CHI's 10th Annual Next Generation Dx Summit, August 20-24, 2018, Washington, DC

Next Generation
SUMMIT
Setting the stage for the
great minds of diagnostics to
advance medicine together
August 20 - 24, 2018 | Grand Hyatt Washington | Washington, DC
PREMIER SPONSOR
NextGenerationDx.com
International Diagnostic
Professionals
1,000+
Scientific and Technology
Presentations
250+
Industry-Leading Sponsors
and Exhibitors
90+
Diverse Conference
Programs
14
A Division of Cambridge Innovation Institute
Cambridge
HEALTHTECH
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2018
CONFERENCE STREAMS
REGISTER BY APRIL 27
SAVE up to $
450!
The 10th
annual Next Generation
Dx Summit has grown to include
14 distinct meetings with
weeklong coverage in these
important areas:
CONFERENCE-AT-A-GLANCE
PLENARY KEYNOTES
SPONSORSHIP
HOTEL & TRAVEL
REGISTRATION INFORMATION
SHORT COURSES
MOLECULAR BIOPSY
IMMUNO-ONCOLOGY
RAPID TESTING
PRECISION MEDICINE
BUSINESS

Next Generation Dx Summit Celebrates 10 Years
Since 2009, the diagnostics community has united at Next Generation Dx Summit to discuss trend-setting
developments, milestones, challenges and opportunities in the industry. A decade later, the diagnostics
industry has paved the path to the precision medicine era with tremendous advancement in rapid and
non-invasive testing, cancer detection and monitoring, and expanding applications of clinical sequencing.
As the market demands faster and more precise diagnostics, and regulatory and reimbursement conditions continue
to evolve, diagnostic professionals need a comprehensive event that can help them build partnerships, gain industry
knowledge, and network with and learn from their peers. Next Generation Dx Summit provides a venue to advance the
science of diagnostics and improve the practice of medicine.
August 20 - 21 Monday PM - Tuesday
PART A CONFERENCES
August 22 -23 Wednesday - Thursday AM
PART B CONFERENCES
August 23 -24 Thursday PM - Friday
PART C CONFERENCES
PRECONFERENCE
SHORT COURSES
August 20
Monday AM
DINNER SHORT
COURSES
August 21
Tuesday PM
DINNER SHORT
COURSES
August 23
Thursday PM
Enabling Point-of-Care Diagnostics
Molecular Diagnostics for
Infectious Disease
Biomarkers for Cancer Immunotherapy
and Combinations
Companion and Complementary
Diagnostics in Immuno-Oncology
Circulating Tumor Cells Clinical Application of Cell-Free DNA Single Cell Analysis
Single Cell Analysis
Clinical NGS Assays: Interpretation and
Clinical Utility
Sample Prep, Assay Development
and Validation
Precision Medicine
Companion Diagnostics: Strategy and
Partnerships
Commercializing Molecular Diagnostics
in Pharma, Healthcare and the Clinic
Coverage and Reimbursement
for Advanced Diagnostics
STREAM
Extensive Coverage of DNA Forensics, NGS Labs and More
RAPID
TESTING
MOLECULAR
BIOPSY
IMMUNO-
ONCOLOGY
PRECISION
MEDICINE
BUSINESS
Microfluidics & Lab-on-a-Chip
Devices for POCT
M T W T F
Conference-at-a-Glance
NextGenerationDx.com | 2CONNECT WITH US #NGDx18
Cambridge
HEALTHTECH
Institute
2018
CONFERENCE STREAMS
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The 10th
important areas:
PLENARY KEYNOTES
SPONSORSHIP
HOTEL & TRAVEL
SHORT COURSES
MOLECULAR BIOPSY
IMMUNO-ONCOLOGY
RAPID TESTING
PRECISION MEDICINE
BUSINESS

NextGenerationDx.com | 3
PLENARY SESSIONS
MONDAY, AUGUST 20, 2018
Sponsored by4:15 pm Chairperson’s Remarks
Charles Mathews, Principal, ClearView Healthcare Partners
4:25 - 5:45 pm Global Dx Insights: Policy and Prediction for
Diagnostics
Moderator: Cecilia Schott, PhD, Vice President, Precision Medicine,
AstraZeneca
• Will value-based medicine replace fee-for-service?
• PAMA impact on reimbursement
• Changes in LDT oversight policy
• Changing landscape of IVD regulation in U.K. and Europe after Brexit
• What is the future of molecular diagnostics in medical care?
• How will these policy changes affect the patient?
Panelists:
Dennis J. Dietzen, PhD, DABCC, FAACC, President, AACC; Professor of
Pathology & Immunology and Pediatrics, Washington University School of
Medicine; Medical Director of Laboratory Services, St. Louis Children’s Hospital
John Leite, PhD, Vice President, Oncology Market Development, Illumina
J. Leonard Lichtenfeld, MD, MACP, Deputy CMO, American Cancer Society, Inc.
Mya Thomae, Regulatory Advisor
Victoria M. Pratt, PhD, FACMG, Director, Pharmacogenomics and Molecular
Genetics Laboratories, Department of Medical and Molecular Genetics, Indiana
University School of Medicine (AMP President-Elect)
Susan Van Meter, Executive Director, AdvaMedDx
Ian S. Young, MD, PhD, Chief Scientific Advisor, Department of Health (Northern
Ireland) and President, Association for Clinical Biochemistry and Laboratory
Medicine (ACB), UK
THURSDAY, AUGUST 23, 2018
11:15 am Chairperson’s Remarks
Co-Organized with
11:20 am - 12:00 pm TECHNOLOGY PANEL:
Disruptive Technologies in Lab Medicine
Moderator: Gregory J. Tsongalis, PhD, HCLD, CC, Professor, Pathology; Director,
Laboratory for Clinical Genomics and Advanced Technology (CGAT), Department of
Pathology and Laboratory Medicine, Dartmouth Hitchcock Medical Center and The
Audrey and Theodor Geisel School of Medicine at Dartmouth
• What is appropriate test utilization?
• How do you ensure both user and patient safety?
• How are tests implemented in the clinical setting?
• How do they get regulated?
• How do results get reported?
• How do you enforce quality control in implementation?
• How does it impact emerging applications such as liquid biopsies,
infectious disease outbreaks, and POC diagnostics?
Panelists:
Rakesh Nagarajan, MD, PhD, Chief Biomedical Informatics Officer, PierianDx
Additional Panelists to be Announced
12:00 - 12:45 pm Changing Approaches to Sustainable Funding
in Diagnostics
Moderator: Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates
Today, many innovators in the diagnostics industry struggle for funding, and
yet news of large scale acquisitions or large (over $30M) funding rounds pops
up regularly. How can innovators better understand the changing dynamics
of the funding environment to succeed? How can investors know if they are
getting exposed to the potentially best investments? Whether government or
private, what drives the final difficult decisions and how can companies raise
their chances of success? This session features leaders from several different
channels of funding for innovators, including the NIH, other federal programs,
and corporate and traditional venture investors.
Panelists:
Alex DeWinter, PhD, Managing Director, GE Ventures
Tyler Merkeley, BARDA’s CARB-X Program Manager, Health Scientist, Division
of CBRN Countermeasures, BARDA
Todd Haim, PhD, Program Director, National Cancer Institute SBIR
Development Center
Wouter Meuleman, PhD, Director, Venture Investments, Illumina Ventures
CEO, Atlas Genetics
Cambridge
HEALTHTECH
Institute
2018
CONFERENCE STREAMS
SAVE up to $
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The 10th
important areas:
PLENARY KEYNOTES
SPONSORSHIP
HOTEL & TRAVEL
SHORT COURSES
MOLECULAR BIOPSY
IMMUNO-ONCOLOGY
RAPID TESTING
PRECISION MEDICINE
BUSINESS

SPONSORS
PREMIER SPONSOR
CORPORATE SPONSORS
CORPORATE SUPPORT SPONSORS
MICRO-ENGINEERING / MEDICAL / MANUFACTURING
Cambridge
HEALTHTECH
Institute
2018
CONFERENCE STREAMS
SAVE up to $
450!
The 10th
important areas:
PLENARY KEYNOTES
SPONSORSHIP
HOTEL & TRAVEL
SHORT COURSES
MOLECULAR BIOPSY
IMMUNO-ONCOLOGY
RAPID TESTING
PRECISION MEDICINE
BUSINESS

SPONSOR OPPORTUNITIES
Comprehensive sponsorship packages allow you to achieve your objectives before, during, and long after the event. Signing on earlier will allow you
to maximize exposure to hard-to-reach decision-makers.
Podium Presentations — Available within Main Agenda!
Showcase your solutions to a guaranteed, targeted audience through a 15- or
30-minute presentation during a specific conference program, breakfast, lunch,
or separate from the main agenda within a pre-conference workshop. Package
includes exhibit space, onsite branding, and access to cooperative marketing
efforts by CHI. For the luncheon option, lunches are delivered to attendees who
are already seated in the main session room. Presentations will sell out quickly,
so sign on early to secure your talk!
One-on-One Meetings
Select your top prospects from the pre-conference registration list. CHI will reach
out to your prospects and arrange the meeting for you. A minimum number of
meetings will be guaranteed, depending on your marketing objectives and needs.
A very limited number of these packages will be sold.
Invitation-Only VIP Dinner/Hospitality Suite
Sponsors will select their top prospects from the conference preregistration
list for an evening of networking at the hotel or at a choice local venue. CHI will
extend invitations and deliver prospects, helping you to make the most out of
this invaluable opportunity. Evening will be customized according to sponsor’s
objectives. (i.e.: Purely social, Focus group, Reception style, Plated dinner with
specific conversation focus)
EXHIBIT
Exhibitors will enjoy facilitated networking opportunities with qualified delegates.
Speak face-to-face with prospective clients and showcase your latest product,
service, or solution.
Additional branding & promotional opportunities include:
• Footprint Trails
• Conference Tote Bags
• Literature Distribution (Tote Bag Insert
or Chair Drop)
• Badge Lanyards
• Padfolios
• Program Guide Advertisement
• Meter boards
• Water bottles
• Notepads
Looking for additional ways to drive leads to your sales team?
