CHI's Next Generation Dx Summit | August 25-27, 2020 | Washington, DC

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TABLE OF
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P R E M I E R S P O N S O R
Organized by
800+
Diagnostics
Professionals
58%of Attendees from
IVD & Pharma
42%
C-Suite &
Directors
60+Industry Leading
Sponsors &
Exhibitors
n Enabling Point-of-Care Diagnostics
n Point-of-Care Technologies
POCT TECHNOLOGIES
AND STRATEGY
n Enabling Point-of-Care Diagnostics
n Advanced Diagnostics for
Infectious Disease
POCT AND
INFECTIOUS DISEASE
n Enabling Technologies for
Liquid Biopsy
n Early Detection of Disease
LIQUID BIOPSY/
EARLY DETECTION
n Drug-Diagnostics Co-Development
& Companion Dx
n Immuno-Oncology Biomarkers
and Diagnostics
COMPANION DX AND
IO BIOMARKERS
n Coverage and Reimbursement
n Commercialization
BUSINESS
n Your NGS Lab: Relevant Issues
n NGS Advances and Multimodality
Assays
NGS ADVANCES
2020 CONFERENCE
PROGRAMS
NextGenerationDx.com
12th Annual
Advancing Diagnostics Together
AUGUST 25-27
WASHINGTON, DC
GRAND HYATT WASHINGTON

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TABLE OF CONTENTS
VIEW Enabling Point-of-Care Diagnostics
VIEW Point-of-Care Technologies
POCT TECHNOLOGIES AND STRATEGY STREAM
VIEW Enabling Technologies for Liquid Biopsy
VIEW Early Detection of Disease
LIQUID BIOPSY/EARLY DETECTION STREAM
VIEW Drug-Diagnostics Co-Development
& Companion Dx
VIEW Immuno-Oncology Biomarkers and Diagnostics
COMPANION DX AND IO BIOMARKERS STREAM
2020 CONFERENCE PROGRAMS
VIEW Enabling Point-of-Care Diagnostics
VIEW Advanced Diagnostics for Infectious Disease
POCT AND INFECTIOUS DISEASE STREAM
VIEW Coverage & Reimbursement
VIEW Commercialization of Diagnostic Tests
BUSINESS STREAM
Table of Contents
VIEW Your NGS Lab: Relevant Issues
VIEW NGS Advances and Multimodality Assays
NGS ADVANCES STREAM
VIEW ABOUT THE SUMMIT
VIEW CONFERENCE AT-A-GLANCE
VIEW PLENARY KEYNOTE PRESENTERS
VIEW SHORT COURSES
VIEW TRAINING SEMINAR
VIEW POSTERS
VIEW HOTEL & TRAVEL
VIEW 2020 SPONSORS
VIEW MEDIA PARTNERS
VIEW SPONSOR & EXHIBIT INFORMATION
VIEW REGISTRATION INFORMATION
BACK TO COVER

TABLE OF CONTENTS
T
For more than a decade, 800 industry professionals
have considered the Next Generation Dx Summit in
Washington, DC a nexus for key decision and policy-
makers, academic and industry leaders to learn the
latest technologies, assays, sample prep and detection
methods, analysis and machine-learning approaches
that drive innovation. Regulatory and reimbursement
solutions will be featured that are critical to the
implementation of value-based care.
Non-invasive, rapid diagnostics tests are advancing to help manage outbreaks
and emerging pathogens. Immunotherapy biomarkers and companion
diagnostics are vital tools for the pharma and biotech industries, and the
implementation of these tests will ensure the safety and viabilities of these
essential therapies.
TABLE OF CONTENTS
Welcome
PRE-CONFERENCE
SHORT COURSES
August 24
Monday
DINNER SHORT
COURSES
August 26
Wednesday PM
August 25 - 26 | Tuesday - Wednesday AM | PART A CONFERENCES
STREAM
Enabling Point-of-Care Diagnostics Point-of-Care Technologies
WTM
August 26 - 27 | Wednesday PM - Thursday | PART B CONFERENCES
Conference At-A-Glance
#NGDx20
SHORT
COURSES
Enabling Technologies for Liquid Biopsy
LIQUID
BIOPSY/EARLY
DETECTION
Early Detection of Disease
Your NGS Lab: Relevant Issues (Training Seminar)
NGS
ADVANCES
Enabling Point-of-Care Diagnostics Advanced Diagnostics for Infectious Disease
Drug-Diagnostics Co-Development & Companion Dx
COMPANION
DX AND IO
BIOMARKERS
Immuno-Oncology Biomarkers and Diagnostics
POCT AND
INFECTIOUS
DISEASE
Coverage and ReimbursementBUSINESS Commercialization of Diagnostic Tests
POCT
TECHNOLOGIES
AND STRATEGY
NGS Advances and Multimodality Assays
SHARED
PROGRAMS

TABLE OF CONTENTS
11:30 am
Chairperson’s Remarks
11:35
Diagnostic Technologies that Will Shape
Precision Medicine in 2020 and Beyond
David Walt, PhD, Hansjörg Wyss Professor, Biologically Inspired Engineering, Harvard Medical
School; Professor, Department of Pathology, Brigham and Women’s Hospital; Core Faculty, Wyss
Institute for Bioinspired Engineering, Harvard University, HHMI Professor
Precision medicine is being driven by the ability to measure biomarkers at an unprecedented
scale. New technologies that enable the measurement of proteomic and genomic signatures,
engineered nanomaterials for diagnostics and imaging, smart watches, and new imaging
modalities provide personalized profiling that can be used to guide therapies. In order for these
technologies to have the greatest benefit, there will need to be profound changes in the entire
diagnostics ecosystem.
12:05 pm
PANEL DISCUSSION:
What Technologies Will Shape
Precision Medicine in 2020?
Moderator: Susan Hsiao, MD, PhD, Assistant Professor, Pathology and Cell Biology, Columbia
University Medical Center
Panelists: Jonathan Nowak, MD, PhD, Assistant Professor, Pathology, Harvard Medical School;
Associate Pathologist, Brigham and Women’s Hospital
David Walt, PhD, Hansjörg Wyss Professor, Biologically Inspired Engineering, Harvard Medical
School; Professor, Department of Pathology, Brigham and Women’s Hospital; Core Faculty, Wyss
Institute for Bioinspired Engineering, Harvard University, HHMI Professor
What is the clinical impact of some of the following technologies and what are the current
bottlenecks and challenges that need to be surmounted? Examples of each will be given:
• RNA sequencing
• Single-cell sequencing and analysis
• AI and machine learning
• Tumor mutational burden measurement
• Emerging uses of NGS
• Tumor microenvironment
• Multi-modality and transcriptomics
• Microbiome
12:35
Plenary Keynote Introduction
Charles Mathews, Principal, ClearView Healthcare Partners
12:45-1:15
Fireside Chat
Moderator: Charles Mathews, Principal, ClearView Healthcare Partners
Sara Brenner, MD, MPH, Associate Director for Medical Affairs; CMO, In Vitro Diagnostics, Office
of In Vitro Diagnostics & Radiological Health (OIR), Office of Product Evaluation & Quality (OPEQ),
Center for Devices & Radiological Health (CDRH), U.S. Food & Drug Administration
The value per minute
per day was just
off the charts.
VP Marketing, Click Diagnostics
“ “
WEDNESDAY, AUGUST 26
Plenary Keynote Session
Co-Organized by

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Sponsors
PREMIER SPONSORS
CORPORATE SPONSORS
CORPORATE SUPPORT SPONSORS

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VIEW EXHIBIT FLOORPLAN
DOWNLOAD EXHIBITOR PROSPECTUS
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
delates. Speak face-to-face with prospectus 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
• Mobile App 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!
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.
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.
ATTENDEES BY GEOGRAPHIC LOCATION
REST OF
WORLD: 2%
USA:
89%
EUROPE:
6%
ASIA:
3%
2019 ATTENDEE DEMOGRAPHICS
n IVD & Pharma................. 57%
n Academic Labs............... 12%
n Healthcare Provider...........9%
n Healthcare.........................8%
n Government.......................6%
n Services..............................4%
n Societies............................3%
n Other...................................1%
COMPANY
TYPE
n Executive & Director.......41%
n Manager..........................11%
n Professor........................10%
n Scientist/
Technologist...................18%
n Sales & Marketing..........17%
n Other..................................3%
DELEGATE
TITLE
For more information regarding sponsorship
and exhibit opportunities, please contact
COMPANIES A-K
Jon Stroup | Sr Business Development Manager
781-972-5483 | jstroup@cambridgeinnovationinstitute.com
COMPANIES L-Z
Ashley Harvey | Business Development Manager
781-247-6292 | aharvey@cambridgeinnovationinstitute.com

