CHI's Next Generation Dx Summit 2022 | August 22-24, 2022 | Washington, D.C.

PREMIER SPONSORS
TABLE OF CONTENTS
Cynthia A. Bens
Personalized Medicine
Coalition
Jeff Allen, PhD
Friends of Cancer Research
Sarah Thibault-Sennett, PhD,
Association for Molecular
Pathology
Lauren R. Silvis, PhD
Tempus, Inc.
Thomas Sparkman, JD
American Clinical Laboratory
Association
Susan Van Meter
AdvaMed
Franklin R. Cockerill III, MD
Rush University
Karen A. Heichman, PhD
Bill & Melinda Gates
Foundation
Jack Jeng, MD, MBA
BD Biosciences
Elizabeth M. Marlowe, PhD,
D(ABMM)
Quest Diagnostics Nichols
Institute
Donna M. Wolk, PhD
Geisinger Health System
Nicole Zitterkopf, PhD,
D(ABMM), MPH, MT(ASCP)
OptumHealth
NextGenerationDX.com
#NGDx22
Register Early for
Maximum Savings!
PLENARY
KEYNOTE SPEAKERS
ADVANCING DIAGNOSTICS TOGETHER
AUGUST 22-24, 2022 | WASHINGTON, D.C.
Grand Hyatt Washington, D.C. & Virtual
2022 CONFERENCE PROGRAMS
■ Drug-Diagnostic Co-Development and
Companion Diagnostics
■ Coverage and Reimbursement for Advanced
Diagnostics
■ Liquid Biopsy for Disease Management
■ Early Cancer Surveillance
■ Enabling Point-of-Care Diagnostics
■ Advanced Diagnostics for Infectious Disease
POC and Infectious Disease
Companion Dx and Reimbursement
Liquid Biopsy and Early Detection

Table of Contents
VIEW ABOUT THE SUMMIT
VIEW CONFERENCE AT-A-GLANCE
VIEW PLENARY KEYNOTE PRESENTERS
VIEW SHORT COURSES
VIEW POSTERS
VIEW 2022 SPONSORS
VIEW MEDIA PARTNERS
VIEW HOTEL & TRAVEL
VIEW SPONSOR & EXHIBIT INFORMATION
VIEW REGISTRATION INFORMATION
AUGUST 22-24, 2022 | GRAND HYATT WASHINGTON, D.C. | WASHINGTON, D.C.
IN-PERSON & VIRTUAL
14th
AnnualNext
2022 CONFERENCE PROGRAMS
Liquid Biopsy for
Disease Management
Early Cancer
Surveillance
Enabling Point-of-Care
Diagnostics
Advanced Diagnostics for
Infectious Disease
Drug-Diagnostic
Co-Development and
Coverage and Reimbursement
for Advanced Diagnostics
To ensure maximum safety, CHI has instituted mandatory health and safety protocols for all attendees,
exhibitors, speakers and staff who attend in person. All in-person attendees must provide proof of full
vaccination against COVID-19. You will be asked to present your vaccination card (or a photo of it) at
registration. We are actively following news and recommendations around COVID-19 and the Omicron
variant. These protocols are subject to change as we continue to learn more.
Attendees who cannot participate because of this policy, or due to travel restrictions, are encouraged to
participate using our highly-praised virtual event platform. Our virtual events are designed to provide you
with an in-person experience at your convenience, anywhere, anytime.
Your Safety is Our Top Priority
CHI’S MANDATORY COVID-19 VACCINATION POLICY
POC and Infectious
Disease Stream
Companion Dx and
Reimbursement Stream
Liquid Biopsy and
Early Detection Stream
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CONTENTS
#NGDx22
2 | NextGenerationDx.com

About the Event
We are proud to host Cambridge Healthtech Institute’s 14th Annual Next Generation Dx
Summit which will take place in-person at the Grand Hyatt Washington, D.C., on August
22-24. The Next Generation Dx Summit is the nexus for key opinion leaders across the
world to share recent progress in diagnostic advancement and technology innovation. The
event provides a valuable window on how point-of-care, infectious disease, liquid biopsy
and companion diagnostics are changing the standard of care. Now in its fourteenth year,
the Next Generation Dx Summit is a must-attend event with complete coverage of the most
timely and important topics for the industry. Benefits of attending include:
• Form partnerships with major players in the evolving areas of diagnostics
• Gain a comprehensive, up-to-date view of diagnostics, including the latest rapid and
molecular diagnostics for COVID-19
• Gather important industry announcements
• Hear late-breaking news on lessons learned from COVID-19 testing
• Review innovative products and novel platforms and technologies in the exhibit hall and
the poster session
“I was able to get a big-picture outlook
at the technologies and challenges
in the
diagnostics world! The networking
opportunities were fantastic.”