CHI’s Lead Generation Programs will help you obtain more targeted, quality
leads throughout the year. We will mine our database of 800,000+ life science
professionals to your specific needs. We guarantee a minimum of 100 leads per
program! Opportunities include:
• Live Webinars
• White Papers
• Market Surveys
• Podcasts and More!
2017 ATTENDEE
DEMOGRAPHICS
FOR MORE INFORMATION,
PLEASE CONTACT:
COMPANIES A-K
Jon Stroup
Senior Manager, Business Development
T: 781.972.5483
E: jstroup@healthtech.com
COMPANIES L-Z
Joseph Vacca, M.S.
Director, Business Development
T: 781.972.5431
E: jvacca@healthtech.com
COMPANY TYPE
■ IVD & Pharma 55%
■ Academic Labs 11%
■ Hospital Labs 11%
■ Payers & Insurers 9%
■ Government 7%
■ Services & Societies 6%
■ Press 1%
DELEGATE TITLE
■ Executive & Director 40%
■ Scientist/Technologist 19%
■ Sales & Marketing 18%
■ Professor 11%
■ Manager 10%
■ Assistant 2%
GEOGRAPHIC LOCATION
■ United States 87%
US Breakdown
East Coast 55%
West Coast 29%
Midwest 16%
■ Europe 6%
■ Asia 4%
■ Rest of World 3%
Exhibit Floor Plan
Exhibitor Prospectus
Cambridge
HEALTHTECH
Institute
2018
CONFERENCE STREAMS
SAVE up to $
450!
The 10th
important areas:
PLENARY KEYNOTES
SPONSORSHIP
HOTEL & TRAVEL
SHORT COURSES
MOLECULAR BIOPSY
IMMUNO-ONCOLOGY
RAPID TESTING
PRECISION MEDICINE
BUSINESS

Separate Registration Required
SHORT COURSES
MONDAY, AUGUST 20 | Morning, 9:00 am - 12:00 pm
SC1: Liquid Biopsy: Technology, Applications, Regulations and
Reimbursement
Hatim Husain, MD, Physician, Medical Oncology, University of California, San Diego
John Simmons, PhD, Director, Translational Science & Diagnostics, Personal
Genome Diagnostics
SC2: Regulatory and Reimbursement Issues with Advanced
Diagnostics and Circulating Biomarkers
Živana Težak, PhD, Associate Director for Science and Technology, Office of
In Vitro Diagnostics and Radiological Health (OIR), CDRH/FDA
Girish Putcha, MD, PhD, Director of Laboratory Science, MolDx, Palmetto GBA
SC3: Cell-Based Biomarkers for Cancer Immunotherapy Discovery
and Development
Iulian Pruteanu-Malinici, PhD, Biostatistics, Investigator II, Lab Head, Novartis
Institutes for BioMedical Research (NIBR)
Mark Edinger, Scientific Affairs Director, Flow Cytometry, Q2 Solutions
SC4: Technologies, Applications and Commercialization of
Point-of-Care Diagnostics
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH
SC5: NGS Diagnostics: Technology, Regulation and Reimbursement
of ctDNA Pan Cancer Panels
Chris Karlovich, PhD, Associate Director (Contractor), Molecular
Characterization Laboratory (MoCha), Leidos BioMedical Research, Inc.,
Frederick National Laboratory for Cancer Research
Soma Ghosh, PhD, Scientific Reviewer Molecular Genetics & Pathology, Office
of In Vitro Diagnostics & Radiological Health, FDA
Dana W.Y. Tsui, PhD, Assistant Attending Geneticist; Member, Center for
Molecular Oncology, Memorial Sloan Kettering Cancer Center
TUESDAY, AUGUST 21 | Dinner, 6:45 - 9:15 pm
SC6: Rapid Diagnostics for Antimicrobial Stewardship
Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and Virology,
Children’s Hospital Los Angeles; Assistant Professor, Pathology and Laboratory
Medicine, Keck School of Medicine, University of Southern California
April Abbott, PhD, D(ABMM), Director, Microbiology, Deaconess Health System
Amanda Harrington, PhD, Associate Professor, Pathology; Medical Director,
Microbiology, Loyola University Medical Center
SC7: Practical Considerations for NGS Data Analysis and Interpretation
Robert D. Daber, PhD, Founder and CEO, Gnosity Consults
Matthew Lebo, PhD, FACMG, Director, Bioinformatics, Partners Personalized
Medicine; Instructor, Pathology, Brigham and Women’s and Harvard Medical School
SC8: Commercialization Boot Camp: Manual for Success in
Molecular Diagnostics
Harry Glorikian, Healthcare Consultant
Stan Skrzypczak, Vice President, Corporate Development and Reimbursement,
Guardant Health, Inc.
THURSDAY, AUGUST 23 | Dinner, 6:30 - 9:00 pm
SC9: Microfluidics and Lab-on-a-Chip Devices for POCT:
Technologies and Commercialization
Chris Myatt, Founder & CEO, MBio Diagnostics, Inc
Marta Fernandez Suarez, Daktari Diagnostics & FIND
Additional Instructors to be Announced
SC10: Leveraging Key Opinion Leaders (KOLs): Building a Bridge
Between R&D and Commercialization of Companion and Non-
Companion Diagnostics
Lawrence J. Worden, Principal, IVD Logix
Peggy Robinson, Vice President, Angle PLC
SC11: Single-Cell RNA-Seq: Differential Expression Analysis and
Quality Control
Michael Steinbaugh, PhD, Research Associate, Biostatistics, Harvard T.H.
Chan School of Public Health
CCO, Vortex Biosciences
Cambridge
HEALTHTECH
Institute
2018
CONFERENCE STREAMS
SAVE up to $
450!
The 10th
important areas:
PLENARY KEYNOTES
SPONSORSHIP
HOTEL & TRAVEL
SHORT COURSES
MOLECULAR BIOPSY
IMMUNO-ONCOLOGY
RAPID TESTING
PRECISION MEDICINE
BUSINESS

Cambridge Healthtech Institute Training Seminars offer real-life case studies,
problems encountered and solutions applied, along with extensive coverage
of the academic theory and background. Each training seminar offers a mix of
formal lecture and interactive discussions and activities to maximize the learning
experience. These training seminars are led by experienced instructors who
will focus on content applicable to your current research and provide important
guidance to those new to their fields.
MONDAY, AUGUST 20 AND TUESDAY, AUGUST 21
DAY 1
1:30 pm – 5:45 Training Seminars in Session
5:45 pm – 7:00 Welcome Reception
DAY 2
8:30 am – 6:00 pm Training Seminars in Session
12:30 pm –1:30 Lunch Provided
Refreshment breaks and exhibit hall viewing hours also provided.
TS6A: NGS for DNA Forensics
While current technologies being used in the field of forensics are effective and
efficient, next-generation sequencing is capable of ushering in a new era of DNA
forensics. Cambridge Healthtech Institute’s NGS for DNA Forensics training seminar
will address technical considerations including bioinformatics and mixture analysis, as
well as examine exciting use cases in missing persons. This seminar will also examine
the rigorous challenges of implementation, including documentation and validation.
Forensic scientists, DNA analysts, forensic chemists, criminalists, medical examiners,
and trial attorneys will all learn valuable information from this training seminar.
Instructors:
Seth A. Faith, PhD, Research Leader, CBRNE Defense/Applied Genomics, Battelle
Rebecca Just, PhD, Visiting Scientist, DNA Support Unit, FBI Laboratory
Charla Marshall, PhD, Chief, Emerging Technologies Section, Armed Forces DNA Lab
Adam Garver, MFS, Forensic Scientist – CODIS, Office of Ohio Attorney General
WEDNESDAY, AUGUST 22 AND THURSDAY, AUGUST 23
DAY 1
12:30 pm – 1:30 Lunch Provided
5:30 pm – 6:30 Networking Reception
DAY 2
TS6B: Handheld Device Engineering:
Transitioning from the Lab to the Marketplace
“Disruptive” technology is not disruptive until it is available. This course will
examine the steps, stages, strategies and disciplines necessary to engineer and
launch a medical device that is based on a new technology.
This course is intended to benefit teams, especially start-ups, that intend to
commercialize their inventions and discoveries as marketable devices. Attendees
will benefit from the instructors’ decades of experience in engineering and launching
products that include wearable, handheld, and benchtop electronic devices.
Instructors:
W. Kevin Carpenter, CTO, Porticos
Ludmila V. West, New Product Development Lead, Porticos, Inc.
THURSDAY, AUGUST 23 AND FRIDAY, AUGUST 24
DAY 1
2:00 pm – 6:00 Training Seminars in Session
DAY 2
12:30 pm – 1:30 Lunch Provided
TS3C: Clinical NGS Laboratory from A to Z
Nearly 10 years after the first publication of next-generation sequencing, this paradigm
shifting technology has progressively migrated into the clinical diagnostic space. A
diversity of clinical diagnostic assays is now routinely performed on a variety of NGS
platforms, spanning from single gene to multi-gene sequencing, to genome wide
analyses for the detection of germline and somatic mutations. For clinical laboratories
with NGS experience, and especially for those just starting to use the technology,
designing and operationalizing robust NGS assays remains a challenge. This training
seminar will review principles and diagnostic approaches for NGS assays as applied
to molecular oncology and inherited disorders, platforms and instruments, as well as
laboratory accreditation and proficiency testing specific to NGS.
Instructors:
Jamie Platt, PhD, Managing Director, BRIDGenomics, LLC
Martin Siaw, PhD, MB(ASCP), Technical Consultant, Siaw Consulting
Each CHI Training Seminar offers 1.5 Days of instruction with start and stop times for
each day shown above and on the Event-at-a-Glance published in the onsite Program &
Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as
applicable, and lunch will be provided to all registered attendees on the full day of the class.
Each person registered specifically for the training seminar will be provided with a
hard copy handbook for the seminar in which they are registered. A limited number of
additional handbooks will be available for other delegates who wish to attend the seminar,
but after these have been distributed no additional books will be available.
Though CHI encourages track hopping between conference programs, we ask that Training
Seminars not be disturbed once they have begun. In the interest of maintaining the highest
quality learning environment for Training Seminar attendees, and because Seminars are
conducted differently than conference programming, we ask that attendees commit to
attending the entire program, and NOT engaging in track hopping, as to not disturb the
hands-on style instruction being offered to the other participants.