TABLE OF CONTENTS
Short Courses*
MONDAY, AUGUST 24
MORNING, 9:00 AM–12:00 PM
SC1: Technologies, Applications and
Commercialization of POC Dx
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH
This short course will provide an overview on the technological
aspects of POC system developments. It will introduce current
technologies such as microfluidics, sensors, paper- and
smartphone-based approaches and discuss their trends and
limitations. The course will discuss a variety of POC systems
in different stages of their development, from early stage to
established diagnostic systems in the clinical routine. Market
aspects of POC systems as well as practical examples of
commercialization for molecular diagnostic, immunological and
clinical tests will be presented.
SC2: Global Companion Diagnostic
Commercialization Bootcamp
Charles Mathews, Principal, ClearView Healthcare Partners
Successful development and launch of companion diagnostics
require careful consideration of an array of success factors. All
too often there are difficult transitions between development,
regulatory approval, and assay commercialization. In this
short course, you will hear about global companion diagnostic
commercialization from industry experts with both diagnostic and
pharma perspectives. Attendees will learn from the successes
and failures of various companion diagnostic launches and will
be able to take away best practices that can be aligned to their
own projects/programs. The course will conclude with a deep-
dive examination of a particularly interesting example, the launch
of one of the first next-generation sequencing-based companion
diagnostics, the Thermo Fisher’s Oncomine™ Dx Target test.
AFTERNOON, 2:00–5:00 PM
SC3: Liquid Biopsies Based on Extracellular
Vesicles: Prospects, Challenges, and
Opportunities
Joshua Smith, PhD, Research Staff Member, Translational Systems
Biology and Nanobiotechnology, IBM T.J. Watson Research Center
Hakho Lee, PhD, Associate Professor and Hostetter MGH Scholar,
Center for Systems Biology, Massachusetts General Hospital
Extracellular vesicles (EVs) exhibit a number of properties that
make them attractive as a rich source of biomarkers for disease
diagnosis, treatment monitoring, and therapeutics, including their
abundance in a wide breadth of bodily fluids, nucleic acid and
protein content, and protective lipid membrane that preserves this
cargo from degradation. This course reviews key discoveries in
EV research, describes current efforts to exploit their properties
to capture market value, and takes a look at exploratory and
emerging technologies aimed at accelerating their study and
use. Existing gaps in understanding, along with current efforts to
address these unknowns, will also be elucidated.
SC4: Accessing Point-of-Care Markets in the
US, Europe, and China
Lawrence Worden, Founder, Principal, IVD Logix
Lucy Hattingh, MBA, Principal, Lucy Hattingh Consulting
Nathaniel Whitney, President, Whitney Research
SC5: Regulatory, Reimbursement & Quality
Issues in Advanced Diagnostics
Melina Cimler, PhD, CEO & Founder, PandiaDx
Hilary Ann Baldwin, Regulatory Director, Regulatory, Caris Life
Sciences
Danielle Scelfo, Senior Director, Health Policy and Reimbursement,
Hologic, Inc.
DINNER, 7:00-9:30 PM
SC6: Microfluidics and Lab-on-a-Chip
Devices for POCT: Technologies and
Commercialization
Evan Cromwell, President & CEO, Protein Fluidics
This short course will provide an overview of microfluidic
techniques, including valved and valve-less devices, pumped
systems, and capillary flow approaches. Practical examples
will keep the discussion grounded in the realization of
commercializable devices. We will discuss engineering
approaches to enhance the advantages and minimize the
challenges. Throughout, the science will be linked to the
commercial case for these devices, including a full discussion
of a recent success story of a centrifugal microfluidic molecular
assay system.
SC7: Early Cancer Detection
Nicholas Dracopoli, PhD, CSO, DELFI Diagnostics
There is a growing need for new diagnostic tests to detect early
stages of cancer. This need is driven by the better treatment
response and prolonged survival of patients whose cancer is
detected in early stages. These cancers are small, localized,
and genetically more homogeneous than late-stage tumors
that are larger, more heterogeneous, and have spread to distant
organs. Early cancers are hard to detect because they do not
have necrotic cores and may not yet be recognized by the
immune system, so few of their cells are dying and releasing
their contents into circulation. This course will discuss several
different approaches to look for canonical cancer mutations, or
downstream consequences of these mutations, to identify pre-
symptomatic, non-metastatic cancers and to develop novel tests
with high sensitivity and specificity for the detection of early-
stage disease.
SC8: The COVID-19 Case Study: Accelerated
Development of Diagnostics for Novel
Infectious Disease Threats
Helen Roberts, Ph., President, Seegene Technologies
Lawrence J. Worden, Founder, Principal, IVD Logix
Fritz Eibel, Senior Vice President, Global Sales, Active Motif
*Separate registration required

TABLE OF CONTENTS8 | NextGenerationDX.com REGISTER EARLY & SAVE!
CONFERENCE STREAMS
POCT Technologies
and Strategy Stream
AUGUST 25-26
AGENDA Enabling Point-of-Care Diagnostics
AUGUST 26-27
AGENDA
Point-of-Care Technologies
2020 POCT TECHNOLOGIES AND STRATEGY CONFERENCES
POCT TECHNOLOGIES AND STRATEGY
POCT AND INFECTIOUS DISEASE
LIQUID BIOPSY/EARLY DETECTION
COMPANION DX AND IO BIOMARKERS
BUSINESS
NGS ADVANCES

TABLE OF CONTENTS
Recommended Short Courses*
SC1: Technologies, Applications and Commercialization
of POC Dx
SC4: Accessing Point-of-Care Markets in the US,
Europe, and China
*Separate registration required, click here for details
TUESDAY, AUGUST 25
7:30 am Registration and Morning Coffee
REDUCING ERRORS AT THE POINT-OF-CARE
8:30 Chairperson’s Opening Remarks
James Nichols, PhD, DABCC, FACB, Professor, Pathology,
Microbiology and Immunology; Medical Director, Clinical Chemistry;
Medical Director, POCT, Vanderbilt University School of Medicine
8:40 Real-World Issues Encountered with POCT
Valerie Ng, MD, PhD, Chair, Department of Laboratory Medicine &
Pathology; Laboratory Director, and Director, Transfusion Services,
Clinical Laboratories, Alameda Health System
Caregivers expect point-of-care testing (POCT) to be fast and
accurate. And, while manufacturers design their POCTs with these
goals in mind, real-world testing often defeats the purpose of the
best designed POCT system or device. This talk will present real-
world vignettes of POCT, highlighting the impact of non-laboratory
test personnel, patient care time pressures, and less than orderly
environments on POCT devices, their performance, and quality of
test results. Suggestions for improved POCT design based on these
known real-world pitfalls will be presented.
9:10 Challenges and Practical Solutions in Implementing
Point-of-Care Testing
Joseph Wiencek, PhD, Assistant Professor, Department of Pathology;
Medical Director, Point-of-Care Testing; Associate Medical Director,
Clinical Chemistry; Co-Director, Clinical Chemistry Fellowship,
University of Virginia School of Medicine
Point-of-care testing (POCT) is universal in modern healthcare.
New and innovative technologies permit diagnostic tests to leave
the confines of the centralized laboratory and migrate to the site
of patient care. Unfortunately, the excitement of this technology
is often lost due to an assortment of practical obstacles. Many of
these challenges will be discussed and practical solutions will be
offered.
9:40 Risk Management for Point-of-Care Testing
Point-of-care testing is laboratory testing conducted close to the site
of patient care. As tests migrate out of the laboratory, devices are
subject to environmental extremes and operator variation that can
impact patient results. Errors with point-of-care testing can come
from a number of sources, including the instrument, the operator,
the reagent, and the environment. Staff need to be cognizant of the
probability for error and take actions to prevent and detect errors
before they affect results and patient care. Risk management steps
through the testing process detecting potential sources for error,
then acts through training, maintenance, or the addition of control
processes to minimize the potential for errors. This presentation
will discuss the common sources of POCT error, describe how
manufacturers are engineering their products to prevent errors, and
will identify ways that institutions can design their quality control
programs to minimize error.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
10:55 Chairperson’s Remarks
11:00 Let’s Talk about Quality Control & Individualized
Quality Control Plans
Jelani Sanaa, MS, MLS (ASCP) CMSBBCM, SHCM, Clinical Laboratory
Scientist, Centers for Medicare and Medicaid Services (CMS);
Centers for Clinical Standards and Quality (CCSQ); Quality, Safety and
Oversight Group (QSOG); Division of Clinical Laboratory Improvement
and Quality (DCLIQ)
IQCP provides laboratories with flexibility in customizing quality
control (QC) policies and procedures for non-waived testing,
based on the test systems in use and the unique aspects of each
laboratory. IQCP is voluntary. Laboratories can achieve compliance
by following manufacturer’s guidelines and all CLIA QC regulations
as written. If those guidelines are less stringent than CLIA, or if
the manufacturer does not provide guidelines, the laboratory must
implement an IQCP.
11:30 Talk Title to be Announced
Corinne Fantz, PhD, Director, Scientific Affairs, Roche
12:00 pm Talk Title to be Announced
Chris Myatt, PhD, CEO, MBio Diagnostics, Inc.
12:15 Rapid POC Solutions for SARS CoV-2
and Associated Respiratory Pathogens
Claire Huguet, Head, Biomarker Services, Randox Biosciences
Randox is committed to developing infectious syndromic panels to
provide precise diagnostics. In collaboration with Bosch, Randox
has now released several IVD-quality tests on the POC Vivalytic
platform. The latest extended coronavirus 10-plex viral panel detects
the SARS-CoV-2 target, MERS, SARS, and 7 other respiratory viruses
resulting in similar clinical presentation.
12:30 Luncheon Presentation (Sponsorship Opportunity
Available) or Enjoy Lunch on Your Own
1:00 Refreshment Break in the Exhibit Hall with Poster
Viewing
PREPARING FOR THE NEXT WAVE OF POC
DIAGNOSTICS: OVERCOMING CHALLENGES WITH
CONSUMER TESTING
1:35 Encouraging Innovation: BARDA’s Division of Research,
Innovation and Ventures (DRIVe)
Šeila Selimović, PhD, Program Manager, Early Notification to Act,
Control, and Treat (ENACT), Division of Research, Innovation, and
Ventures (DRIVe), Biomedical Advanced Research and Development
Authority (BARDA), Office of Assistant Secretary for Preparedness and
Response (ASPR), U.S. Department of Health and Human Services
(HHS)
The Early Notification to Act, Control and Treat Program within
BARDA/DRIVe aims to protect Americans and save lives via
pre-symptomatic technology. ENACT seeks pathogen and insult
agnostic technologies to identify, characterize, and adapt signatures
(biological, biometric, behavioral, and physiological) that can inform
on health security threats or exposures prior to symptom onset to
facilitate treatment and prevent subsequent cascading effects where
possible. We are exploring discovery and validation of biomarkers
suitable for non-invasive or minimally invasive collection and other
health signatures and tools, empowering individuals to take initial
steps to determine health changes that assist clinician care by
determining appropriateness of antibiotic vs. antiviral treatment and
CBCs from remote settings, including the home.
CHI’S 14TH ANNUAL | AUGUST 25-26, 2020
Enabling Point-of-Care Diagnostics
IMPLEMENTATION AND BUSINESS STRATEGIES

