAfit has dedicated over a quarter of his life in the relentless pursuit of science and technological innovation. He is driven to pioneer and humanize science that was unreachable, unexplainable and unaffordable for so long, His sheer commitment to making DNA results more accessible has meant that thousands of people across the world can live happier & healthier. The Inception Story Having worked in the life sciences industry for several years, Lasarow was much aware of the life-changing potential of health technology, but it was his personal experience that made him realize the important role of personalization in getting people to make healthier choices. After selling his previous company, Lasarow started to focus on getting fit and healthy. At that point, he began looking at the role that genetics plays in how we respond to different kinds of exercise and nutrition. Lasarow noticed that, although genetics was becoming increasingly popular for ancestry, nobody was concerned with using their genetic profile to inform their health and wellbeing choices. He saw this as an opportunity to help people put their genetic data into action and began applying this personalized approach to his own nutrition and workouts. Achieving great results and seeing the amazing impact genetic insight can have led Lasarow to create DNAfit as a way to help others reach their health goals. Assuring Safety and Quality with Cutting-edge Technology DNAfit uses advanced technologies in all of its laboratories and uses small targeted PCR analysis, custom Illumina SNP array analysis and Whole Exome Sequencing for all parts of its services. The company applies gold-standard Agile project management methodologies across its whole business and client communications following Prince2 & PMP protocols. Also, each client of DNAfit is assigned a ‘partner implementation manager’, who liaises directly with the client. The partner implementation manager looks after their needs and timelines are communicated accordingly. This provides a single, consolidated voice to the client, along with providing the power of the wider team to move quickly and deliver a quality service. We're Eager To Put More Power In People’s Hands To Take Charge Of Their Health, Using The Best Possible Source Of Intelligence- Their Bodies ‘‘ ‘‘ MEDICAL & CLINICAL LABORATORIES TO WATCH FOR 2019 1 Best T H E / August 2019 / 29
  • 32. Salient Client Experience DNAfit has been working immaculately to provide its clients with innovative services and its happy customers bring the same reflection with their valuable feedbacks. One of its clients shares the experience and delivers- “If you genuinely care about your health and well-being, this is for you! I signed up for this through my company’s perks and I am so glad! The results of the DNA test was very much on par with my personal medical history and experience. I have found the resources available to you invaluable and I use the fitness portal and also created some meal plans. The consultation with the sports scientist was spot on, comprehensive and yet broken down to basics to help you understand your report. The whole experience has created a real buzz in the office and boosted overall morale on my pod.” - Sheila Bynoe Cert CII (Health and Protection), Client Relationship Manager at Chase de Vere Independent Financial Advisers Limited (a Swiss Life company) Awards and Accolades In 2015, DNAfit was awarded the ‘Lloyds Bank National Business Award for Innovation’ and was named in ‘The Fast Company’s Top 10 Most Innovative Businesses in the Data Science sectors’ which had alongside names such as Netflix, Spotify and NASA. DNAfit were also presented with the Board of Trade Award in audience of a UK Prime Minister. Most recently, DNAfit is honoured to have been awarded ‘The Queen’s Award’ in two categories namely the highest official UK Awards for British businesses, and another for the Innovation and International Trade. 30 / August 2019 /
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  • 34. an Diego Reference SLaboratory (SDRL) is a full- service, client-focused analytical biomedical testing laboratory first licensed in January of 1989 as a commercial clinical laboratory. The founding purpose of the laboratory was to provide clinical and toxicological laboratory services to the law enforcement community, private industry for pre-employment testing, and drug treatment clinics. SDRL has been a leader in the toxicology and clinical laboratory testing field for over twenty-five years and has been a pioneer in methadone drug testing since 1993. The laboratory’s core mission is to provide the highest quality of testing, superior customer service, and competitive pricing to a broad range of clients throughout the United States. It is dedicated to meeting the needs of its customers by delivering comprehensive clinical and drug testing toxicology services with a commitment to accuracy, expediency, and accessibility. Distinctiveness of the Lab At SDRL, the team takes pride in the technical expertise and assistance they can offer clients. The team communicates daily with their clients, learns about new trends in the addiction community, and continually expands the testing menu accordingly. They support these expanded tests with Technical Briefs, which are informative bulletins sent to the clients that explain the test and its interpretation. In 2011, SDRL initiated writing The Toxicology Times (toxtimes.com), a monthly publication for clinicians and counsellors. This monthly publication reviews various topics surrounding the interpretation of clinical results, drugs, metabolism, elimination and impact on the patients’ health. With this depth of technical expertise, the lab is recently certified to provide Continuing Education Units (CEU’s) to its client’s technical staff. SDRL’s client service phone lines are always answered by a live customer executive. The lab’s senior management, including the CEO, is also available for more in depth and technical explanations. In order to maintain certain licenses and certifications, SDRL participates in several proficiency programs including California Methadone