Senior Product Training Specialist, Millipore Sigma
Conference At-A-Glance
Monday Aug. 22 Tuesday AM, Aug. 23 Tuesday PM Aug. 23 Wednesday, Aug. 24
STREAM
Enabling Point-of-Care
Diagnostics
Drug-Diagnostic
Co-Development and
Liquid Biopsy for Disease
Management
Infectious Disease
Early Cancer Surveillance
POC and Infectious
Disease Stream
Companion Dx and
Liquid Biopsy and Early
Detection Stream
TABLE OF
CONTENTS
#NGDx22

2022 SPONSORS
CORPORATE SUPPORT SPONSORS
CORPORATE SPONSORS
PREMIER SPONSORS
SUMMIT
TABLE OF
CONTENTS
#NGDx22

Jon Stroup
Senior Business Development Manager
781-972-5483
jstroup@healthtech.com
FOR MORE INFORMATION REGARDING EXHIBIT
AND SPONSORSHIP, PLEASE CONTACT:
n Biotech................................49%
n Healthcare..........................16%
n Pharma..................................9%
n Academic..............................9%
n Government..........................8%
n Societies...............................5%
n Services.................................3%
n Other......................................1%
COMPANY TYPE
2021 ATTENDEE DEMOGRAPHICS
n East Coast..............50%
n West Coast............34%
n Midwest.................16%
n USA........................84%
n Europe...................10%
n Asia.........................5%
n Rest of World..........1%
GEOGRAPHIC
LOCATION
USA
SPONSORSHIP PROGRAMS
CHI’s comprehensive sponsorship packages allow you to achieve your objectives before, during, and long after the
event. Maximize exposure to hard-to-reach decision-makers through the following sponsorship opportunities:
n Executive........................21%
n Director...........................20%
n Scientist/
Technologist.................20%
n Sales Marketing.........19%
n Manager.........................10%
n Professor.........................8%
n Assistant..........................2%
DELEGATE TITLE
An exciting new feature has been added to the Exhibit Hall at this year’s
Next Generation Dx Summit: It’s called ‘Meet the Expert,’ and essentially,
it’s a booth where Conference Delegates can meet with scheduled
experts and engage them in discussion. Throughout the Exhibit Hall hours, a booth
has been dedicated to feature a series of ‘Experts’ who are available to share their
insights and important work. Experts will primarily be session speakers, but will also
include journalists and other experts, including some CHI staff.
ADDITIONAL BRANDING
PROMOTIONAL OPPORTUNITIES
INCLUDE:
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, or lunch. Package includes exhibit
space, on-site branding, and access to cooperative marketing
efforts by CHI. For the luncheon option, lunches are delivered to
attendees already seated in the main session room. Presentations
do sell out early.
PODIUM PRESENTATIONS INVITATION-ONLY 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, conduct follow-up and confirm attendees. The
evening will be customized to meet with your specific objectives.
MEET THE EXPERT
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!
LOOKING FOR ADDITIONAL WAYS TO DRIVE LEADS
TO YOUR SALES TEAM?
• Literature Distribution (Tote Bag
Insert or Chair Drop)
• Padfolios
• Conference Material Advertisements
• Hotel Room Keys
• Footprint Trails
• Conference Tote Bags
• Badge Lanyards
ONE-ON-ONE MEETINGS
Work with us to identify your target prospects and
we will schedule meetings for you. Think of us as
your inside sales team with all your hottest leads in close reach.
Opportunities sold on a very limited basis.
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CONTENTS
#NGDx22

Available for in-person attendees only
Dinner Short Courses*
*Separate registration required. Short courses are available for in-person
attendees only.
SUMMIT
“We were very impressed
by the informative speakers,
meaningful diverse content
brilliant networking
opportunities. To set up 121
meetings during
the event via
the app just made
the event
exceptional.”