TABLE OF CONTENTS
ENABLING POINT-OF-CARE DIAGNOSTICS, continued
2:05 Overcoming Regulatory Challenges for Home-Use Tests
Elliot Cowan, PhD, Principal, Partners in Diagnostics
Home-use tests can increase access to testing, safeguard privacy,
empower individuals to take control of their healthcare decisions,
and protect public health. However, these benefits come with
significant risks and challenges, including how to demonstrate
that the benefits outweigh the risks, how to address the need for
infectious disease reporting, and post-market surveillance. This talk
will describe how regulators deal with such issues to bring home-use
tests to market.
2:35 Innovative Approaches to At-Home Collection for STI
Testing
Charlotte Gaydos, MS, MPH, DrPH, Professor, Division of Infectious
Diseases, Johns Hopkins University
The iwantthekit (IWTK) program offers internet-requested kits for
home collection for screening of common STI. Other programs
exist. We will discuss innovation programs and acceptability for
home collection, and we will review published programs. Many
studies reported use of and willingness to use home collection when
available. There was willingness to pay an average of $10-30. User
satisfaction was high for home collection.
3:05 Sponsored Presentation (Opportunity Available)
Viewing
CONSUMER TESTING (CONT.)
Lawrence Worden, Founder & Principal, IVD Logix
4:30 Professional Concerns with At-Home Testing
Jeanne Mumford, MT(ASCP), Manager, Point-of-Care Testing, Johns
Hopkins University
Currently at-home testing is available in many formats including
glucose, urine pregnancy, drug screens, HIV, STI’s and Strep A
testing. There are manufacturers who provide the consumer with
access to physician care for positive tests and some may even
benefit surveillance studies by reporting to local health departments.
The ability to give access to testing for those patient populations
that may be underserved or underinsured also weigh heavily in the
debate of OTC self-testing. Though many arguments support the use
of consumer OTC self-testing, there are still some concerns from a
quality assurance perspective from the medical technologist who
currently oversee point of care testing in the health care setting. In
this session, we will discuss some of those concerns from the point
of care coordinator’s point of view.
5:00 PANEL DISCUSSION: Overcoming Challenges with
Consumer Testing
Moderator: Lawrence Worden, Founder & Principal, IVD Logix
Panelists: Elliot Cowan, PhD, Principal, Partners in Diagnostics
Hopkins University
(HHS)
6:00 Welcome Reception in the Exhibit Hall with Poster
Viewing
7:00 Close of Day
7:15 am Registration
7:30 Problem Solving Breakout Discussions with Continental
Breakfast
DEPLOYING POINT-OF-CARE TESTING TO
MANAGE DISEASE OUTBREAKS
Gerald 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
8:30 Geospatial “Hot Spots” Need Rapid Point-of-Care
Diagnostics to Stop Highly Infectious Threats and
Antimicrobial Resistance
Increasingly, we observe the adverse personal, societal, economic,
and cultural impact of outbreaks, antimicrobial resistance, and
disasters. Nations are not prepared! POC strategies can mitigate
risk, reduce harm, and improve crisis standards of care. Global
solutions integrate national POCT policy and guidelines, and
distribute financial burden and reasonable business models.
9:00 Rapid Development of Diagnostic Tests for New
Threats: 2019 Novel Coronavirus Pneumonia (COVID-19)
and Other Pathogens
Timothy Minogue, Diagnostic Systems Division, United States Army
Medical Research Institute of Infectious Diseases
To bridge the gap between rapid point-of-care diagnostics and
sequencing, we developed a highly multiplexed assay designed
to detect 164 different viruses, bacteria, and parasites using the
NanoString nCounter platform. Included in this assay were high-
consequence pathogens, such as Ebola virus, highly endemic
organisms including several Plasmodium species, and a large
number of less prevalent pathogens to ensure a broad coverage of
potential human pathogens.
9:30 Point-of-Care Molecular Diagnostics for Disease
Outbreak Settings: The Path to the Future
Rachel Spurbeck, PhD, Principal Research Scientist, Health Outcomes
and Biotechnology Solutions, Battelle Memorial Institute
Rapid, accurate, and affordable point-of-care (POC) diagnostics
are key to detecting and subsequently mitigating the impact of
disease outbreaks, particularly for emerging pathogens. Molecular
approaches to detection offer speed, sensitivity, and specificity, but
can introduce complexity and expense, making it difficult to achieve
a POC diagnostic suitable for use outside a clinical setting. This
talk will review the current state of the art for molecular diagnostics
and examine the path forward to deployable POC diagnostics
for outbreak settings, including some of the challenges being
undertaken today.
10:00 Presentation to be Announced
10:30 Coffee Break in the Exhibit Hall with
Poster Viewing
11:30 Plenary Keynote Session
Please click here for details
1:15 pm Luncheon Presentation (Sponsorship Opportunity
1:45 End of Enabling Point-of-Care Diagnostics
Recommended Dinner Short Course*
Development of Diagnostics for Novel Infectious
Disease Threats

TABLE OF CONTENTS
Viewing
INNOVATING THE NEXT GENERATION OF POC
Nardev Ramanathan, PhD, Global Lead Analyst, Digital Transformation,
Lux Research, Inc.
2:20 AI-Linked Precision Lesion Diagnostics
John McDevitt, PhD, Chair, Department Biomaterials, New York
University College of Dentistry
2:50 The Next Generation of Continuous Diagnostic Sensors:
A Case Study on the Breakthroughs for Sweat Biosensing
Jason Heikenfeld, PhD, Vice President, Operations, Office of
Innovation; Professor and Director, Novel Device Laboratory, University
of Cincinnati
Continuous biosensing promises to bring the lab into a wearable
format that measures anything from cardiac health to pre-
symptomatic viral detection. The reality of this promise is
that success continues to be limited to glucose monitoring
or conventional, decades-old optical or electrical non-specific
measures. We present the real challenges the field faces, along with
first-ever breakthroughs that have resulted in non-invasive wearables
that can provide continuous blood-correlated chemical data. Our
case study is sweat biosensing, but learnings apply to all other forms
of biofluid access (saliva, tears, urine, interstial fluid).
3:30 Developing Next-Generation Diagnostics to Meet
Clinical Needs
Ping Wang, PhD, DABCC, Chief, Clinical Chemistry; Director, Core
Laboratory Hospital, University of Pennsylvania
The field of point-of-care technologies has witnessed strong
growth, as evidenced by new clinical or consumer products or
research and development directions. Only when combined with
appropriate strategies for clinical needs assessment, validation and
implementation, these technologies may significantly impact care
delivery and associated outcomes and costs. In this presentation, I
will discuss clinical needs, validation and implementation strategies
for novel point-of-care technologies from two perspectives: as a
practicing clinical laboratory director and as a technology researcher
and developer.
3:50 Fluorescence-Based Detection Platform
for Immunoassays: Manufacturing Challenges
Violeta Tacheva, Lifecycle Manager, STRATEC Consumables GmbH
The social importance of the market approved point-of-care
products remained uncontroversial. Stratec Consumables GmbH
will present some manufacturing possibilities and the challenges
during developing of scalable high quality, reproducible and reliable
products. As example, we will present a fluorescence-based
detection platform for immunoassays.
4:20 Refreshment Break in the Exhibit Hall with
Poster Viewing
REDEFINING POC IN THE DIGITAL ERA
Sharief Taraman, MD, CMO, Cognoa; Division Chief, CHOC Children’s
Hospital
5:10 Fast, Accurate, and Actionable: How Digital Tools in
Femtech Unlock a $50 Billion Market
Danielle Bradnan, MS, Research Associate, Digital Health and
Wellness, Lux Research
Current diagnostic paradigms often leave women’s health as a
secondary or niche consideration, which has led to considerable
struggles for over half of the global population in terms of getting a
rapid, accurate, and actionable diagnosis. However, with the advent
of digital tools such as apps, wearables, and AI, healthcare startups
are rapidly developing solutions to close the gap between symptoms
and diagnosis. We will explore the current solution landscape in this
talk and highlight the opportunities that diagnostic tools offer.
5:40 Advancing Care with Digital Therapeutics
Sharief Taraman, MD, CMO, Cognoa; Division Chief, CHOC Children’s
Hospital
Early intervention of autism is proven to impact a child’s lifelong
outcomes, but today’s system misses the critical window when
treatment has its greatest impact. This session explains how a
clinically validated, AI-powered prescription diagnostic, designed
for use by pediatricians, can streamline and scale early diagnosis
and fast-track access to care. Audiences will understand how digital
therapeutics can enable equitable health outcomes for children with
behavioral health conditions.
6:10 Development of a Smartphone App for Non-Invasive
Detection of Anemia Using Only Patient-Sourced Photos
Wilbur Lam, MD, PhD, W. Paul Bowers Research Chair, Associate
Professor, Department of Pediatrics, Wallace H. Coulter Department
of Biomedical Engineering, Aflac Cancer and Blood Disorders Center
of Children’s Healthcare of Atlanta; Chief Innovation Officer, Pediatric
Technology Center, Emory University and Georgia Institute of Technology
We introduce a paradigm of non-invasive, on-demand diagnostics
for hematologic diseases using only a smartphone app and photos.
We initially targeted anemia, characterized by low blood hemoglobin
levels, which afflicts >2 billion people. Our app estimates
hemoglobin levels by analyzing color and metadata of fingernail
smartphone photos and screens for anemia (hemoglobin levels
<12.5 g/dL) with a 97% sensitivity (n = 100 subjects). Moreover, with
personalized calibration, this system achieves an accuracy of ±0.92
g/dL compared to gold standard hemoglobin levels (n = 16 subjects),
empowering chronic anemia patients to serially monitor their
hemoglobin levels instantaneously and non-invasively.
6:40 Close of Day
6:40 Dinner Short Course Registration*
7:00 - 9:30 Dinner Short Course*
SC6: Microfluidics and Lab-on-a-Chip Devices for POCT:
Technologies and Commercialization
THURSDAY, AUGUST 27
Breakfast
IMPROVING POC
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH
8:30 Novel Techniques for POC Disease Monitoring Utilizing
Programmable Molecular Velcro
Kaylyn Oshaben, PhD, Synthetic Biology Specialist, Altratech Limited
Altratech is interested in moving disease monitoring to the point-of-
care and beyond. Common barriers to implementing point-of-care
CHI’S 2ND ANNUAL | AUGUST 26-27, 2020
Point-of-Care Technologies
EXPLORING MICROFLUIDICS, SENSORS & DIGITAL TOOLS