NextGenerationDx.com | 7A Division of Cambridge Innovation Institute
Cambridge
HEALTHTECH
Institute
2018
CONFERENCE STREAMS
SAVE up to $
450!
The 10th
important areas:
PLENARY KEYNOTES
SPONSORSHIP
HOTEL & TRAVEL
SHORT COURSES
MOLECULAR BIOPSY
IMMUNO-ONCOLOGY
RAPID TESTING
PRECISION MEDICINE
BUSINESS

RAPID TESTING
Cambridge
HEALTHTECH
Institute
2018
CONFERENCE STREAMS
SAVE up to $
450!
The 10th
important areas:
PLENARY KEYNOTES
SPONSORSHIP
HOTEL & TRAVEL
SHORT COURSES
MOLECULAR BIOPSY
IMMUNO-ONCOLOGY
RAPID TESTING
PRECISION MEDICINE
BUSINESS
The Rapid Testing Stream at Next Generation
Dx Summit focuses on the latest science
and novel technologies to improve clinical
outcomes in infectious disease and
oncology. State-of-the-art devices and testing
methods will be highlighted along with
strategies to continue moving diagnostics
to the market and clinic. This stream will
examine how top medical centers and
diagnostic companies are applying new
science and technology in developing the
next generation POC tests and devices.
2018 RAPID TESTING CONFERENCE PROGRAMS
AUGUST 20-21
AUGUST 22-23
Molecular Diagnostics for Infectious Disease
AUGUST 23-24
Microfluidics and Lab-on-a-Chip Devices for POCT
A

RAPID TESTING
CAMBRIDGE HEALTHTECH INSTITUTE’S 12TH
ANNUAL | AUGUST 20-21, 2018
Delivering Rapid Results to Improve Outcomes
Recommended Short Course*
SC4: Technologies, Applications and Commercialization of Point-
of-Care Diagnostics
*Separate registration required, please see page 6 for details
MONDAY, AUGUST 20
12:00 pm Main Conference Registration
KEYNOTE SESSION
1:30 Chairperson’s Opening Remarks
Gerald J. Kost, MD, PhD, MS, FAACC, Director, Point-of-Care Testing Center
for Teaching and Research (POCT•CTR), Emeritus Professor, School of
Medicine, University of California, Davis
1:40 Implementing Point-of-Care Testing to Improve Outcomes
Kent Lewandrowski, MD, Associate Chief of Pathology, Director, Pathology
Laboratories and Molecular Medicine, Massachusetts General Hospital;
Professor, Pathology, Harvard Medical School
Many devices have been developed that permit a wide menu of tests to
be performed at the point of care (POC). Typically, POC tests are more
expensive on a unit cost basis than testing performed in a centralized
laboratory. It is therefore important to demonstrate an improvement in
outcomes when implementing POC testing. This presentation will review
cases from the literature that demonstrated improved outcomes resulting
from POC testing in hospital and outpatient settings.
2:10 Point-of-Care Molecular Diagnostics for Ebola, Zika, and
Other Highly Infectious Diseases—Have We Arrived or Just Begun?
Gerald J. Kost, MD, PhD, MS, FAACC, Director, Point-of-Care Testing Center
for Teaching and Research (POCT•CTR), Emeritus Professor, School of
Medicine, University of California, Davis
Outbreaks and natural disasters impact national economies adversely and
devastate limited resource countries. Ebola demonstrated unequivocally
the need for point-of-care testing in isolation laboratories and field sites.
Our goal is to assess whether molecular diagnostics are adequate to rapidly
detect and stop highly infectious threats in the US and abroad. Novel POC
technologies and international leadership enhance responses to community
epidemics and global pandemics, but are we ready for this uncertain future?
2:40 Human Centric Design Considerations for Developing Point-
of-Care Diagnostics
Amy Schwartz, PhD, Human Centric Design Thought Leader, Health and
Consumer Solutions, Battelle
POC diagnostics is moving outside of the clinical setting and into the
everyday lives of consumers. This trend brings advantages in access,
convenience, and privacy along with challenges in designing for a user who is
not a medical professional in a clinical setting. We cannot depend on training
or instructions for successful product use, significantly raising the bar for
usability. A deep understanding of users and use environments is essential.
Sponsored by3:10 Improving the Performance and Connectivity of
Lateral Flow Assays for Diagnostic Applications
Karen Whiting, PhD, Global NPD Manager, NPD, BBI Group
Lateral flow immunoassays (LFI) are commonly used for many point-of-care
(POC) and diagnostic applications. A novel conjugation blocking service,
Morffi™ signal enhancement technology, has been shown to improve LFI test
line intensity and assay limit of detection. Rate of appearance of the test line
is also improved and the interpretation and subsequent sharing of test results
are supported from the POC by next-generation smartphone-enabled diagnostic
readers developed by Novarum DX.
3:40 Networking Coffee Break
4:15 Plenary Session
Please see page 3 for details
5:45 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall
with Poster Viewing
7:00 Close of Day
TUESDAY, AUGUST 21
7:15 am Registration
7:30 Problem Solving Breakout Sessions with Continental Breakfast
WHAT WILL THE FUTURE OF POC DEVICES LOOK LIKE?
8:30 Chairperson’s Remarks
James H. Nichols, PhD, DABCC, FACB, Professor, Pathology, Microbiology
and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT,
Vanderbilt University School of Medicine
Cambridge
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2018
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The 10th
important areas:
PLENARY KEYNOTES
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HOTEL & TRAVEL
SHORT COURSES
MOLECULAR BIOPSY
IMMUNO-ONCOLOGY
RAPID TESTING
PRECISION MEDICINE
BUSINESS

RAPID TESTING
Sponsored by8:35 Specimen Collection Devices for Infectious
Diseases Testing
Marek Smieja, MD, PhD, Professor, Pathology & Molecular Medicine,
McMaster University; Head, Microbiology, Hamilton Regional Laboratory Medicine
Program
Diagnostic tests for infectious diseases require appropriate specimens, like
throat, respiratory tract, urine, stool or skin, that could be collected by minimally-
trained staff or by the patient. Anatomically, collection devices need to be
efficient, safe, and yield reproducible results. We have developed and studied
collection devices for oral, throat, nasal, skin, and stool specimens, for antibody,
antigen, or nucleic-acid assays. Collection devices and transport media are
essential for high-quality infectious diseases testing, in laboratories and in
point-of-care.
9:05 New POCT Devices in the Near Future: What Will POCT Look Like?
William Clarke, PhD, MBA, DABCC, Associate Professor of Pathology, Johns
Hopkins University School of Medicine
In this lecture, we will discuss the current state of POCT and where developments
in technology will change the types of devices that are available. Specifically, we will
discuss gaps in existing technology and clinical care relative to existing devices, and
how research and technology development can meet those challenges. In addition,
we will discuss emerging technology that may become POCT products in the future.
9:35 Innovations in Phlebotomy: Beyond the Needle and Vacutainer for
Point-of-Care Sample Collection
James H. Nichols, PhD, DABCC, FAACC, Professor, Pathology, Microbiology and
Immunology; Medical Director, Clinical Chemistry and Point-of-Care Testing,
Vanderbilt University School of Medicine
Hospital acquired anemia from routine laboratory testing is a concern for critically
ill patients. POCT utilizes minimal sample volumes and has advantages over
modern laboratory automation equipment that cannot process, aliquot or sample
directly from pediatric microtainers. This presentation will identify innovations
in blood collection devices that are minimizing sample volumes, standardizing
phlebotomy processes and integrating POCT with sample collection.
10:05 Coffee Break in the Exhibit Hall with Poster Viewing
11:00 CLIA Regulations and Waived Testing
Karen W. Dyer, MT(ASCP), DLM, Director, Division of Clinical Laboratory
Improvement and Quality, Centers for Medicare & Medicaid Services
This presentation will provide background on the CLIA law and corresponding
regulations with focus on requirements for waived, moderate and high complexity
testing. Updated CLIA laboratory statistics will be presented as well as findings
from Certificate of Waiver educational surveys.
11:30 FDA Update on CLIA Waiver and Point-of-Care Testing
Peter Tobin, PhD, Chemist, Division of Program Operations and Management,
Office of In Vitro Diagnostics and Radiological Health, Center for Devices and
Radiological Health, Food and Drug Administration
This presentation will provide an update on recent developments, regulatory
pathways and study design recommendations for CLIA waiver, including how the
Dual 510(k) and CLIA Waiver by Application pathway can help speed the process
of bringing simple and accurate tests to CLIA-waived settings through valuable
time and study efficiencies. Study design recommendations for over-the-counter
tests and non-waived point-of-care tests will also be discussed.
Sponsored by12:00 pm Presentation to be Announced
Sponsored by
MICRO-ENGINEERING / MEDICAL / MANUFACTURING
12:15 Talk Title to be Announced
Jason Hayes, PhD, Head, Product Development, MiniFAB
Sponsored by12:30 Luncheon Talk Title to be Announced
Carmelo Volpe, PhD, Head, Clinical Diagnostics, Global Medical
Technology, Cambridge Consultants
1:00 Refreshment and Cookie Break in the Exhibit Hall with Poster Viewing
FULLY INTEGRATED CARTRIDGE-BASED POC DEVICES:
SAMPLE IN, RESULT OUT
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH
1:40 Naat Testing for Pathogens at Home or under a Tree
Paul Yager, PhD, Professor, Bioengineering, University of Washington
Our lab is pursuing development of low-cost rapid diagnostics to identify
the agents of infectious diseases; these tools must be appropriate for use in
low-resource settings. Under support of DARPA and the Bill & Melinda Gates
Foundation, we have been developing single-use, disposable, inexpensive
swab-to-result NAAT tests with human samples. These tests use isothermal
amplification of DNA or RNA, coupled to lateral flow detection.