Drug Analysis Laboratory Proficiency program, Pennsylvania Proficiency Testing, as well as the College of American Pathologists Forensic Drug Testing (CAP FDT). How was SDRL Established? The lab was started in 1989 in response to the change in the testing marketplace. There was a developing need in the opiate treatment clinics for reliable and cost-effective toxicology testing that was performed quickly and accurately. The California laboratory license requirements to provide services to these treatment organizations are very rigorous and quite exacting. The license is built around definitive drug testing procedures and blind proficiency testing. With “blind” proficiency testing, the proficiency samples are sent to the clients of the testing laboratory. They are then repackaged and relabelled with pseudo patient names and submitted to the laboratory. The Committed to Better Living through Chemistry 32 / August 2019 /
  • 35. laboratory performs the tests and reports the results to the clinic. These results are then sent to the regulatory agency by the client. Proficiency testing is done on a monthly basis with a variable number of samples and the laboratory must maintain a score of 90% or greater to maintain licensure. There was also a need to offer clinical and wellness testing to the patients in the programs, which was not being offered at that time. Today, SDRL supports the physicians with functional testing in serology, hematology, and immunology as well as liver function tests. This testing supports the clinical maladies that result from drug addiction. Avant-garde Lab Equipment SDRL utilizes the latest cutting-edge laboratory technology where all specimens are barcoded with a unique number and are tracked throughout the laboratory testing process with an exact chain-of-custody. The initial analysis of the specimen is performed by high-speed analytical instruments for reliable and quick identification of various levels of substances by drug class. At the lab, the specimens are stored in a secure facility to make them available for further testing. All reporting is done same day; results are available on the clinic’s web portal in a secure fashion and are available for review anytime. Furthermore, confirmations can be performed on abnormal results to identify the specific analyte of the drug class by state of the art HPLC/MS/MS or GC/MS methodology. With its up-to-date quality control, SDRL makes QC results available to its clients as further assurance of their work. Dr. Joseph Graas Lab Director MEDICAL & CLINICAL LABORATORIES TO WATCH FOR 2019 1 Best T H E / August 2019 / 33
  • 36. With regards to safety, SDRL is a drug-free workplace and has a strict drug testing policy and enforcement of such requirements. All employees are trained, and follow, Standard Operating Procedures (SOP’s) as required by each department. The lab maintains proper training checklists for all employees to ensure proper procedures are being followed. In conjunction with training, they have safety meetings with all employees, maintain a safety monitor in each section, and provide appropriate Personal Protective Equipment (PPE). About the Leading Light Dr. Joseph Graas, the founding member of SDRL, is the Laboratory Director. Dr. Graas holds a PhD in clinical chemistry and toxicology and has an extensive background in the field. Having participated in laboratory operations for nearly fifty years, he is considered as an expert in the field of toxicology and has been retained to testify in court in many state and federal cases. He is a member of the American Chemical Society, American Association for Clinical Chemistry, California Association of Toxicologists, and a Fellow of the American Institute of Chemists and National Academy of Clinical Biochemistry. Dr. Graas has many technical publications and patents in the field of Chemistry. Bringing in Quality The team of SDRL works with clients to solve any issues they might experience and help explain results both verbally and with supported documentation, such as the Toxicology Times. They attend and present at various conferences to learn new information in the field, have added new testing techniques, and have expanded their test menu to assist their clients keep up with new trends in drug abuse. SDRL has taken special projects for clients to help them further understand what’s going on with their patients, specifically pregnant females taking methadone, medication interactions, and dosage compliance. Happy Clients of SDRL SDRL shares some of the memorable feedbacks from its clients. • “We are so pleased with our decision to change labs. Every aspect of SDRL’s service is superior to what we were receiving. SDRL continues to surpass our expectations. Real people answer the phone, and everyone is helpful and knowledgeable.”- J. F. – Owner/Executive Director, California” • “The level of service I receive from SDRL is unmatched – they make me feel like I’m the only customer they have. I would highly recommend SDRL to anyone searching for a supportive, trustworthy and responsive laboratory!”- D.M. – Owner, Illinois Other Services SDRL has implemented a 2D barcode system that allows for efficient and error free receipt of the patient samples and tracking throughout the testing and storage process. Its clinical testing is geared towards the treatment of the patients. The lab also streamlines the process from the clinic to the laboratory and customizes services for each client. So, it’s not a ‘one size fits all’. Future Goals SDRL wishes to expand the clinical laboratory testing and to launch Therapeutic Drug Monitoring for all medications offered by client physicians in the treatment of their patients. The laboratory is also planning to monitor the spread of fentanyl and fentanyl analogues in its patient population and to expand its clinical testing menu to include health and wellness testing. Additionally, SDRL will continue to focus on maintaining and improving customer care and enhancing quality management. We Are Dedicated To Meeting The Needs Of Our Customers By Delivering Comprehensive Clinical And Drug Testing Toxicology Services ‘ 34 / August 2019 /