TABLE OF CONTENTS
POINT-OF-CARE TECHNOLOGIES, continued
or home nucleic acid disease monitoring systems revolve around
sample prep, reagent storage and user expertise. To overcome some
of these barriers, we are developing new techniques that utilize
peptide nucleic acids (PNA) as both enrichment and capture agents
that simplify sample prep, reagents and detection technology.
9:00 Application of Intelligent Quality Management at Point-
of-Care
Sohrab Mansouri, PhD, Staff Scientist, Advance Development,
Instrumentation Laboratory
This presentation describes an integrated QC method based on
identifying error patterns for a given measurement system and
devising a method for rapid detection and targeted corrective action
with no user involvement.
9:45 Sponsored Presentation (Opportunity
Available)
FEATURED SESSION: NUCLEIC ACID DETECTION
Shawn Mulvaney, PhD, Section Head, Surface Nanoscience and
Sensor Technology Section, Chemistry, US Naval Research Laboratory
11:05 Global Considerations with Nucleic Acid at POC
Nardev Ramanathan, PhD, Global Lead Analyst, Digital Transformation,
Lux Research, Inc.
Nucleic acid amplification technologies (NAATs) are high-
performance tools for rapidly and accurately identifying pathological
changes, be it in the patient’s DNA or in the RNA/DNA of pathogens
in the case of infectious diseases. Traditionally, these diagnostic
tests take time, and require centralized labs with highly skilled and
trained staff, appropriate infrastructure, quality assurance protocols
and controlled environments to house complex equipment and
cold chain-dependent reagents. However, access to this becomes
challenging for decentralized settings with large and complex
geographies and/or low- and middle-income countries with
large burdens of infectious disease and challenged by extreme
environments, poor infrastructure, few trained staff and limited
financial resources. Point-of-care (POC) capabilities for nucleic acid
testing offer huge opportunities here to tackle this unmet need.
Many recent advances are bringing us closer to this reality, mostly
around microfluidics and miniaturization of biosensors. However,
there are still other considerations to be had, around population
and sociodemographic differences that will impact how these
technologies will be implemented and deployed. This talk will tackle
the global considerations for nucleic acid POC using case studies of
currently deployed medical technologies as examples.
11:35 Engineering Biology for Diagnostic Solutions
William Blake, PhD, CTO, Sherlock Bioscience
SHERLOCK is a method for single molecule detection of nucleic
acid targets and stands for Specific High Sensitivity Enzymatic
Reporter unLOCKing. It works by amplifying genetic sequences
and programming a CRISPR molecule to detect the presence of a
specific genetic signature in a sample, which can also be quantified.
When it finds those signatures, the CRISPR enzyme is activated and
releases a robust signal. This signal can be adapted to work on a
simple paper strip test, in laboratory equipment, or to provide an
electrochemical readout that can be read with a mobile phone.
12:05 pm Instrument-Free Paper-Based POC Pathogen
Diagnostics for the Clinic and the Home
Paul Yager, PhD, Professor, Bioengineering, University of Washington
Instruments ranging from the venerable GeneXpert to ones just
coming on the market allow fairly rapid NAAT pathogen detection,
but they are based on disposable cartridges and a permanent
(and relatively expensive) instrument. Our lab has been developing
instrument-free disposable NAAT devices that retain the advantages
of the instrumented systems, but free the user from the need for
purchasing a permanent instrument (and the up-front cost that
incurs).
Viewing
SUCCESSFUL CASE STUDIES
Richard Chasen Spero, PhD, CEO, Redbud Labs, Inc.
2:20 CASE STUDY: From AIDS to Ebola, Commercializing
Rapid Tests for Infectious Disease
Stephen Tang, PhD, President & CEO, OraSure Technologies, Inc.
OraSure CEO Stephen S. Tang, PhD will discuss OraSure’s
experiences developing and commercializing industry-leading
diagnostics to power public health. Dr. Tang will share OraSure’s
experience commercializing its trailblazing rapid point of care tests
for HIV and HCV and its FDA-cleared rapid antigen test for Ebola.
2:40 CASE STUDY: eRAPID Technology – A Universal
Electrochemical Sensor Platform
Pawan Jolly, PhD, Senior Scientist, Wyss Institute, Harvard University
A case of developing a sensitive and robust biosensor for early
detection of allergies as part of Project ABBIE will be presented. I will
also share my journey of how to transition from a university research
project to a diagnostic start up.
3:00 CASE STUDY: Federal Resources for Early Stage
Diagnostic Start Up
Tiffani Lash, PhD, Program Director, National Institutes of Health
I will discuss the federal resources for early stage companies that
fall into the research portfolios of biosensors, platform technologies,
and mHealth programs at NIH. NIBIB Point-of-Care Technologies
Research Network will be explained, consisting of three centers
charged with developing point-of-care diagnostic technologies
through collaborative efforts that merge scientific and technological
capabilities with clinical need.
3:20 PANEL DISCUSSION: Commercializing Point-of-Care
Tests
Moderator: Richard Chasen Spero, PhD, CEO, Redbud Labs, Inc.
Panelists: Stephen Tang, PhD, President & CEO, OraSure Technologies,
Inc.
Pawan Jolly, PhD, Senior Scientist, Wyss Institute, Harvard University
Tiffani Lash, PhD, Program Director, National Institutes of Health
• Platforms that are used for testing
• Why are these formats important?
• What’s the driver for growth?
• How did they build their companies?
• Where the industry is and where it is headed
4:20 End of Summit

TABLE OF CONTENTS
POCT and Infectious
Disease Stream
AUGUST 25-26
AGENDA Enabling Point-of-Care Diagnostics
AUGUST 26-27
AGENDA
Advanced Diagnostics for Infectious Disease
2020 POCT AND INFECTIOUS DISEASE CONFERENCES
CONFERENCE STREAMS
BUSINESS
NGS ADVANCES

TABLE OF CONTENTS
of POC Dx
SC4: Accessing Point-of-Care Markets in the US,
Europe, and China
TUESDAY, AUGUST 25
REDUCING ERRORS AT THE POINT-OF-CARE
8:40 Real-World Issues Encountered with POCT
Valerie Ng, MD, PhD, Chair, Department of Laboratory Medicine &
Pathology, Laboratory Director, and Director, Transfusion Services,
Clinical Laboratories, Alameda Health System
Caregivers expect Point-of-Care Testing (POCT) to be fast and
accurate. And, while manufacturers design their POCTs with these
goals in mind, real-world testing often defeats the purpose of the
best designed POCT system or device. This talk will present real-
world vignettes of POCT, highlighting the impact of non-laboratory
test personnel, patient care time pressures, and less than orderly
environments on POCT devices, their performance, and quality of
test results. Suggestions for improved POCT design based on these
known real-world pitfalls will be presented.
9:10 Challenges and Practical Solutions in Implementing
Point-of-Care Testing
Joseph Wiencek, PhD, Assistant Professor, Department of Pathology;
Medical Director, Point-of-Care Testing; Associate Medical Director,
Clinical Chemistry; Co-Director, Clinical Chemistry Fellowship,
University of Virginia School of Medicine
Point-of-care testing (POCT) is universal in modern healthcare.
New and innovative technologies permit diagnostic tests to leave
the confines of the centralized laboratory and migrate to the site
of patient care. Unfortunately, the excitement of this technology
is often lost due to an assortment of practical obstacles. Many of
these challenges will be discussed and practical solutions will be
offered.
9:40 Risk Management for Point-of-Care Testing
Point-of-care testing is laboratory testing conducted close to the site
of patient care. As tests migrate out of the laboratory, devices are
subject to environmental extremes and operator variation that can
impact patient results. Errors with point-of-care testing can come
from a number of sources, including the instrument, the operator,
the reagent, and the environment. Staff need to be cognizant of the
probability for error and take actions to prevent and detect errors
before they affect results and patient care. Risk management steps
through the testing process detecting potential sources for error,
then acts through training, maintenance, or the addition of control
processes to minimize the potential for errors. This presentation
will discuss the common sources of POCT error, describe how
manufacturers are engineering their products to prevent errors, and
will identify ways that institutions can design their quality control
programs to minimize error.
11:00 Let’s Talk about Quality Control & Individualized
Quality Control Plans
Jelani Sanaa, MS, MLS (ASCP) CMSBBCM, SHCM, Clinical Laboratory
Scientist, Centers for Medicare and Medicaid Services (CMS);
Centers for Clinical Standards and Quality (CCSQ); Quality, Safety and
Oversight Group (QSOG); Division of Clinical Laboratory Improvement
and Quality (DCLIQ)
IQCP provides laboratories with flexibility in customizing Quality
Control (QC) policies and procedures for non-waived testing,
based on the test systems in use and the unique aspects of each
laboratory. IQCP is voluntary. Laboratories can achieve compliance
by following manufacturer’s guidelines and all CLIA QC regulations
as written. If those guidelines are less stringent than CLIA, or if
the manufacturer does not provide guidelines, the laboratory must
implement an IQCP.
11:30 Talk Title to be Announced
Corinne Fantz, PhD, Director, Scientific Affairs, Roche
12:00 pm Talk Title to be Announced
Chris Myatt, PhD, CEO, MBio Diagnostics, Inc.
12:15 Rapid POC Solutions for SARS CoV-2
and Associated Respiratory Pathogens
Claire Huguet, Head, Biomarker Services, Randox Biosciences
Randox is committed to developing infectious syndromic panels to
provide precise diagnostics. In collaboration with Bosch, Randox
has now released several IVD-quality tests on the POC Vivalytic
platform. The latest extended coronavirus 10-plex viral panel detects
the SARS-CoV-2 target, MERS, SARS, and 7 other respiratory viruses
resulting in similar clinical presentation.
Viewing
CONSUMER TESTING
1:35 Encouraging Innovation: BARDA’s Division of Research,
Innovation and Ventures (DRIVe)
(HHS)
The Early Notification to Act, Control and Treat Program within
BARDA/DRIVe aims to protect Americans and save lives via
pre-symptomatic technology. ENACT seeks pathogen and insult
agnostic technologies to identify, characterize, and adapt signatures
(biological, biometric, behavioral, and physiological) that can inform
on health security threats or exposures prior to symptom onset to
facilitate treatment and prevent subsequent cascading effects where
possible. We are exploring discovery and validation of biomarkers
suitable for non-invasive or minimally invasive collection and other
health signatures and tools, empowering individuals to take initial
steps to determine health changes that assist clinician care by
determining appropriateness of antibiotic vs. antiviral treatment and
CBCs from remote settings, including the home.
Enabling Point-of-Care Diagnostics
IMPLEMENTATION AND BUSINESS STRATEGIES