2:10 Sample Preparation and Discretization Strategies for Portable
Multiplexed Nucleic Acid Diagnostics
Don L. DeVoe, PhD, Professor, Mechanical Engineering, University of Maryland,
College Park
Microfluidic diagnostics for use in near-patient settings demand the development
of simple, inexpensive, and robust methods for sample preparation, enabling
diagnostic targets to be isolated from blood with minimal instrumentation and
operator input. This talk will describe new methods for sample preparation using
thermoplastic microfluidics suitable for use at the point of care, combined with a
novel technique for passive sample discretization enabling effective multiplexed
analysis in the low-cost devices.
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2:40 Point-of-Care Infectious Disease Diagnosis via Inexpensive, User-
Friendly Nucleic Acid Testing Devices
Angelika Niemz, PhD, Arnold and Mabel Beckman Professor, Keck Graduate Institute
Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) cause sexually
transmitted infections that can lead to pelvic inflammatory disease, ectopic
pregnancy, or infertility in women. To enable diagnosis and treatment in the same
clinical encounter, our goal is to develop a CLIA-waived minimally instrumented
system for POC detection of CT/NG infections that combines the sensitivity of
central laboratory based nucleic acid amplification tests with the simplicity of
lateral flow tests.
Sponsored by3:05 Presentation to be Announced
3:35 Refreshment Break in the Exhibit Hall with Poster Viewing
HOW POCT IS ADDRESSING CHALLENGES WORLDWIDE:
NATURAL DISASTERS, INFECTIOUS DISEASES,
AND ZIKA OUTBREAKS
Gerald J. Kost, MD, MS, PhD, Director, Point-of-Care Testing Center for Teaching
and Research (POCT•CTR); Emeritus Professor, Pathology and Laboratory
Medicine, School of Medicine, University of California, Davis
4:25 Rethinking Strategies to Increase Resilience in Disasters:
Public Health Perspective of Technical and Community Solutions at
Points of Need
Ann M. Sakaguchi, MPH, PhD, Specialist, Director, Pacific Emergency Management,
Preparedness, Response, Information Network and Training Services (Pacific
EMPRINTS), National Disaster Life Support Regional Training Center-Pacific,
Anthropology, University of Hawaii, College of Social Sciences
This presentation sets the stage by: a) informing the audience that 2017 was the
costliest year in U.S. history for natural disasters, 2) alerting people that patients
with chronic and acute medical conditions often experience declining health
conditions at evacuation centers that can be further exacerbated by infectious
disease outbreaks, and 3) describing why rapid detection via POCT is an essential
technical and community solution at points of need.
4:55 Is Instrument-Free Molecular Detection of Highly Infectious
Diseases Possible?
Haim H. Bau, PhD, Professor, Mechanical Engineering and Applied Mechanics,
University of Pennsylvania
We describe a two-stage multiplexed isothermal assay and an inexpensive,
simple, rapid platform for molecular detection of pathogens at the point of care.
Our system isolates, concentrates, amplifies, detects, and quantifies target
nucleic acids and interfaces with a smartphone for sensing, data analysis, and
communications. We have successfully tested our assay with samples of Zika
virus patients in Panama.
5:25 Capabilities of Select Multiplex Point-of-Care Technologies
Hayden Huang, Senior Engineer, Center for Science, Technology and Engineering,
Government Accountability Office
We examined the performance characteristics of eight multiplex point-of-
care technologies, currently available or under development, for diagnoses of
infectious diseases. These technologies met or nearly met requirements of
two federal agencies. We found that key performance characteristics, such as
sensitivity and time to result, varied among the different technologies. These
findings raise questions about how end users can determine which technology is
most appropriate for their purposes.
5:55 Using Drones Instead of Couriers to Deliver Specimens to
Laboratories
Timothy Amukele, MD, PhD, Assistant Professor of Pathology, Johns Hopkins
University School of Medicine
Several recent reports demonstrate that medical samples can be transported by
drones without affecting the laboratory results. In addition, drones can go where
roads are non-existent or poor (rural areas, across bodies of water) as well as
outperform cars in traffic and in unusual road configurations e.g. two hospitals
separated by a highway. Has the time come to replace vehicle-based couriers with
drones? What are the real-life barriers to achieving this vision?
6:25 End of Enabling Point-of-Care Diagnostics
6:00 Dinner Short Course Registration
6:45 - 9:15 pm Recommended Dinner Short Course*
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Novel Technologies and Advances to Improve Clinical Outcomes
WEDNESDAY, AUGUST 22
7:45 am Registration and Morning Coffee
KEYNOTE SESSION: IMPROVING PATIENT OUTCOMES
THROUGH DIAGNOSTIC STEWARDSHIP
Charles Chiu, MD, PhD, Associate Professor, Laboratory Medicine and
Medicine/Infectious Diseases, Director, UCSF-Abbott Viral Diagnostics and
Discovery Center, Associate Director, UCSF Clinical Microbiology Laboratory,
UCSF School of Medicine
8:30 Diagnostic Stewardship: When Less Is More
Kevin Messacar, MD, Assistant Professor, Pediatrics, University of Colorado/
Children’s Hospital Colorado, Section of Infectious Diseases
Emerging diagnostic technologies for infectious diseases allow more
rapid, accurate identification of organisms, but can create confusion and
wasted resources if utilized in low-pre-test probability situations. Clinical
impact and cost-effectiveness are ranked highly by health care facilities
when considering uptake of new diagnostic technologies. This session will
outline key strategies of diagnostic stewardship to target testing using new
diagnostics towards high-yield patient populations, thereby maximizing
clinical impact and cost-effectiveness.
9:00 Diagnostic Stewardship for Clostridium difficile Testing
Christopher Polage, MD, MAS, Medical Director, Duke University Health
Systems Clinical Microbiology Laboratory; Associate Processor, Duke
University Medical Center
The inability of Clostridium difficile diagnostic tests to distinguish between
infection and colonization in patients makes proper patient selection before
testing of paramount importance. Diagnostic stewardship is a pre-analytic
intervention to minimize testing of patients with low likelihood of C. difficile
infection and reduce overdiagnosis caused by detection of C. difficile DNA
(or toxins) in patients without clinically significant C. difficile disease. The
rationale and approaches to diagnostic stewardship for C. difficile testing
will be discussed.
9:30 Implementing Outpatient Antimicrobial Stewardship in a
Community Pharmacy
Michael Klepser, PharmD, FCCP, Professor, Pharmacy Practice, Ferris State
University College of Pharmacy
Approximately 60%-80% of antibiotic use occurs in the outpatient setting,
and it has been estimated that more than half of this use is inappropriate.
The government has set a goal of reducing inappropriate outpatient
antibiotic use by 50%. Several investigators have described development
of physician /pharmacist collaborative care models that incorporate the
use of CLIA-waived point-of-care test to identify patients with various
infections. Data from these models reveal reduction in the inappropriate use
of antibiotics by >50% over historical controls for conditions such as acute
pharyngitis and influenza.
10:15 Sponsored Presentation (Opportunity Available)
11:15 Real-Time Whole-Genome Sequencing of MDROs for
Hospital Antimicrobial Stewardship and Infection Control
Guiqing (Hank) Wang, MD, PhD, Chief of Labs, Pathology and Clinical
Laboratories, Westchester Medical Center & New York Medical College
Real-time monitoring of multidrug-resistant organisms (MDROs) using
whole-genome sequencing (WGS) provides unprecedented resolution,
dynamic population genetics and precise actionable results against resistant
organisms in a healthcare setting. We started real-time WGS analysis
of ESKAPE organisms at a tertiary medical center in November 2016.
Integrated bacterial genomics from more than 2,000 unbiased MDRO strains
with other laboratory and clinical data have been used successfully to guide
hospital antimicrobial stewardship program and precision infection control
practice.
INNOVATIVE DIAGNOSTICS FOR MENINGITIS
AND ENCEPHALITIS
11:45 Molecular Approaches to Diagnosing Meningitis and Encephalitis
Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and Virology, Children’s
Hospital Los Angeles; Assistant Professor, Pathology and Laboratory Medicine,
Keck School of Medicine, University of Southern California
Meningitis and encephalitis are associated with significant morbidity and
mortality. Traditional approaches may be suboptimal to recover certain
pathogens. Emerging molecular technologies have shifted the diagnostic
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paradigm. This session will provide an overview of the current approaches to
the laboratory diagnosis of meningitis/encephalitis, with a focus on molecular
technologies. The clinical utility and potential impact on patient management and
outcome will also be discussed.
12:15 pm Clinical Outcome Benefits of Rapid Diagnosis of Meningitis
and Encephalitis
Nathan Ledeboer, PhD, Associate Professor of Pathology and Medical Director,
Medical College of Wisconsin
Syndromic panels were first FDA-approved for detection of respiratory pathogens
in 2008. Since then, other panels have been approved by the FDA and most
recently the FilmArray Meningitis/Encephalitis panel (BioFire, Salt Lake City, UT)
has become available. Several studies have reported both false-positive and
false-negative results with this test and all agree the cost is significant. Little has
been published on the outcome benefits this technology offers in management
of patient admission and antimicrobials. This session will explore the outcome
benefits of this technology when coupled with active antimicrobial stewardship.
Sponsored by12:45 Luncheon Presentation: Analytical and Clinical
Validation of a Microbial Cell-Free DNA Assay for
Pathogen Detection
Tim Blauwkamp, PhD, CSO, Karius
Describe data and methods from the analytical and clinical validations of a
quantitative next-generation sequencing (NGS) test for over 1000 different
pathogens performed by Karius. Discuss how a strategic panel of thirteen
reference microbes, in combination with extensive in silico testing, was used to
characterize all the traditional analytical performance characteristics (Lod/LoQ,
precision, interference, etc), as well as several new NGS-specific performance
characteristics, across the full spectrum of microbes assessed by the test.
1:15 Session Break
RAPID TESTING AND HOST RESPONSE
Christopher Polage, MD, MAS, Medical Director, Duke University Health Systems
Clinical Microbiology Laboratory; Associate Processor, Duke University Medical Center
1:50 Harnessing the Host Molecular Response to Health and Disease
Ephraim L. Tsalik, MD, MHS, PhD, Associate Professor of Medicine, Duke
University School of Medicine; Founder, Host Response, Inc.
Rapid and reliable identification of infection and pathogen class can mitigate
inappropriate antibiotic use and antimicrobial resistance. Measuring the
transcriptional and proteomic response of the host provides a powerful, unbiased
means of distinguishing disease states. However, this approach is only clinically
useful when signatures are developed for the right question and when measured
using rapid and reliable technology that delivers an answer at the point of need.