Sales Marketing, z-microsystems
SC1: Navigating the EUA Process for
Diagnostics
Instructors: B. Melina Cimler, PhD, CEO Founder, PandiaDx LLC
Alberto Gutierrez, PhD, Partner, NDA Partners LLC
Gail Radcliffe, PhD, President, Radcliffe Consulting, Inc.
This course will cover: access to samples, real world data, CLIA status
for POCT, lessons learned and transition period after the pandemic,
serological testing, the importance of reliance on international regulatory
oversight, the need for transparency, metrics, and predictability,
what the impact is on everything else and how the agency will deal
with the backlog.
SC2: Impact of CMS Rate-Setting on Access for
Novel Tests
Instructor: Nicholas M. Halzack, MPH, Senior Manager, Health Policy
Reimbursement, Roche Diagnostics Corporation North America
TUE, AUG 23, 2022 | 6:30 PM TO 8:30 PM
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PANEL MODERATOR:
Franklin R. Cockerill III, MD, Founding Partner, Trusted Health Advisors;
Adjunct Professor, Medicine, Rush University
PANELISTS:
Karen A. Heichman, PhD, Deputy Director, Bill Melinda Gates
Foundation
Jack Jeng, MD, MBA, Director, Medical Affairs, BD Biosciences
Elizabeth M. Marlowe, PhD, D(ABMM) Senior Scientific Director, Head
RD Infectious Diseases Immunology, Quest Diagnostics Nichols
Institute
Donna M. Wolk, PhD, Chief, Molecular Microbial Diagnostics
Development, Geisinger Health System
Nicole Zitterkopf, PhD, D(ABMM), MPH, MT(ASCP), Vice President
Laboratory, Service Line Advancement Team, OptumHealth
TUESDAY, AUGUST 23
Plenary Keynote Sessions
Co-Organized with
Cynthia A. Bens
Personalized
Medicine Coalition
Jeff Allen, PhD
Friends of Cancer
Research
Sarah Thibault-
Sennett, PhD,
Association for
Molecular Pathology
Lauren R. Silvis,
PhD
Tempus, Inc.
Thomas Sparkman,
JD American
Clinical Laboratory
Association
Susan Van Meter
AdvaMed
Franklin R. Cockerill
III, MD
Rush University
Karen A.
Heichman, PhD
Bill Melinda Gates
Foundation
Jack Jeng, MD,
MBA
BD Biosciences
Elizabeth M.
Marlowe, PhD,
D(ABMM)
Quest Diagnostics
Nichols Institute
Donna M. Wolk, PhD
Geisinger Health
System
Nicole Zitterkopf,
PhD, D(ABMM),
MPH, MT(ASCP)
OptumHealth
PANEL DISCUSSION I:
Legislative Efforts to Modernize
Diagnostic Oversight
PANEL DISCUSSION II:
Self-Testing – Applying What We
Have Learned from the Pandemic for
Future Applications
PANEL MODERATOR:
Cynthia A. Bens, Senior Vice President, Public Policy, Personalized
Medicine Coalition
PANELISTS:
Jeff Allen, PhD, Executive Director, Friends of Cancer Research
Sarah Thibault-Sennett, PhD, Director, Public Policy Advocacy,
Association for Molecular Pathology
Lauren R. Silvis, PhD, Senior Vice President, External Affairs, Tempus, Inc.
Thomas Sparkman, JD, Senior Vice President, Government Affairs and
Policy, American Clinical Laboratory Association
Susan Van Meter, Executive Director, AdvaMed
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CONFERENCE STREAMS
2022 POC AND INFECTIOUS DISEASE
CONFERENCES
AUGUST 22-23
Enabling Point-of-Care Diagnostics
AGENDA
AUGUST 23-24
Infectious Disease
AGENDA
POC and Infectious
Disease Stream
The Point-of-Care and Infectious Disease stream focuses on the latest
technologies and applications of POCT and rapid diagnostics for
emerging and existing diseases. State-of-the-art devices and testing
methods will be highlighted along with strategies to move diagnostics
to the clinic and through reimbursement hurdles. Innovation at the
point-of-care including IoT and wearables will be featured.