TABLE OF CONTENTS
ENABLING POINT-OF-CARE DIAGNOSTICS, continued
2:05 Overcoming Regulatory Challenges for Home-Use Tests
Elliot Cowan, PhD, Principal, Partners in Diagnostics
Home-use tests can increase access to testing, safeguard privacy,
empower individuals to take control of their healthcare decisions, and
protect public health. However, these benefits come with significant
risks and challenges, including how to demonstrate that the benefits
outweigh the risks, how to address the need for infectious disease
reporting, and post-market surveillance. This talk will describe how
regulators deal with such issues to bring home-use tests to market.
2:35 Innovative Approaches to At-Home Collection for STI
Testing
The iwantthekit (IWTK) program offers internet-requested kits for
home collection for screening of common STI. Other programs
exist. We will discuss innovation programs and acceptability for
home collection, and we will review published programs. Many
studies reported use of and willingness to use home collection when
available. There was willingness to pay an average of $10-30. User
satisfaction was high for home collection.
Viewing
DIAGNOSTICS: -OVERCOMING CHALLENGES
WITH CONSUMER TESTING (CONT.)
Lawrence Worden, Founder & Principal, IVD Logix
4:30 Professional Concerns with At-Home Testing
Hopkins University
Currently at-home testing is available in many formats including
glucose, urine pregnancy, drug screens, HIV, STI’s and Strep A
testing. There are manufacturers who provide the consumer with
access to physician care for positive tests and some may even
benefit surveillance studies by reporting to local health departments.
The ability to give access to testing for those patient populations
that may be underserved or underinsured also weigh heavily in the
debate of OTC self-testing. Though many arguments support the use
of consumer OTC self-testing, there are still some concerns from a
quality assurance perspective from the medical technologist who
currently oversee point of care testing in the health care setting. In
this session, we will discuss some of those concerns from the point
of care coordinator’s point of view.
5:00 PANEL DISCUSSION: Overcoming Challenges with
Consumer Testing
Moderator: Lawrence Worden, Founder & Principal, IVD Logix
Panelists: Elliot Cowan, PhD, Principal, Partners in Diagnostics
Hopkins University
Šeila Selimović, PhD, Program Manager, Early Notification to Act, Control,
and Treat (ENACT), Division of Research, Innovation, and Ventures
(DRIVe), Biomedical Advanced Research and Development Authority
(BARDA), Office of Assistant Secretary for Preparedness and Response
(ASPR), U.S. Department of Health and Human Services (HHS)
Viewing
7:00 Close of Day
Breakfast
DEPLOYING POINT-OF-CARE TESTING TO
MANAGE DISEASE OUTBREAKS
8:30 Geospatial “Hot Spots” Need Rapid Point-Of-
Care Diagnostics to Stop Highly Infectious Threats and
Increasingly, we observe the adverse personal, societal, economic,
and cultural impact of outbreaks, antimicrobial resistance, and
disasters. Nations are not prepared! POC strategies can mitigate
risk, reduce harm, and improve crisis standards of care. Global
solutions integrate national POCT policy and guidelines, and
distribute financial burden and reasonable business models.
9:00 Rapid Development of Diagnostic Tests for New
Threats: 2019 Novel Coronavirus Pneumonia (COVID-19)
and Other Pathogens
Timothy Minogue, Diagnostic Systems Division, United States Army
Medical Research Institute of Infectious Diseases
To bridge the gap between rapid point-of-care diagnostics and
sequencing, we developed a highly multiplexed assay designed
to detect 164 different viruses, bacteria, and parasites using the
NanoString nCounter platform. Included in this assay were high-
consequence pathogens, such as Ebola virus, highly endemic
organisms including several Plasmodium species, and a large
number of less prevalent pathogens to ensure a broad coverage of
potential human pathogens.
9:30 Point-of-Care Molecular Diagnostics for Disease
Outbreak Settings: The Path to the Future
Rachel Spurbeck, PhD, Principal Research Scientist, Health Outcomes
and Biotechnology Solutions, Battelle Memorial Institute
Rapid, accurate, and affordable point-of-care (POC) diagnostics
are key to detecting and subsequently mitigating the impact of
disease outbreaks, particularly for emerging pathogens. Molecular
approaches to detection offer speed, sensitivity, and specificity, but
can introduce complexity and expense, making it difficult to achieve
a POC diagnostic suitable for use outside a clinical setting. This
talk will review the current state of the art for molecular diagnostics
and examine the path forward to deployable POC diagnostics
for outbreak settings, including some of the challenges being
undertaken today.
Available)
1:45 End of Enabling Point-of-Care Diagnostics
Disease Threats

TABLE OF CONTENTS
Viewing
DEVELOPING AND SHOWING CLINICAL IMPACT
OF RAPID DIAGNOSTICS
Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and
Virology, Children’s Hospital Los Angeles; Associate Professor,
Pathology and Laboratory Medicine, Keck School of Medicine,
University of Southern California
2:20 Clinical Impact of Rapid Molecular Blood Culture Test
at a Tertiary Cancer Care Center
Esther Babady, PhD, Medical Director, Clinical Microbiology Service,
Memorial Sloan Kettering Cancer Center
Sepsis remains a significant cause of morbidity and mortality in
hospitalized patients. Cancer patients and other immunocompromised
hosts are particularly at increased risk of sepsis. Novel molecular
methods for rapid diagnosis directly from blood samples are now
available for identification of pathogens and select resistance markers.
This presentation will review the clinical impact of rapid molecular tests
on patient outcomes at a tertiary cancer care center.
2:50 What’s New in the Molecular Detection of Bloodstream
Infections?
Kimberly Hanson, MD, MHS, Director, Transplant Infectious
Diseases and Immunocompromised Host Service; Director, Medical
Microbiology Fellowship Program, Section Head, Clinical Microbiology,
University of Utah, ARUP Laboratories
Delayed diagnosis of bloodstream infections (BSI) is associated
with poor clinical outcomes. This session will review the current
landscape of BSI molecular diagnostic testing, including rapid
pathogen identification, antimicrobial drug resistance detection, and
the potential utility of host response signatures.
3:20 DOD’s Pursuit of Pre-Symptomatic Non-Invasive
Diagnostics
Edward Argenta, Science & Technology Manager, Biological &
Chemical Technologies, Defense Threat Reduction Agency
The Department of Defense, Chemical and Biological Technologies
Department is managing a disruptive portfolio developing algorithms
utilizing artificial intelligence approaches to deliver warning of an
acute exposure to a pathogen or toxic chemical prior to overt signs
and symptoms using non-invasive biomarkers. The portfolio has
shown successes in both animal and human exposure studies,
and will continue to pursue advancing the research to provide early
identification of exposure.
4:20 Refreshment Break in the Exhibit Hall with
Poster Viewing
MULTIPLEX PANELS
Esther Babady, PhD, Medical Director, Clinical Microbiology Service,
Memorial Sloan Kettering Cancer Center
5:10 Head-to-Head Comparison: Nanopore Sequencing
and Microarray Resequencing for Multiplex Pathogen
Identification
Robert Duncan, PhD, Principal Investigator, Office of Blood Research
and Review, Center for Biologics Evaluation and Research (CBER), FDA
GeneChip Resequencing microarrays have been advanced for
infectious disease agent detection and identification from Ebola to
Zika. Next-generation sequencing with the highly mobile and cost-
effective nanopore sequencing device is challenging the supremacy
of the microarray in rapid point-of-need pathogen detection. This
talk will present results of side-by-side application of these two
platforms for detection in pathogen-spiked blood samples and
compare their performance.
5:30 Syndromic Testing for Meningitis/Encephalitis: Saga of
the Love-Hate Relationship
As part of the Multiplex Panel session, this talk will focus on multiplex
testing for the laboratory diagnosis of meningitis and encephalitis
as compared to standard-of-care testing. The potential benefits
and limitations of panel testing for meningitis and encephalitis
compared to standard-of-care testing will be discussed. The potential
approaches to maximize testing yield will also be discussed.
5:50 The Biofire Pneumonia Panel: Does It Relate to
Microbiological and Clinical Variables?
Kenneth Rand, MD, Medical Director, Clinical Microbiology Laboratory;
Professor, Pathology and Medicine, University of Florida
The BioFire FilmArray Pneumonia Panel (PP) detects 15 common
bacterial pathogens semi-quantitatively (copy # from 104 to 107),
3 atypical pneumonia bacteria, 8 viruses, and 7 antimicrobial
resistance markers by multiplex PCR in about 1 hour in the
laboratory. Results of our 396-patient study suggest PP detects
more bacterial isolates than conventional microbiology, and the
copy number correlates with outcome variables, such as ICU length
of stay, temperature, and white cells in the BAL. Results reported
in a 3–4 h timeframe after a BAL could potentially improve both
antibiotic choice and de-escalation in critically ill intubated patients.
6:10 PANEL DISCUSSION: Advancing Multiplex Panels for
Clinical Diagnostics
Moderator: Esther Babady, PhD, Medical Director, Clinical Microbiology
Service, Memorial Sloan Kettering Cancer Center
Panelists: Robert Duncan, PhD, Principal Investigator, Office of Blood
Research and Review, Center for Biologics Evaluation and Research
(CBER), FDA
Kenneth Rand, MD, Medical Director, Clinical Microbiology Laboratory;
Professor, Pathology and Medicine, University of Florida
Tim Blauwkamp, PhD, CSO, Karius
• Comparison of multiplex platforms
• Reimbursement considerations
• Proving clinical utility of multiplex diagnostic tests
6:40 Close of Day
Disease Threats
Advanced Diagnostics for Infectious Disease
IMPROVING CLINICAL OUTCOMES THROUGH NOVEL TECHNOLOGY AND MOLECULAR TESTING