Host Response, Inc. has translated host response molecular signatures onto
diverse use-case dependent diagnostic platforms and is poised to transform
clinical management of infectious and non-infectious disease.
2:20 Rapid Molecular Diagnostics for Sepsis
Esther Babady, PhD, Director, Clinical Microbiology Operations, Memorial Sloan
Kettering Cancer Center
Sepsis remains a significant cause of morbidity and mortality in hospitalized
patients. The current gold standard, blood culture, is limited by a slow turn-
around time to results. Molecular methods for rapid diagnosis directly from blood
samples are emerging. Additionally, several options for rapid diagnosis from
positive blood cultures are now available. This presentation will review current
and future options for rapid diagnosis of sepsis and discuss utility in patient care.
Sponsored by2:50 Presentation to be Announced 
4:00 Clinical Needs and Current Challenges to Implementation of Point-
of-Care and Rapid Testing to Improve Antimicrobial Stewardship in the
Emergency Department
Larissa May, MD, MSPH, MSHS, Professor, Emergency Medicine; Director,
Emergency Department Antibiotic Stewardship, University of California Davis
There has been an explosion in the development and availability of rapid tests to
diagnose infectious diseases in acute care settings. Unfortunately, their promise
has not yet been realized. While there are significant opportunities to implement
these rapid tests for clinical use, their implementation must take into consideration
alignment with clinical operations and workflows and provide a better solution to
guide clinical decision making and improve patient safety and outcomes.
ADVANCES IN NGS FOR INFECTIOUS DISEASE DIAGNOSTICS
4:30 Metagenomic Sequencing for Infectious Disease Diagnosis and
Surveillance
Charles Chiu, MD, PhD, Associate Professor, Laboratory Medicine and Medicine/
Infectious Diseases, Director, UCSF-Abbott Viral Diagnostics and Discovery Center,
Associate Director, UCSF Clinical Microbiology Laboratory, UCSF School of Medicine
Metagenomic next-generation sequencing (mNGS) can enable detection of any
pathogen – virus, bacteria, fungus, or parasite – in a single test. Applications of
the mNGS approach include clinical diagnosis of infections (meningoencephalitis,
sepsis, and pneumonia) in hospitalized patients and public health surveillance of
emerging viruses. Efforts are underway to apply machine learning and deep learning
approaches to diagnose infections on the basis of host response RNA-seq data.
5:00 Pathogen Detection Standards for NGS and Metagenomics
Jason Kralj, PhD, Staff Scientist, Complex Microbial Systems Group, Biosystems
and Biomaterials Division, Material Measurements Laboratory, NIST
5:30 Networking Reception in the Exhibit Hall with Poster Viewing
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Senior Director, Health Policy and
Reimbursement, Hologic, Inc.
RAPID TESTING
6:30 Close of Day
THURSDAY, AUGUST 23
PANEL DISCUSSION: COMMERCIALIZATION AND
REGULATION OF NOVEL NGS DIAGNOSTICS FOR
INFECTIOUS DISEASE
Moderator: Heike Sichtig, PhD, Principal Investigator and Team Lead, Microbiology
Devices, Center for Devices (CDRH), FDA
8:25 Regulatory Perspective
Tamara Feldblyum, PhD, Branch Chief, Division of Microbiology Devices, Center for
Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological
Health, U.S. Food and Drug Administration
8:35 Assay Development Perspective
Timothy D. Minogue, PhD, Chief, Molecular Diagnostics Department, Diagnostic
Systems Division, USAMRIID
8:45 Clinical Implementation Perspective
Gary W. Procop, MD, Director, Molecular Microbiology, Parasitology, Virology
Laboratories; Co-Chair, Enterprise Laboratory Stewardship Committee, Medical
Operations; Processor of Pathology, Cleveland Clinic Lerner College of Medicine,
Cleveland Clinic
8:55 Bioinformatics Perspective
Tom Slezak, Distinguished Member of the Technical Staff, Global Security
Program, Lawrence Livermore National Lab
9:05 PANEL DISCUSSION
• What is the status of quantitative NGS as it is being used in the clinic?
• What is the role of bioinformatics?
• How to mitigate the issue of long, expensive assays
• Point-of-care
• Antimicrobial resistance
9:30 Data-Driven View of Payer Prior Authorization Programs Sponsored by
Walt Williams, Director, Revenue Optimization & Strategy, Revenue
Cycle Services, Quadax
Focusing less on theory and more on reality, we will discuss some of the evolving
trends found in the claims adjudication and revenue cycle process for molecular
pathology claims exposed to the prominent payer prior authorization programs.
Presented from Quadax’s unique perspective as one of the leading RCM providers
for laboratories, we will explore the programs’ real impact on claims processing
timelines, receipts, payment timeliness, denial trends and more.
12:45 pm Luncheon Presentation (Sponsorship Opportunity Available) or
Enjoy Lunch on Your Own
1:15 Close of Molecular Diagnostics for Infectious Disease
Recommended Dinner Short Course*
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CAMBRIDGE HEALTHTECH INSTITUTE’S 2ND
THURSDAY, AUGUST 23
1:15 Ice Cream and Cookie Break in the Exhibit Hall with Poster Viewing
MINIATURIZATION AND SMART PHONES
Sidhant Jena, MBA, Co-Founder & CEO, Jana Care
2:05 KEYNOTE PRESENTATION: Detecting Proteins at High
Sensitivity on a Lateral Flow Test
Paul Yager, PhD, Professor, Department of Bioengineering, University of
Washington
Our lab is pursuing development of low-cost rapid diagnostics to identify
the agents of infectious diseases; these tools must be appropriate for use
in low-resource settings. Under support of NIH and DTRA, we have been
developing single-use, disposable, inexpensive sensitive lateral flow tests for
use with human samples. These tests use novel protein binders developed in
the laboratory of Prof. David Baker.
2:50 Microfluidics for Point-of-Care Testing
James Landers, PhD, Commonwealth Professor of Chemistry, Professor of
Mechanical Engineering, Associate Professor of Pathology, University of Virginia
Enumeration of blood cells is an integral metric for evaluating patient health and can
be used to screen for a wide range of diseases and conditions. Conventional methods
rely on large, expensive, and complicated instrumentation that requires trained
technicians and is not amenable to point-of-care analysis. This work demonstrates
the use of a multiplexed, bead-based assay for both rapid white blood cell (WBC)
count screening and accurate, multiplexed WBC counts for point-of-care analysis.
4:05 Networking Refreshment Break
4:30 Point-Of-Care (POC) Methods for the Chronic Diseases
Sidhant Jena, MBA, Co-Founder & CEO, Jana Care
JanaCare has developed paper-based test strips for biomarkers that can be useful for
screening or home monitoring. We have also developed a way to turn your smartphone
into a diagnostic platform using the Aina device to read paper strips of all kinds.
5:00 Application of Microfluidics in Diagnostic Devices – Challenges
and Opportunities
Manish Deshpande, PhD, Vice President, R&D, Point of Care BU, Siemens Healthcare
Microfluidics has long held considerable promise in its potential to minimize cost,
sample volume and increase throughput in diagnostics, especially at the point-
of-care. Traditional microfluidics has shown some promise, but is not without
considerable challenge in reduction to practice for global commercial devices.
This presentation will focus on both the opportunities and difficulties in current
practice and future.
5:30 Miniaturized Means towards Huge Cancer Profiling Ends through
Nanotechnologies at the Point of Care
Cesar Castro, MD, Director, Cancer Program, MGH Center for Systems Biology,
Massachusetts General Hospital, Harvard Medical School
Both tumor heterogeneity and the need for dynamic tracking of treatment
response limit the full potential of precision oncology. Invasive core biopsies for
extensive sampling of tumors do not permit serial analyses to assist with “Go /
No-Go” decisions.
6:00 Close of Day
6:30 - 9:00 pm Recommended Dinner Short Course(s)*
FRIDAY, AUGUST 24
NANOTECHNOLOGY APPLICATIONS
Joshua Smith, PhD, Research Staff Member, Translational Systems Biology and
Nanobiotechnology, IBM T.J. Watson Research Center
8:30 High-Throughput Liquid Biopsy Processing and Validation Using
NanoDLD-Based Microfluidic Technology
Joshua Smith, PhD, Research Staff Member, Translational Systems Biology and
Nanobiotechnology, IBM T.J. Watson Research Center
Liquid biopsies are a promising avenue that may augment more traditional
screening methods for early-stage disease detection. For clinical implementation,
technologies are needed that can rapidly isolate, enrich, and purify analytes. Here,
I will highlight our latest advancements in liquid biopsy processing using nanoDLD
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with sample throughput rates > 1mL/hr and downstream analysis and validation
of circulating biomarkers, including exosomes and DNA.
9:00 Nano-Plasmonic Sensing Technology for Tumor-Derived
Exosome Detection
Hyungsoon Im, PhD, Assistant Professor, Center for Systems Biology,
Massachusetts General Hospital
This presentation will review a recent progress of nPLEX (nano-plasmonic
exosome) technology. The sensor is based on transmission surface plasmon
resonance (SPR) through periodic nanohole arrays. Target-specific exosome
binding to the array via affinity ligands causes SPR signal changes, which enable
sensitive and fast detection of exosomes. We applied the nPLEX system to detect
exosomes collected from ovarian and pancreatic cancer patients.
9:30 Magnetic Levitation System for Detection of Extracellular Vesicles
Ionita Ghiran, MD, Associate Professor of Medicine, Beth Israel Deaconess Medical
Center
We herein describe a novel application of the magnetic levitation method, which
can specifically detect cell membrane-bound and soluble antigens by identifying
and quantifying discreet changes in levitation height of two sets of distinct
density beads, coated with capture and detection antibodies.