POC and Infectious
Disease Stream
Companion Dx and
Liquid Biopsy and
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POC AND
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CHI’S 16TH ANNUAL | AUGUST 22-23, 2022
Accelerating Rapid Testing for at-Home, Clinical Labs, and Pharmacy Settings
Sunday, August 21
1:00 pm Conference Registration Open
Monday, August 22
7:15 Registration and Morning Coffee
AT-HOME TESTING AND SAMPLE COLLECTION
8:25 Chairperson’s Remarks
Lawrence Worden, Founder, Principal, IVD Logix
8:30 KEYNOTE PRESENTATION: Overcoming the
Limitations of Current Point-of-Care Testing
Methods – What the Future Holds for Diagnostics
Timothy Still, CEO, Sense Biodetection Ltd.
This talk will provide an overview of the current point-of-care (POC)
diagnostic testing landscape and the limitations of current methods. He
will examine how throughput, accuracy, and speed are of high value to
healthcare clinically, operationally, and economically, and how this new
technology can help to improve population health.
9:00 At-Home Testing: An Inflection Point for Adoption and Utility
Jordan S. Laser, MD, Medical Director, Department of Pathology and Laboratory
Medicine; LIJMC; Associate Medical Director, Core Laboratories; Director, Division
of Near Patient Testing, Northwell Health; Associate Professor, Donald and
Barbara Zucker School of Medicine, Hofstra/Northwell
The pandemic has catapulted virtual care and at-home testing into the forefront
of medicine. Many Americans have learned to manage their health virtually, but
health cannot be properly managed without the critical datapoint from clinical
laboratories. During this session, we will explore the landscape of at-home-
testing, which will include both at-home collection of clinical samples to be
mailed to clinical laboratories and point-of-care devices resulted in the home.
9:30 COVID-19 Catalyzed Acceleration in Mail-in Self-Collected
Samples for Sexually Transmitted Infection Testing
Yukari Manabe, MD, Associate Director of Global Health Research and Innovation,
Professor of Medicine, Johns Hopkins Medicine
COVID-19 has resulted in major disruptions in STI services, including
diagnostic testing. Many public health clinics closed or severely curtailed
in-person visits in lieu of telemedicine. The lack of walk-in services likely led
to under-ascertainment of STI’s. During that period, self-collected mail-in
specimen laboratory-based testing has increased dramatically for both STIs
and COVID-19. Over-the-counter diagnostic testing for COVID-19 will also be
discussed and its implications for future STI OTC testing.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
10:45 Adapting to Home Testing and Remote Sample Collection: The
View from the Clinical Laboratory
Elizabeth M. Marlowe, PhD, D(ABMM) Senior Scientific Director, Head RD
Infectious Diseases Immunology, Quest Diagnostics Nichols Institute
The SARS-CoV-2 pandemic impacted healthcare delivery systems and
accelerated alternative delivery strategies. Remote specimen collection with
samples sent to a central laboratory as well as at home testing options have
shifted the paradigm in the patient journey. The goal of this talk is explore
how clinical laboratories are pivoting to meet the needs of alternative delivery
strategies for testing and the impact on the central laboratory.
11:15 The Role of Online Testing Programs in Support of at-Home
Test Development
Karen Tegan Padir, MBA, Vice President, Digital Product Technology, Binx
Health
The COVID-19 pandemic has expanded the market for self-diagnostic products
by accelerating consumers’ willingness to test for more medical conditions
at home. However, some medical professionals are still reluctant to embrace
at-home testing. In this session, we will examine the barriers to implementing a
near patient lab-based diagnostic testing program and tools and technology to
overcome those objections.
11:45 Talk Title to be Announced
Speaker to be Announced
12:15 Luncheon Presentation to be Announced
12:45 LUNCHEON PRESENTATION: High-Sensitivity
Microfluidic SARS-CoV-2 Immunoassay in a
Community Pharmacy
Nicole Schreiner, Clinical Services Manager/Owner, Pharmacy, Streu’s Pharmacy
Novel technologies now enable lab-comparable testing to be performed in
point-of-care settings. Learn how implementation of the LumiraDx Platform in
an independent community pharmacy contributed to community care in Green
Bay, WI. LumiraDx, a next-generation diagnostics company, is transforming
community-based healthcare. The LumiraDx Platform combines a small, easy-
to-use, and portable instrument with an innovative microfluidic test strip to
deliver high-sensitivity rapid antigen testing.