TABLE OF CONTENTS
THURSDAY, AUGUST 27
Breakfast
CONSIDERATIONS FOR AMR DIAGNOSTICS
Chairperson to be Announced, MeMed
8:30 I Don’t Watch Reality TV, I Live It – Reimbursement
Challenges under PAMA
Ester Stein, MBA, Director, Corporate Reimbursement, Government
Affairs, Abbott
This talk will focus on the reimbursement challenges under PAMA
for the more commonly performed diagnostic tests. The talk will
focus primarily on coding and payment issues, and will provide
policy updates.
8:45 Don’t Take That Antibiotic! You Might Get...Fat? The
Science of the Microbiome
Norman Moore, PhD, Director, Scientific Affairs, Abbott
Even though the global threat of antibiotic-resistant microorganisms
is significant, many patients demand antibiotics and doctors are
far too willing to provide them. This talk shows that the relationship
between us and our bacteria is more important than previously
thought. Disrupting that balance can cause a host of medical issues.
Sponsored by9:30 Serum Epitope Repertoire Analysis (SERA):
A Novel Serology Platform Enabling Multiplex
Diagnostics and Sero-Surveillance
Kathy Kamath, PhD, Director, Discovery, Research & Development,
Serimmune Inc.
SERA incorporates bacterial display peptide libraries, NGS, and
custom bioinformatics to profile antibody repertoires and map them
to infectious and other diseases. The platform enables parallel
testing of an unlimited number of biomarkers in a single, universal
assay, and quantitative longitudinal monitoring of that response as it
evolves over time.
Co-Organized withDIAGNOSTIC STEWARDSHIP
Joseph Campos, PhD, D(ABMM), F(AAM), Director,
Microbiology Laboratory, Infectious Disease
Molecular Diagnostics Laboratory, Laboratory Informatics, Children’s
National Medical Center; Strategic Alliances Liaison and Former
Secretary, ASM
11:05 Diagnostic Stewardship: Because You Can’t Do
Everything for Everyone All the Time
Christopher Doern, PhD, D(ABMM), Associate Director, Microbiology,
Virginia Commonwealth University Medical Center, Medical College of
Virginia Campus; Co-Chair, ASM’s Clinical Micro Open
11:25 The Role of Diagnostic Stewardship in Improving
Patient Care and Reducing Overall Healthcare Costs
Matthew Binnicker, PhD, Consultant, Division of Clinical Microbiology,
Department of Laboratory Medicine and Pathology; Vice Chair of
Supply Chain Management, Department of Laboratory Medicine and
Pathology; Vice Chair of Practice, Department of Laboratory Medicine/
Pathology, Mayo Clinic; Chair, ASM’s Professional Development
Subcommittee
Healthcare is transitioning from a fee-for-service model to one
focused on value-based care. As a key component of patient
care and the value-based equation, clinical laboratories will need
to be an active participant in the development of diagnostic
stewardship programs, so that healthcare providers are guided
towards the “right test, for the right patient, at the right time.” This
presentation will provide an overview of establishing an effective
diagnostic stewardship program, and provide examples of how
healthcare providers can be guided towards appropriate testing
and result interpretation. Specific case scenarios will be reviewed
to demonstrate how diagnostic stewardship can lead to increased
efficiency, reduced cost, and improved patient care.
11:55 A Laboratory Medicine Best Practices Systematic
Review and Meta-Analysis for the Laboratory Diagnosis of C.
Difficile
Colleen Kraft, MD, Associate Chief Medical Officer, Associate
Professor, Pathology/Laboratory Medicine, Medicine/Division of
Infectious Diseases, Emory University Hospital; Chair, ASM’s Evidence-
Based Laboratory Medicine Practice Guidelines
12:05 pm PANEL DISCUSSION: Extended Q&A with Session
Speakers
Moderator: Joseph Campos, PhD, D(ABMM), F(AAM), Director,
Microbiology Laboratory, Infectious Disease Molecular Diagnostics
Laboratory, Laboratory Informatics, Children’s National Medical
Center; Strategic Alliances Liaison and Former Secretary, ASM
Panelists: Speakers of the Session
1:05 Luncheon Presentation (Sponsorship
Opportunity Available) or Enjoy Lunch on Your Own
Viewing
CLINICAL METAGENOMIC SEQUENCING
Norman Moore, PhD, Director, Scientific Affairs, Abbott
2:20 Clinical Metagenomic Sequencing and Human Host
Response: Changing the Diagnostic Paradigm?
Charles Chiu, MD, PhD, 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) is a
transformative technology for infectious disease diagnosis as
it enables detection of nearly all pathogens – viruses, bacteria,
fungi, and parasites – in a single assay. Here we will discuss the
integration of multiple approaches to enhance the clinical utility of
body fluid mNGS, including nanopore sequencing, CRISPR-Cas12-
based pathogen detection, complementary host response analyses,
and simultaneous diagnosis of cancer.
2:50 Mycobacterial Infections in Immunocompromised
Patients, the Perfect Fit for Metagenomic Solutions
Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and
Medical Director, Medical College of Wisconsin
DETECTION OF RESISTANCE
3:20 Applying Next-Generation Sequencing for Detection of
Patricia Simner, PhD, D(ABMM), Associate Professor, Pathology;
Director, Bacteriology, Division of Medical Microbiology, The Johns
Hopkins University School of Medicine
3:50 FLASH: A Next-Generation CRISPR Diagnostic
for Multiplexed Detection of Antimicrobial Resistance
Sequences
Emily Crawford, PhD, Scientist II, Infectious Disease Initiative, Chan
Zuckerberg Biohub
4:20 End of Summit
ADVANCED DIAGNOSTICS FOR INFECTIOUS DISEASE, continued

TABLE OF CONTENTS
CONFERENCE STREAMS
Liquid Biopsy/
Early Detection Stream
AUGUST 25-26
AGENDA Enabling Technologies for Liquid Biopsy
AUGUST 26-27
AGENDA
2020 LIQUID BIOPSY/EARLY DETECTION CONFERENCES
BUSINESS
NGS ADVANCES