REIMBURSEMENT FOR POCT
11:00 PANEL DISCUSSION: The Value Proposition of Point-Of-Care Testing
Moderators: John Warren, Senior Director, McDermottPlus Consulting
Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott
Laboratories
Join a panel of experts from payers, providers and patients discussing the value
and future of point-of-care testing. During this informative panel discussion, listen
to these leaders as they discuss:
• How point-of-care testing adds value to the patient experience
• What role point-of-care testing plays in a value-based payment system
• What new advancements in point-of-care testing are on the horizon
Panelists: Joseph Rubino, PhD, Senior Reimbursement Specialist, Cepheid
Diana R. Hernandez, PhD, Clinical Microbiology Research Director, Center for
Infectious Diseases Diagnostics & Research, Geisinger
Rachael Evans, CMO, Henry J. Austin Health Center, Family Medicine
12:00 pm Sponsored Presentation (Opportunity Available)
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or
1:00 Session Break
MICROFLUIDIC PLATFORMS FOR SINGLE CELL ANALYSIS
Xiaodong Xiao, PhD, Director, Biologics Discovery, Biologics Lead Discovery,
Bristol-Myers Squibb
1:35 Applications of Microfluidic and NGS Platforms for Efficient
Biotherapeutics Development and Diagnostics
Xiaodong Xiao, PhD, Director, Biologics Discovery, Biologics Lead Discovery,
Bristol-Myers Squibb
The combined strength of microfluidic and NGS can provide insight into biological
activities as detailed as within a single cell, and as massive as millions of cells.
We describe here an approach through which millions of B cells are encapsulated
in micro-droplets, within which antibody genes are assembled into an scFv
format. A phage display library can then be generated, and antibodies discovered.
We designed a novel NGS approach to sequence the full length Vh/Vl sequences
in the library in paired fashion. These strategies can be applied for biotherapeutics
development, diagnostics and biomarker discovery.
2:05 Ultralow-Input Microfluidic Assays for Epigenomic Analysis
Chang Lu, PhD, Fred W. Bull Professor, Chemical Engineering, Virginia Tech
Epigenome dictates turning on and off genes in a highly dynamic fashion during
normal development and diseases, forming another layer of regulation on top of
gene sequence. In this talk, I will discuss our efforts on using microfluidics as a
versatile platform for profiling epigenomes based on a low number of cells in the
context of precision medicine.
2:35 A Microfluidic Platform for High-Throughput Micro-RNA Profiling
of Single Cells
Suman Bose, PhD, Postdoctoral Fellow, Koch Institute for Integrative Cancer
Research, Massachusetts Institute of Technology
MicroRNAs are non-coding RNAs that function in gene regulation and are a robust
biomarker for many diseases. In this talk, I will present a microfluidic platform
that enables enrichment of miRNA from single cells and processes them for
sequencing. Single cells are lysed within droplets and a magnetic tweezer is
used to enrich for Ago2-bound miRNA, which are then barcoded and processed
for sequencing. Finally, I will discuss the application of this in single cell miRNA
profiling of mouse ES cells.
3:05 End of Summit
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Advances in sequencing technologies and
data analytics has brought about a new era
in understanding and interpreting cells, DNA,
RNA, and exosomes, which in turn has rapidly
advanced our capabilities in diagnostics and
therapeutics. The Molecular Biopsy stream at
Next Generation Dx Summit gathers leaders,
researchers, and experts in cell and DNA
capture and microdissection, sequencing,
data analysis, and interpretation to explore
applications of molecular biopsy in clinical
applications, their impact on the healthcare
system, and future directions for diagnostic
assay research and development.
2018 MOLECULAR BIOPSY CONFERENCE PROGRAMS
AUGUST 20-21
Circulating Tumor Cells
AUGUST 22-23
Clinical Application of Cell-Free DNA
AUGUST 23-24
A

MOLECULAR BIOPSY
CAMBRIDGE HEALTHTECH INSTITUTE’S 3RD
Understanding Their Biology and Clinical Significance
Reimbursement
MONDAY, AUGUST 20
12:00 pm Main Conference Registration
EMERGING TECHNOLOGY FOR CTC DETECTION,
ISOLATION AND ANALYSIS
Sunitha Nagrath, PhD, Associate Professor, Chemical Engineering, University of Michigan
1:40 New Tools for Liquid Biopsies: Microfluidics for the Efficient
Isolation of Circulating Leukemia and Myeloma Cells
Steven A. Soper, PhD, Foundation Distinguished Professor, Chemistry, Mechanical
Engineering, Cancer Biology, and Bioengineering, University of Kansas
We will discuss our work in negating the need for bone marrow biopsies by using
liquid biopsies for leukemia and multiple myeloma by selecting circulating cells
from whole blood to manage these diseases. Acute myeloid leukemia (AML)
and pediatric acute lymphoblastic leukemia (ALL) minimum residual disease
states were monitored for signs of recurrence using circulating leukemia cells.
For multiple myeloma, circulating cells were used to stage patients (MGUS,
smoldering or active myeloma).
2:10 Capture, Interrogation, Imaging, Automated Analysis and Culture
of CTCs: Strategies for the Development of a Transformative Tool to
Understand Cancer
Richard J. Cote, MD, FRCPath, FCAP, Professor, Joseph R. Coulter Jr. Chair,
Pathology & Laboratory Medicine; Professor, Biochemistry and Molecular Biology;
Chief of Pathology, Jackson Memorial Hospital
Circulating tumor cells (CTC) are important clinical biomarkers for cancer
diagnosis, prognosis and target identification. Recently, we have described the
presence of circulating Cancer Associated Fibroblasts (cCAF), which may have
great importance. We will discuss integrated platforms for capture and novel
imaging of CTC/cCAF, efforts to automate the analysis of CTC/cCAF images, and
live CTC capture, which could lead to expansion, propagation, and creation of an
important new biospecimen for cancer discovery.
2:40 Microfluidic Labyrinth Chip for Monitoring Cancer Stem Cells
We developed a novel chip containing fluid channels that uses hydrodynamic
maze to separate circulating tumor cells into an analytic stream after sending
blood samples through the chip. We are currently testing this microfluidic
Labyrinth chip in a breast cancer clinical trial.
5:45 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with
Poster Viewing
7:00 Close of Day
TUESDAY, AUGUST 21
EMERGING TECHNOLOGY FOR CTC DETECTION,
ISOLATION AND ANALYSIS (CONT.)
8:35 Microfluidics and CTCs: Detection, Metastatic Insights and
Drug Testing
Siva A. Vanapalli, PhD, Professor, Chemical Engineering, Texas Tech University
Recent progress in cancer research has shown that circulating tumor cells (CTCs)
can provide significant diagnostic and prognostic value. In this presentation, I will
discuss advances we have made in our laboratory on microfluidic approaches
for (i) label-free detection of tumor cells in blood, (ii) evaluating deformation and
survival of CTCs to physical forces in circulation, and (iii) testing drugs in single
tumor cells and clusters.
9:05 Whole Blood Stabilization for the Microfluidic Isolation and
Molecular Characterization of Circulating Tumor Cells
Shannon N. Tessier, PhD, Instructor, Center for Engineering in Medicine,
Cambridge
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Department of Surgery, Massachusetts General Hospital, Harvard Medical School
Peripheral blood is the most frequently accessed tissue in the clinic with broad
clinical and scientific importance. The field of blood-based diagnostics suffers
from lack of effective stabilization protocols. We present our efforts on prolonging
the length of time whole blood can be preserved, using multi-pronged approach
with a path to clinical translation. We achieved 72 hours of blood stabilization for
the isolation and RNA preservation of circulating tumor cells.
CTCS AND THE IMMUNE SYSTEM
9:35 Circulating Tumor Cell and Their Metabolites: Moving Biological
Insights into Detection
Zigang Dong, PhD, Executive Director & Professor, Cellular & Molecular Biology,
The Hormel Institute, University of Minnesota
Circulating tumor cells (CTCs) and tumor cell metabolites have shown promising
potential as liquid biopsies that facilitate early detection, prognosis, therapeutic
target selection and monitoring treatment response. Several methodologies for CTC
characterization and their metabolites detection have been developed over the past
few years. I will summarize recent advances in our studies of CTC biology and tumor
cell metabolites, especially postglanding in cancer detection, prevention, and therapy.
11:00 KEYNOTE PRESENTATION: Dissecting Liquid Biopsy in MBC:
CTCs, ctDNA and CAMLs to Evaluate Innate Immunity
Massimo Cristofanilli, MD, FACP, Professor, Medicine; Associate Director,
Translational Research and Precision Medicine; Director, OncoSET Precision
Medicine Program, Medicine-Hematology and Oncology, Robert H. Lurie
Comprehensive Cancer Center, Feinberg School of Medicine,
Northwestern University
The detection of circulating tumor cells (CTCs) and clusters in MBC patients
are prognostic and predict higher rate of metastatic spread. Furthermore, CTCs
characterization combined with circulating cell-free DNA (ctDNA) provides a
more comprehensive understanding of disease heterogeneity and advanced the
possibility for performing a longitudinal molecular monitoring. Most recently, the
discovery of CAMLs expanded the ability of blood-based diagnostics.
CLINICAL OUTCOME CORRELATION WITH CTC DETECTION
Min Yu, MD, PhD, Assistant Professor, Stem Cell Biology and Regenerative
Medicine Member, Norris Comprehensive Cancer Center, Keck School of Medicine,
University of Southern California
11:30 Using Liquid Biopsy to Detect Diverse Mechanisms of
Resistance to Endocrine Therapy in Hormone-Receptor Positive
Metastatic Breast Cancer
Costanza Paoletti, MD, Research Investigator, Internal Medicine, Hematology
Oncology, University of Michigan Comprehensive Cancer Center
Liquid biopsies have allowed evaluation of cancer using serial, non-invasive
approaches. Through circulating tumor cells’ assessment (enumeration,
phenotyping, and next-generation sequencing), we were able to detect diverse
mechanisms of resistance to endocrine therapy in hormone-receptor positive
metastatic breast cancer. Overall, our data suggest that liquid biopsies may allow
a better understanding of the bases of resistance to endocrine therapies revealing
opportunity for precision medicine.
Sponsored by
12:00 pm Presentation to be Announced
12:30 Luncheon Presentation (Sponsorship Opportunity
Available) or Enjoy Lunch on Your Own
1:00 Refreshment and Cookie Break in the Exhibit Hall with Poster Viewing
CLINICAL OUTCOME CORRELATION WITH CTC
DETECTION (CONT.)