TABLE OF CONTENTS
Enabling Technologies for Liquid Biopsy
ADVANCING TECHNOLOGIES FOR CLINICAL UTILITIES
of POC Dx
SC3: Liquid Biopsies Based on Extracellular Vesicles:
Prospects, Challenges, and Opportunities
TUESDAY, AUGUST 25
EXOSOMES AND CIRCULATING TUMOR CELLS IN
CANCER LIQUID BIOPSY
8:40 The Wide World of Liquid Biopsy Biomarker Platforms
for Cancer Screening
Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute;
Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention;
Professor, Clinical Cancer Prevention-Research, Translational
Molecular Pathology, University of Texas MD Anderson Cancer Center
There is currently intense interest in developing liquid biopsy
applications for cancer screening with a multitude of platforms
being implemented to this effect. The contribution and merits of
biomarkers types for lung cancer screening will be presented.
9:10 Clinical Platform for Molecular Analyses of
Extracellular Vesicles
This presentation will discuss our key advances towards clinical
analyses of extracellular vesicles (EVs): i) development of a
high-throughput assay strategy, HiMEX (high-throughput magneto-
electrochemical exosome), and ii) assessment of EVs as potent
biomarkers for cancer management.
9:40 Chasing the Exosome Dream: Developing an Exosome-
Based Platform for the Screening and Monitoring of Lung
Cancer
Lydia Sohn, PhD, Chancellor’s Professor, Mechanical Engineering;
Faculty Assistant to the Vice Chancellor for Research, UC Berkeley
Although the standard of care for non-small cell lung cancer includes
surgery and many options for therapeutics, the response is highly
variable and patient specific. Detecting early-stage recurrence would
allow clinicians to adapt or change therapy within a curative window,
greatly improving outcomes and mortality rates. We are developing
a sensitive, simple-to-use, platform based on exogenous labeling
that could detect tumor-derived extracellular vesicles in blood and
saliva for patient monitoring.
11:00 Making Ultrasensitive Digital Droplet Assays Mobile
David Issadore, PhD, Assistant Professor, Bioengineering & Electrical
& Systems Engineering, University of Pennsylvania
We have developed a mobile phone-based imaging technique that
is >100× faster than conventional microfluidic droplet detection,
does not require expensive optics, is invariant to flow rate, and
can simultaneously measure multiple fluorescent dyes in droplets.
By using this time domain modulation with cloud computing,
we overcome the low frame rate of digital imaging, and achieve
throughputs as high as 1 million droplets per second. We integrate
on-chip delay lines and a microbead processing unit, resulting
in a robust device, suitable for low-cost implementation, with
ultrasensitive measurement capabilities. Additionally, I will present
unpublished data showing how this approach can be used for high-
throughput single extracellular vesicle analysis.
11:30 High-Throughput Label-Free Isolation of
Heterogeneous Circulating Tumor Cells and CTC Clusters
from Non-Small-Cell Lung Cancer Patients
Sunitha Nagrath, PhD, Associate Professor, Chemical Engineering,
University of Michigan
We applied an inertial microfluidic Labyrinth device for high-
throughput, biomarker-independent, size-based isolation of CTCs/
CTC clusters from patients with metastatic non-small-cell lung
cancer (NSCLC). The Labyrinth device recovered heterogeneous
CTCs in 100% and CTC clusters in 96% of patients with metastatic
NSCLC. The majority of recovered CTCs/clusters were EpCAM,
suggesting that these would have been missed using traditional
antibody-based capture methods.
12:00 pm Presentation to be Announced
Available)
12:30 LUNCHEON PRESENTATION:
Driving Clinical Confidence in Assay Development: The
Importance of Blood Sample Preservation
Speaker to be Announced
Viewing
ADVANCES IN DETECTING CELL-FREE DNA
G. Mike Makrigiorgos, PhD, Professor, Radiation Oncology, Dana-
Farber Cancer Institute and Harvard Medical School
1:35 FNIH Biomarkers Consortium Development of Quality
Control Materials for ctDNA Assays
Dana Connors, MSc, PMP, Senior Scientific Project Manager, Cancer,
Foundation for the National Institutes of Health
ctDNA shows great promise for cancer patient management but
there is a need for standardization in its use. A public private
partnership was initiated through the Biomarkers Consortium at the
FNIH to address this unmet need. This presentation will describe
how a pre-competitive alliance came together to better understand
the need and acceptable performance characteristics of quality
control materials, and provide an update on the intended use and
outcomes of the FNIH ctDNA Quality Control Materials project.
2:05 New Technologies for Low-Cost and Efficient Targeted
Re-Sequencing for Liquid Biopsy Applications
As the potential of liquid biopsies for prognostic, predictive or
early cancer detection applications grows, so does the demand
for technical advances to accompany the burgeoning range of
applications. We present new developments that enable targeted
re-sequencing for liquid biopsy applications at a fraction of the
current cost, while retaining or increasing sensitivity and specificity.
Examples for detecting low-level mutations in circulating DNA will be
presented.
2:35 Exploiting ctDNA Biology and Personalized Sequencing
for Sensitive Detection of Low Burden Disease
Christopher Smith, PhD, Research Associate, CRUK Cambridge
Institute, University of Cambridge (Nitzan Rosenfeld’s Laboratory)
Cell-free tumor derived DNA (ctDNA) analysis offers the potential
for minimally invasive detection of early stage disease as well as
minimal residual disease after treatment. However, the utility of
ctDNA is currently limited when the tumor burden is low. Here, I
will describe novel approaches that leverage knowledge of ctDNA
biology and personalized sequencing for sensitive detection even in
these challenging settings.

TABLE OF CONTENTS
ENABLING TECHNOLOGIES FOR LIQUID BIOPSY, continued
3:05 Nu.Q™ Capture – Isolation and Profiling
of Tumour-Derived Circulating Cell-Free
Nucleosomes
Mark Eccleston, Business Development Director, Volition
This talk focuses on the development of an efficient approach to
immunocapture of cell-free circulating nucleosomes, including the
enrichment of tumour-derived, circulating cell-free nucleosomes and
associated DNA from background nucleosomes of haematopoietic
origin. Clinical applications for mass spectrometry, immunoassay
and sequencing-based analysis of cell-free, circulating tumour
nucleosome will also be discussed.
Viewing
ADVANCES IN DETECTING CELL-FREE DNA
(CONT.)
G. Mike Makrigiorgos, PhD, Professor of Radiation Oncology, Dana
4:30 Targeted Digital Sequencing of Circulating Tumor DNA
for Minimal Residual Disease Detection and Treatment
Monitoring
Bradon McDonald, PhD, Computational Scientist II, Center for
Noninvasive Diagnostics, Translational Genomics Research Institute,
Phoenix ArizonaTARDIS (Muhammed Murtaza’s Laboratory)
Longitudinal analysis of circulating tumor DNA has shown promise
for monitoring treatment response. However, most current methods
lack adequate sensitivity for residual disease detection during or
after completion of treatment in patients with nonmetastatic cancer.
To address this gap, we have developed targeted digital sequencing
(TARDIS) for multiplexed analysis of patient-specific cancer
mutations. In this talk, I will share results of TARDIS benchmarking
and analysis of plasma samples from early-stage breast cancer
patients treated with neoadjuvant therapy.
5:00 PANEL DISCUSSION: Circulating Tumor DNA – Current
State and Future Development for Liquid Biopsy
Moderator: Sam Hanash, MD, PhD, Director, Red & Charline
McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair,
Cancer Prevention; Professor, Clinical Cancer Prevention-Research,
Translational Molecular Pathology, University of Texas MD Anderson
Cancer Center
Panelists: Dana Connors, MSc, PMP, Senior Scientific Project Manager,
Cancer, Foundation for the National Institutes of Health
Christopher Smith, PhD, Research Associate, CRUK Cambridge
Institute, University of Cambridge (Nitzan Rosenfeld’s Laboratory)
Bradon McDonald, PhD, Computational Scientist II, Center for
Noninvasive Diagnostics, Translational Genomics Research Institute,
Phoenix Arizona TARDIS (Muhammed Murtaza’s Laboratory)
Viewing
7:00 Close of Day
Breakfast
EMERGING TECHNOLOGIES FOR EARLY
DETECTION AND RECURRENCE
Lynn Sorbara, PhD, Program Director, Cancer Biomarkers Research
Group, National Cancer Institute (NCI), NIH
8:30 Detection of Exosomal Protein and MicroRNA
Combined Biomarkers via Exo-PROS Assay for Cancer Early
Detection
Yun (Sunny) Wu, PhD, Associate Professor, Biomedical Engineering,
University at Buffalo, The State University of New York
Exosomal proteins and microRNAs are promising biomarkers
for cancer liquid biopsy. We have developed an exosome protein
microRNA one stop (Exo-PROS) liquid biopsy assay, which enables
one-stop capture of tumor-derived exosomes (TEX) and sensitive
quantitation of TEX surface proteins and intra-vesicular microRNAs
on a single device. The Exo-PROS assay has shown superior sensing
performance than ELISA and qRT-PCR. The potential application
of Exo-PROS assay has been demonstrated in lung cancer early
detection.
9:00 Direct Kinetic Fingerprinting and Digital Counting of
Single Cancer Biomarker Molecules in Human Biofluids and
Single Cells
Nils Walter, PhD, Francis S. Collins Collegiate Professor of Chemistry,
Biophysics & Biological Chemistry; Founding Director, Single Molecule
Analysis in Real-Time (SMART) Center; Founding Co-Director of the
Center for RNA Biomedicine; Chemistry, University of Michigan
The sensitive and accurate quantification of specific cancer
biomarkers plays important roles in medical diagnostics and
research. We have developed a kinetic fingerprinting approach with
dynamically binding probes for the direct, digital, hyper-accurate
detection and counting of diverse single biomarker molecules in
complex biofluids, including blood serum, urine and in situ, with
femtomolar to attomolar limits of detection (LODs). We are currently
working to commercialize our technology, termed SiMREPS (single-
molecule recognition through equilibrium Poisson sampling).
9:30 Third-Generation Liquid Biopsy: A Comprehensive
Characterization of Circulating Analytes for Patient-Centered
Cancer Research
Peter Kuhn, PhD, Director, USC Michelson CSI-Cancer; Dean’s
Professor of Biological Sciences; Professor of Biological Sciences,
Medicine, Biomedical Engineering, and Aerospace and Mechanical
Engineering, University of Southern California
As cancer care is transitioning to personalized therapies with
necessary complementary or companion biomarkers, there is
significant interest in determining to what extent non-invasive liquid
biopsies reflect the gold standard solid biopsy. We have established
an approach for measuring patient-specific circulating and solid
cell concordance by introducing tumor touch preparations to the
high-definition single-cell analysis workflow for high-resolution
cytomorphometric characterization. Patient-specific level of
concordance can readily be measured to establish the utility of
circulating cells as biomarkers and define biosignatures for liquid
biopsy assays.
1:45 End of Enabling Technologies for Liquid Biopsy