1:35 RNA-based Circulating Tumor Cell Signatures for Precision
Cancer Medicine
David T. Miyamoto, MD, PhD, Assistant Professor, Radiation Oncology, Harvard
Medical School, Center for Cancer Research, Massachusetts General Hospital
Circulating tumor cells (CTCs) are a form of “liquid biopsy” that can be performed
non-invasively to predict and monitor treatment responses. In contrast to circulating
tumor DNA (ctDNA), CTCs enable tumor RNA expression profiling, an analysis not
possible with ctDNA. Microfluidic enrichment of CTCs followed by application of
RNA-based digital PCR enables the high-throughput and highly specific detection
of CTC molecular signatures in several cancer types. These CTC signatures can
predict therapeutic responses and may enable the early detection of invasive
cancers, thus guiding the precision management of cancer patients.
2:05 PANEL DISCUSSION: Defining Tumor Associated Circulating Cells -
Moving toward Standardization and Clinical Utility
Moderator: Lynn R. Sorbara, PhD, Program Director, Cancer Biomarker Research
Group, National Cancer Institute
Panelists:
Richard J. Cote, MD, FRCPath, FCAP, Professor, Joseph R. Coulter Jr. Chair,
Pathology & Laboratory Medicine; Professor, Biochemistry and Molecular Biology;
Chief of Pathology, Jackson Memorial Hospital
Massimo Cristofanilli, MD, FACP, Professor, Medicine; Associate Director, Translational
Research and Precision Medicine; Director, OncoSET Precision Medicine Program,
Medicine-Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center,
Feinberg School of Medicine, Northwestern University, Chicago
MOLECULAR BIOPSY
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Youli Zu, MD, PhD, Professor and Endowed Chair in Pathology; Chief,
Hematopathology Section; Director, Cancer Pathology Research Lab, Pathology
and Genomic Medicine, Houston Methodist Hospital
• Are we all speaking the same language? What is a CTC?
• What are the various types of tumor-associated circulating cells and tumor-
associated circulating targets?
• What information can we glean from each cell type?
• What are the barriers for propagation and culture of CTC?
• What advances are needed to make the ease of CTC capture, analysis and
interpretation easier, more reliable and more user-friendly?
• How can we address the challenge of clinical correlation with the detection of
various tumor-associated circulating cells and other circulating targets?
• What strategies can we use to come to consensus on quality control and
standardization for CTC characterization and analysis?
Sponsored by3:05 Circulating Tumor Cells: From the Research Bench to
the CLIA Lab, a True Story
Madeline I. Repollet, PhD, CT(ASCP)CM, Head, Clinical Laboratories
Operations and Services, Menarini Silicon Biosystems Labs
CTC EXPANSION
Sponsored by
4:25 Presentation to be Announced
4:55 Microfluidic Isolation and Expansion of Patient-Derived Circulating
Tumor Cells from Liquid Biopsies
Chwee Teck Lim, PhD, Professor, Mechanobiology Institute, National University of
Singapore
We recently developed a simple but unique microfluidics-based culture
approach that requires minimal preprocessing (30 min) and does not require
prior enrichment of CTCs or depend on the use of growth factor supplements.
The approach capitalizes on co-culture of immune cells from the same patient
blood sample within specially designed microwells that promote CTC cluster
formation within 2 weeks, with an overall cluster formation success rate of
50%. The described microfluidics system can be operated with a single syringe
pump to introduce drug compounds (which takes 6 min), followed by incubation
of the CTC clusters for 48 h before analysis. In addition to its applications in
biomedical research, the rapid readout of our platform will enable clinicians to
assess or predict a patient’s response to various therapeutic strategies to enable
personalized or precision therapy.
5:25 Ex vivo Cultured CTCs Inform Mechanisms of Breast Cancer Metastasis
Circulating tumor cells (CTCs) are expected to contain metastasis-initiating
cells that can shed light on the mechanisms of cancer metastasis. However,
due to limited patient-derived material, the metastatic capability of CTCs has
yet to be proved. Using our recently established patient-derived CTC lines, we
now demonstrate that different patient CTC lines have distinct metastatic tissue
tropisms in immunodeficient mice and identified associated pathways to specific
organs via RNA-seq and ATAC-seq analysis.
5:55 USP7 Targeting Identifies a Metastasis-Competent State within
Bone Marrow-Resident Melanoma CTCs
Dario Marchetti, PhD, Director, Biomarker Program, Methodist Hospital, Biomarker
Program, Houston Methodist Research Institute
We used a negative depletion strategy to isolate Lin-neg cell population from the
blood of metastatic melanoma patients. Biomarker gene expression profiling
identified the presence of a discrete population of putative CTCs in Lin-neg cells,
possessing upregulated gene transcripts implicated in cell survival and pro-
development functions. We implanted Lin-neg/CTC-enriched population in NOD/SCID
mice (CTC-derived xenografts or CDXs) and discovered divergent transcriptomic
signatures of CDX-isolated bone marrow-resident tumor cells (BMRTCs) vs blood
CTCs. Pathway analyses pointed to protein ubiquitination as the significantly altered
canonical pathway associated with BMRTCs. The selective inhibition of USP7, a
key deubiquinating enzyme of this pathway, lead to a significant reduction of CDX
organ micro-metastasis. Together, these results provide first-time evidence of a
functionally relevant CTC phenotype within patient-derived, BM-resident melanoma
CTCs contributing to disease progression; and support further investigation of USP7
inhibitors in new strategies to prevent overt or undetectable metastasis.
6:25 End of Circulating Tumor Cells
SC8: Commercialization Boot Camp: Manual for Success in
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Advancing Non-Invasive Diagnostics
Reimbursement
WEDNESDAY, AUGUST 22
TREATMENT RESPONSE MONITORING
Abhijit Patel, MD, PhD, Associate Professor, Yale University School of Medicine
8:30 Role of cfDNA in Immunotherapy
Shumei Kato, MD, Assistant Clinical Professor, Hematology & Oncology, Center for
Personalized Cancer Therapy, UC San Diego Moores Cancer Center
Although immunotherapies can demonstrate salutary anti-cancer effect in a portion
of patients, unfortunately not all patients benefit. Even in the presence of favorable
response markers (e.g. positive PD-L1, MSI-high, high tumor mutation burden), the
response rate is about 50-60%. Thus, further evaluation of immune biomarkers are
required. We will present ctDNA (cell-free, circulating tumor DNA) as a potential tool
to monitor the response from immunotherapy in cancer patients.
9:00 Tracking Immunotherapy Efficacy via ctDNA
Abhijit Patel, MD, PhD, Associate Professor, Therapeutic Radiology, Yale University
School of Medicine
Immunotherapies are known to produce slow changes in radiographic tumor
size. We hypothesized that real-time measurement of tumor cell death via ctDNA
could enable earlier assessment of immunotherapy response in patients with
lung cancer. This presentation will summarize our findings, showing that down-
trending ctDNA levels correlate strongly with radiographic response and predict a
longer duration of treatment benefit, as well as superior progression-free survival
and overall survival.
9:30 The 4P’s of Liquid Biopsy: Predictive, Preventive, Personalized and
Participatory
Nefize Sertac Kip, MD, PhD, Associate Professor, Molecular Oncology, Icahn
School of Medicine, Mount Sinai
Multiple liquid biopsy assays are currently available for the detection of somatic
mutations, with an analytical sensitivity of <0.1%, to assess minimal residual
disease, detect resistance mutations, predict response to therapy, prognosticate
disease, and determine not only late but also early stages of malignancy, with
the ultimate goal of cancer prevention. Due to the ease of obtaining liquid biopsy
specimens, patients are expected to participate more in such studies and thus
help generate bigger data sets to better understand not only the individual’s
tumor behavior with impact on precision medicine, but also improve population
outcomes in cancer, with clinical and financial gains.
EARLY DETECTION
11:15 KEYNOTE PRESENTATION: Non-Invasive Early Detection of Cancer
Nickolas Papadopoulos, PhD, Professor, Oncology and Pathology; Director,
Translational Genetics, Ludwig Center for Cancer Genetics & Therapeutics,
Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins Institutions
Earlier detection of cancer is important to reducing cancer deaths. We
developed CancerSEEK, a blood test that can detect eight common cancer
types through assessment of the levels of circulating proteins and mutations in
cell-free DNA. Furthermore, CancerSEEK localized the cancer to a small number
of anatomic sites.
11:45 Circulating Tumor DNA Methylation Markers for Diagnosis and
Prognosis of Hepatocellular Carcinoma
Kang Zhang, MD, PhD, Professor, Human Genetics and Nano-Engineering; Founding
Director, Institute for Genomic Medicine, University of California, San Diego
We identified an HCC-specific methylation marker by comparing HCC tissue and
normal blood leukocytes and showed that methylation profiles of HCC tumor DNA
and matched plasma ctDNA are highly correlated. We constructed a diagnostic
prediction model with high diagnostic specificity and sensitivity and was highly
correlated with tumor burden, treatment response, and stage. Additionally, we
constructed a prognostic prediction model that effectively predicted prognosis
and survival.
12:15 pm Circulating Tumor DNA Analysis for Personalized Cancer
Detection and Monitoring
Maximilian Diehn, MD, PhD, Assistant Professor, Radiation Oncology, Stanford Cancer
Institute, Institute for Stem Cell Biology & Regenerative Medicine, Stanford University
Circulating tumor DNA (ctDNA) represents a promising biomarker for sensitive,
specific, and dynamic detection of disease burden in cancer patients. Mutations
in tumor-derived DNA represent ideal potential biomarkers since they are highly
specific to tumor cells and involved in disease pathogenesis. However, even in
advanced cancer patients concentrations of ctDNA are often low and difficult
to detect. We have developed a novel, ultra-sensitive and specific method for
detection of circulatingtumor DNA called Cancer Personalized Profiling by Deep
Sequencing (CAPP-Seq). This method was developed specifically for detection
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of ctDNA in non-small cell lung cancerpatients, although it is broadly applicable
to other cancer types. In this presentation, I will describe our recent work on
applications of ctDNA analysis in a variety of clinical settings.
12:45 Luncheon Presentation (Sponsorship Opportunity Available) or
1:15 Session Break
Maximilian Diehn, MD, PhD, Assistant Professor, Radiation Oncology, Stanford Cancer
Institute, Institute for Stem Cell Biology & Regenerative Medicine, Stanford University
1:50 The Early Detection of Pancreatic Cancer: What Will It Take to
Diagnose and Treat Curable Pancreatic Neoplasia?
Anne Marie O’Broin-Lennon, MD, PhD, Director, Multidisciplinary Pancreatic Cyst
Program; Associate Professor of Medicine, Johns Hopkins University
2:20 Serum MicroRNA ‘Signatures’ in Early Detection of Ovarian Cancer
Dipanjan Chowdhury, PhD, Chief of the Division of Radiation and Genomic Stability,
Department of Radiation Oncology, Dana-Farber Cancer Institute; Associate Professor,
Harvard Medical School; Associate Member, Broad Institute of Harvard & MIT
Sponsored by
2:50 Liquid Biopsy based on Flow Cytometry and Artificial
Intelligence to Detect the Existence of a Solid Tumor
Amit Kumar, PhD, President and CEO, Anixa Diagnostics
We utilize flow cytometry of leukocytes with artificial intelligence to perform
early detection of cancers. By monitoring the host immune system we are able
to distinguish tumor-bearing individuals from healthy donors. Sensitivities and
specificities are greater than 90% each. This is a simple, inexpensive, patented
technology for liquid biopsy.
TREATMENT RESPONSE MONITORING AND MINIMAL
RESIDUAL DISEASE DETECTION
Scott Kopetz, MD, PhD, FACP, Associate Professor, Gastrointestinal Medical
Oncology, University of Texas MD Anderson Cancer Center
4:00 Circulating Tumor DNA as Prognostic and Predictive Marker in
Colon, Lung and Pancreatic Cancer
Valerie Taly, PhD, CNRS Research Director (Dr2), Group Leader, Co-Director Ediag
Platform, UFR Des Sciences Fondamentales Et Biomedicales, France
Recent technological and methodological developments such as droplet based
digital PCR and optimized NGS have allowed the highly sensitive and quantitative
detection of rare genetic and epigenetic events. We will present applications of
these technologies to the highly sensitive and precise detection of circulating
tumor DNA (ctDNA). In particular, we will illustrate the pertinence of ctDNA as a
prognostic and predictive marker in colon, lung and pancreatic cancers.
4:30 Monitoring Cancer through the Blood
Cloud Paweletz, PhD, Head, Translational Research Laboratory, Belfer Center for
Applied Cancer Science, Dana Farber Cancer Institute
Noninvasive assessment of tumor genotype using cell free DNA (cfDNA)
represents an emerging technology that can overcome many of the current
challenges in personalizing NSCLC care. There are a variety of assays available,
some focused and rapid and others broad but more cumbersome (e.g. NGS).
Indeed, some of these cfDNA genotyping technologies are being offered
commercially for clinical use, however appropriate clinical application is uncertain
and clinical validation efforts have been inconsistent. Here we present our
institutional experiences implementing liquid biopsies into NSCLC care.
5:00 Treatment Response Monitoring and Minimal Residual Disease
Detection on Adjuvant Study Design Considerations Utilizing Minimal
Residual Disease
Scott Kopetz, MD, PhD, Associate Professor, Gastrointestinal Medical Oncology,
University of Texas MD Anderson Cancer Center
Circulating tumor DNA (cfDNA) has the potential to identify patients with residual
disease despite attempted curative resection with very high specificity. This
opens possibilities for novel “adjuvant” study designs.
5:30 Networking Reception in the Exhibit Hall with Poster Viewing
6:30 Close of Day
THURSDAY, AUGUST 23
CLONAL HEMATOPOEISIS
Luis A. Diaz, MD, Head, Solid Tumor Oncology, Memorial Sloan Kettering Cancer
Center, Conference Chairman
8:30 Clonal Hematopoiesis Is Common in Cancer Patients and Can
Confound Clinical Genomic Profiling
Ahmet Zehir, PhD, Director, Clinical Bioinformatics, Assistant Attending, Pathology,
Memorial Sloan Kettering Cancer Center
Clonal hematopoiesis (CH) is the somatic acquisition of genomic alterations
in the hematopoietic stem cells/progenitors. CH is a common occurrence in
advanced cancer patients that is strongly associated with aging, smoking and
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with radiation therapy. If unchecked, CH related genomic alterations can also
confound genomic profiling of cancer patients in various settings. Here, I will
describe our experience related to CH, in a prospective sequencing cohort at
Memorial Sloan Kettering Cancer Center.
9:00 The Impact of Oncologic Therapy on the Risk of Clonal
Hematopoiesis and Subsequent Hematologic Malignancy
Kelly Bolton, MD, Hematology-Oncology Fellow, Department of Medicine, Memorial
Sloan Kettering
We used blood sequencing data from 17,000 solid tumor patients at MSKCC to
identify clonal hematopoiesis. We show that exposure to radiation therapy and
certain chemotherapy agents are associated with increased rates of CH which is,
in turn, a major risk factor for therapy-related myeloid neoplasms. In 300 patients
with CH with serial samples, we show that ongoing chemotherapy and radiation
therapy influence clonal dynamics of CH.
1:15 Close of Clinical Application of Cell-Free DNA
SC11: Single-Cell RNA-Seq: Differential Expression Analysis and
Quality Control
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Scientific Project Leadership, Precision Medicine and Diagnostics, R&D ImmunoInflammation, GSK
Cambridge
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CAMBRIDGE HEALTHTECH INSTITUTE’S INAUGURAL | AUGUST 23-24, 2018
Profiling to Interpretation for Emerging Diagnostic Applications
THURSDAY, AUGUST 23
12:45 pm Luncheon Presentation (Sponsorship Opportunity Available)
or Enjoy Lunch on Your Own
1:15 Ice Cream and Cookie Break in the Exhibit Hall with Poster Viewing
SINGLE CELL OMICS AND CELL HETEROGENEITY
Joshy George, PhD, Associate Director, Computational Sciences, Jackson
Laboratory for Genomic Medicine
2:05 Dissecting Adult and Pediatric Gliomas by Single-Cell Genomics
Mario Suva, MD, PhD, Assistant Professor, Pathology, Massachusetts General
Hospital
I will discuss single-cell RNA-sequencing analysis of clinical samples of
glioblastoma, IDH-mutant gliomas and pediatric histone-mutant gliomas,
focusing both on malignant cells and on the tumor micro-environment.
2:30 Sparse Profiling of Single-Cell Genomes for Diagnosis and
Detection of Tumors
Alexander Krasnitz, PhD, Associate Professor, Simons Center for Quantitative
Biology, Cold Spring Harbor Laboratory
Nuclear DNA copy number variation (CNV) profiles of individual cells can be
determined, accurately and efficiently, by next-generation sequencing at very
low coverage. Given the ubiquity of genome-wide somatic CNV in cancer,
such profiling, applied to cells harvested from tissue biopsies, is a powerful
diagnostic tool which facilitates reconstruction of clonal cell populations in a
tumor and evaluation of its invasive potential. Sparse single-nucleus sequencing,
supplemented by leukocyte depletion, can also provide a basis for sensitive,
specific and affordable early detection of cancer signatures in blood of
asymptomatic individuals.
2:55 Classical Blood Monocytes May Predict Response to
Anti-PD-i Immunotherapy
Carsten Krieg, PhD, Assistant Professor, Microbiology & Immunology, Medical
University of South Carolina
Anti-PD-i therapy is clinically effective against a wide range of cancers, but only
a fraction of patients responds. Therefore, biomarkers to predict response are
desperately needed. We combined high-dimensional single cell mass cytometry
and a bioinformatics pipeline for the in-depth characterization of immune cells in
the peripheral blood of metastatic melanoma patients before and after 3 months
of anti-PD-i immunotherapy. A strong predictor of progression free and overall
survival in response to anti-PD-i was the frequency of CD14tCDi6.HLADRb1
classical monocytes, and we propose this as a novel predictive biomarker for
therapy decisions in the clinic.
3:20 Single-Cell Proteomics by Mass Spectrometry: From Embryo to
Nervous System
Aparna B. Baxi, Graduate Student, Chemistry & Biochemistry, Anatomy and
Regenerative Biology, University of Maryland–College Park,
George Washington University
Understanding cell-to-cell heterogeneity necessitates specialized technologies
capable of single-cell sensitivity. Detection of functional molecules like proteins
remains a challenge due to a lack of sensitive technologies. To alleviate this
challenge, we developed single-cell proteomics technologies using high-
resolution mass spectrometry. In this presentation, we demonstrate the
applicability of our platform to characterize hundreds of different proteins in
single embryonic cells and small populations of neurons.
4:05 Networking Refreshment Break
ADDRESSING PRE-ANALYTICAL AND ANALYTICAL
CHALLENGES IN SCA
4:30 Challenges in the Design and Analysis of Single Cell
RNA-Seq Experiments
Joshy George, PhD, Associate Director, Computational Sciences, Jackson
Laboratory for Genomic Medicine
Recent advances in technology enable us to profile the expression levels of
individual cells and provide us the capacity to identify novel cell-types present
in a tissue. The ability to detect a novel cell-type depends on a number of
parameters, including the number of cells sampled, the differences between the
cell-types and the methods to analyze the dataset. In this talk, I will present an
empirical approach to help solve this problem.
5:00 Using Neural Networks to Represent, Query and Retrieve Single-
Cell RNA-Seq Data
Ziv Bar-Joseph, PhD, FORE Systems Professor of Computational Biology and
Machine Learning, Computational Biology, Carnegie Mellon University
We developed methods based on neural networks (NN) to analyze scRNA-Seq
data. NNs improve upon prior methods in both, the ability to correctly group cells
in experiments not used in the training and the ability to correctly infer cell type
or state by querying a database of hundreds of thousands of single cell profiles.
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CHI's 10th Annual Next Generation Dx Summit, August 20-24, 2018, Washington, DC

CHI's 10th Annual Next Generation Dx Summit, August 20-24, 2018, Washington, DC

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CHI's 10th Annual Next Generation Dx Summit, August 20-24, 2018, Washington, DC