TABLE OF CONTENTS
CHI’S INAUGURAL | AUGUST 26-27, 2020
ASSESSING OPPORTUNITY AND OVERCOMING CHALLENGES
Viewing
OVERVIEW
2:15 Overcoming the Challenges to Realize the
Opportunities of Early Disease Detection
John Sninsky, PhD, Independent Consultant, Translational Medicine
and Science
Diagnosis early in the natural history of disease promises to lead to
improved health management. However, over diagnosis needs to be
avoided. Valuable lessons learned from cancer will be instructive
for other chronic diseases. The integration of Information from
multiple disparate biological compartments to generate informative
probabilistic models will be paramount. How the healthcare system
determines applicable evidence level and rewards value with
reimbursement will be critical.
DATA AND ECONOMIC ANALYSIS
2:50 JAMA Users’ Guides to the Medical Literature: How to
Read Articles That Use Machine Learning
Yun Liu, PhD, Senior Research Scientist, Google Health
Many recent clinical diagnostic tools have been developed using
machine learning and must be evaluated using a 3-step process
of deriving, validating, and establishing the clinical effectiveness
of the tool. Several key considerations are appropriate machine
learning methods used for the type and size of data, proper tuning
of prespecified settings (called hyperparameters) on a dataset
independent of the final validation set, and a rigorous reference
standard.
3:20 Technology Valuation in the Era of Value-Based
Incentives for Physician Services
John Hornberger, MD, MS, Adjunct Clinical Professor of Medicine,
Stanford University
The U.S. has the highest per capita healthcare costs, with substantial
financial and clinical variability due to over- and under-use of
mispriced technologies (“moral hazard”). Physician-led professional
societies are creating/owning quality metrics for assessing
performance. Under MACRA, performance also is assessed based
on costs for an episode of care. To succeed under these new
incentives, physicians will need risk-based algorithms assessing
technology quality and costs; representative examples to be
presented.
Viewing
REIMBURSEMENT
and Science
5:10 Medicare: Adapting Prevention Policy for a New
Molecular Era
Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates LLC
Medicare has historically been far behind the curve in providing
coverage for preventive services, especially novel diagnostic tests.
Medicare’s approach is so slow, it risks actually discouraging
investing because of the long and slow policy pipeline. Medicare
can adopt new preventive benefits for diagnostics if they are
directly legislated by Congress. In addition, Medicare can adopt new
diagnostics through the year-long National Coverage Determination
(NCD) process, if they have been previously endorsed by the U.S.
Preventive Services Task Force. These serial steps can add many
years to the adoption of new technology and depend on irregular
multi-year timelines in the case of USPSTF. We will discuss the pros
and cons of the status quo, best practices, and case studies for
coping with the status quo, and the outlook for new policy that would
better encourage much-needed innovations.
5:40 Lessons Learned and Challenges of Reimbursement for
Paul Gerrard, MD, CMO & MolDX Director of Clinical Science, MolDx
Palmetto
6:40 Close of Day
THURSDAY, AUGUST 27
Breakfast
OPPORTUNITIES AND CHALLENGES OF EARLY
DIAGNOSIS OF DISEASE
and Science
8:30 KEYNOTE PRESENTATION: Overdiagnosis and
Premature Treatment Challenge of Early Disease
Detection
Laura Esserman, MD, MBA, Professor, Surgery, University of
California San Francisco Medical Center
9:00 Multi-Modal Approaches to Early Disease Detection and
Population-Based Screening
Drew Watson, MBA, PhD, Biostatistics and Clinical Development Advisor
For many diseases, population screening is essential to improving
patient survival. Despite the promise of blood-based “liquid
biopsies”, progress has been limited necessitating new multi-omics
approaches incorporating multiple technologies. We discuss new
approaches to biomarker discovery, algorithm development, and
clinical validation using mechanistic, statistical, and machine
learning approaches for handling of multi-omics data. We further
discuss the need to improve clinical decision support systems to
facilitate clinical decision making.
9:30 Epigenetic Genomic Modifiers as Proxies of Gene
Expression for Cancer
Alex Aravanis, MD, PhD, CSO, Head, R&D; Co-Founder, GRAIL

TABLE OF CONTENTS
EARLY DETECTION OF DISEASE, continued
OPPORTUNITIES AND CHALLENGES OF EARLY
DIAGNOSIS OF DISEASE (CONT.)
and Science
11:10 Opportunity for Pre-Competitive Multi-Stakeholder
Collaboration for NAFLD Detection and Intervention
Veronica Miller, PhD, Executive Director, Forum for Collaborative
Research; Professor (Adjunct), UC Berkeley SPH
Non-alcoholic fatty liver disease (NAFLD) affects approximately
25% of adults and 10% of children in the U.S. and is associated with
obesity, type 2 diabetes mellitus, dyslipidemia and hypertension.
Severe clinical outcomes include decompensated cirrhosis and
hepatocellular carcinoma. The current diagnostic standard for
non-alcoholic steatohepatitis (NASH), the more advanced form of
NAFLD, is based on liver biopsies. Early diagnosis of the higher risk
individuals is paramount. Representation and active engagement of
scientific experts from all stakeholder groups in a non-competitive
environment increases clarity and standardization while decreasing
uncertainty. Lessons learned will be summarized.
11:25 Breast Cancer Overdiagnosis and the Precancer
Problem
Alexander Borowsky, PhD, Associate Professor, Department of
Pathology and Laboratory Medicine, University of California, Davis
Breast cancer screening by mammography, which began in the
U.S. about 40 years ago, has led to significant increases in the
incidence of early-stage breast cancers, including ductal carcinoma
in situ (DCIS), also called precancer or stage 0 disease. However,
the expected reciprocal decrease in subsequent late-stage breast
cancers was not found. It is now clear that some screen-detected
breast “cancers” are indolent lesions without significant malignant
potential.
11:40 Challenges of CT Lung Screening Implementation
Andrea McKee, MD, President, Rescue Lung, Rescue Life Society;
Chairman, Radiation Oncology, Lahey Hospital & Medical Center
Discussion of challenges and lessons learned from implementation
of one of the largest clinical and biomarker research-integrated
CT lung screening programs in the United States. Review of
infrastructure required for local implementation success. Exploration
of cultural and societal transformation necessary for widespread
lung screening adoption.
11:55 PANEL DISCUSSION: Opportunities and Challenges of
Early Diagnosis of Disease
Moderator: John Sninsky, PhD, Independent Consultant, Translational
Medicine and Science
Panelists:
Alexander Borowsky, PhD, Associate Professor, Department of
Pathology and Laboratory Medicine, University of California, Davis
Andrea McKee, MD, President, Rescue Lung, Rescue Life Society;
Chairman, Radiation Oncology, Lahey Hospital & Medical Center
Veronica Miller, PhD, Executive Director, Forum for Collaborative
Research; Professor (Adjunct), UC Berkeley SPH
12:35 pm Sponsored Presentation (Opportunity Available)
Viewing
EARLY DETECTION OF CANCER AND BEYOND
Abhijit Patel, MD, PhD, Associate Professor, Yale University School of
Medicine
2:20 Saliva Liquid Biopsy
David Wong, DMD, DMSc, Associate Dean of Research, Felix & Mildred
Yip Endowed Distinguished Professor, UCLA School of Dentistry
Saliva is a bodily fluid that we produce ~600ml per day and harbors
multiple omics constituents that can be harnessed non-invasively
and painlessly for personalized and precision medicine, making it
ideal for liquid biopsy applications. Yet, PCR-based technologies
cannot detect ctDNA in saliva samples, whereas an emerging liquid
biopsy platform “Electric Field Induced Release and Measurement
(EFIRM)” can consistently detect ctDNA from NSCLC patients with
actionable mutations in plasma and saliva with concordance of
95%+ with tissue/biopsy-based genotyping, including early stage
lesions.
2:50 Plasma-Based Liquid Biopsies for Early Detection of
Cancer
Nickolas Papadopoulos, PhD, Professor, Oncology and Pathology,
Director of Translational Genetics, Ludwig Center for Cancer Genetics
& Therapeutics, Sidney Kimmel Comprehensive Cancer Center, The
Johns Hopkins Institutions
Early detection of cancer has the potential to significantly reduce
cancer deaths. Liquid biopsies provide an opportunity to develop
tests for the detection of multiple-types of cancer in a single test. We
will discuss the opportunities and the challenges of developing and
utilizing such test.
EARLY DETECTION OF CANCER AND BEYOND
(CONT.)
Chairperson’s Remarks
Cesar Martin Castro, MD, Director, Cancer Program; MGH Center for
Systems Biology, Massachusetts General Hospital/Harvard Medical
School
3:20 The Advantages and Challenges of Liquid Biopsies for
Early Cancer Detection and Screening
Lynn Sorbara, PhD, Program Director, Cancer Biomarkers Research
Group, National Cancer Institute (NCI), NIH
Clinical decisions are increasingly being guided by diagnostic
workups, including imaging and tissue biopsies. Although tissue
biopsy remains the mainstay of diagnostics, there are continuing
efforts to develop non-invasive tests that could be adopted for
samples acquired with minimum discomfort to patients. Liquid
biopsies may be of great importance, particularly when organs
of interest may not be accessible, or the patient may have other
health conditions that prevent them from undergoing the procedure.
These non-invasive or minimally invasive procedures may afford an
opportunity to detect lesions in cases where tissue biopsy may be
difficult or impossible. To date, the use of liquid biopsy in cancer risk
assessment and early detection has remained at the periphery. Most
of the research on liquid biopsies use blood and blood products;
however, other biofluids, such as urine, sputum, saliva, stool, and
cervical-vaginal fluids are being investigated. Despite all of the
advantages of liquid biopsy assays, there are many challenges
to overcome for successful validation and widespread use in the
setting of early detection and screening.
3:50 Leveraging Novel Exosome Nanosensors for Earlier
Pancreatic Cancer Detection
Cesar Martin Castro, MD, Director, Cancer Program; MGH Center for
Systems Biology, Massachusetts General Hospital/Harvard Medical
School
Exosomes reflect promising cancer biomarkers due to their
abundance in biofluids, protein, and RNA contents reflecting parental
cells, and stability in circulation. Pancreatic ductal adenocarcinomas
(PDAC) represent highly lethal cancers often presenting at advanced
stages. Integrating exosomes into monitoring programs for PDAC
could improve clinical outcomes. This talk will discuss novel
nanosensors we developed to analyze exosomes in blood and recent
translational strategies to position them into clinical workflows.
4:20 End of Summit

TABLE OF CONTENTS
CONFERENCE STREAMS
AUGUST 25-26
AGENDA Drug-Diagnostics Co-Development
& Companion Dx
AUGUST 26-27
AGENDA
Immuno-Oncology Biomarkers
and Diagnostics
2020 COMPANION DX & IO BIOMARKERS CONFERENCES
Companion DX &
IO Biomarkers Stream
BUSINESS
NGS ADVANCES

CHI's Next Generation Dx Summit | August 25-27, 2020 | Washington, DC

CHI's Next Generation Dx Summit | August 25-27, 2020 | Washington, DC

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CHI's Next Generation Dx Summit | August 25-27, 2020 | Washington, DC