1:15 pm Session Break
POC FOR DELIVERING TESTING FOR
UNDERSERVED POPULATIONS: OUT OF THE
HOSPITAL AND INTO THE COMMUNITY
James Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology and
Immunology, Medical Director, Clinical Chemistry and POCT, Vanderbilt University
School of Medicine
1:35 KEYNOTE PRESENTATION: How Do I Get a
COVID-19 Test in California (aka Building an
Airplane while in Flight)
Valerie L. Ng, MD, PhD, Chair of Laboratory Medicine
Pathology, and Director of Transfusion Services, Clinical Laboratories,
Alameda Health System
The answer depends on when you wanted to be tested. This talk will
review the COVID-19 testing experience in California since the beginning
of the pandemic (March 2020). I will review the rapid development and
scale-up of conventional clinical laboratory and point-of-care testing,
creation and expansion of outreach efforts for underserved communities,
collaboration of federal/state/local healthcare systems, and helping the
inexperienced with regulatory compliance.
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POC AND
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DISEASE
CONTINUED
2:05 Point-of-Care Kidney Disease Screening in Remote
Communities: A Tool for Healthcare Equity
AbdulRazaq A.H. Sokoro, PhD, Executive Director, Provincial Laboratory
Operations Diagnostic Services, Shared Health, Inc.
Health care equity is a cornerstone of healthy communities. Access to
diagnostic care is critical to disease management in communities. This
presentation will provide overview of a project launched to provide essential
diagnostic testing for screening chronic kidney disease in remote communities
in Manitoba, Canada, using point-of-care devices. The laboratory services
provided meets laboratory quality requirements while allowing for its
administration in non-lab setting, thereby ensuring access to care.
2:35 At the Corner of Access and Quality: Community Pharmacy as a
Public Health Destination
Kenneth C. Hohmeier, PharmD, Associate Professor, Director of Community
Affairs, PGY-1 Community-Based Pharmacy Residency Program, The University of
Tennessee Health Science Center
The COVID-19 pandemic has accelerated the pace at which point-of-care
(POC) testing is being adopted in the community pharmacy setting. Increasing
numbers of community pharmacies are interested in developing their POC test
and treat programs, including large pharmacy chains, as the US increasingly
looks to this setting as a public health destination. After two years of the
pandemic, the question is not if community pharmacy will adopt, but how.
3:05 Refreshment Break in the Exhibit Hall with Poster Viewing
3:45 What Policymakers Have in the Works for POCT
Vince Stine, PhD, Director, Government Affairs, American Association for Clinical
Chemistry
In recent years, point-of-care testing has expanded rapidly. POCT is increasingly
performed in a variety of care settings, ranging from hospitals and physicians’
offices to pharmacies, assisted living facilities, and patients’ homes. Learn
what policy options legislators and regulators are considering as they seek
to balance patient access to testing with the need to assure the tests are
accurate and useful.
4:15 Innovative Clinical Applications of POCT in Different Settings
James Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology and
Immunology, Medical Director, Clinical Chemistry and POCT, Vanderbilt University
School of Medicine
With the COVID pandemic, traditional POCT options in the hospital and clinics
have expanded POCT use into the community with pharmacy testing, visiting
nurses, and doctor on-call services providing more personalized patient care.
POCT is being conducted at sports, concerts, and other events. At-home self-
testing is increasing with reliance on remote doctor visits and telehealth. This
session will explore the various ways that POCT is being utilized in healthcare.
5:00 Sponsored Presentation (Opportunity Available)
5:15 Wine and Cheese Pairing Welcome Reception in the Exhibit Hall
with Poster Viewing
6:30 Close of Day
Tuesday, August 23
7:15 Registration Open
7:30 Breakout Discussions with Continental Breakfast
Breakout Discussions are informal, moderated discussions, allowing participants
to exchange ideas and experiences and develop future collaborations around
a focused topic. Each discussion will be led by a facilitator who keeps the
discussion on track and the group engaged. To get the most out of this format,
please come prepared to share examples from your work, be a part of a
collective, problem-solving session, and participate in active idea sharing. Please
visit the Interactive Discussion page on the conference website for a complete
listing of topics and descriptions.
At-Home Testing: An Inflection Point for Adoption and Utility
Jordan S. Laser, MD, Medical Director, Department of Pathology and Laboratory
Medicine; LIJMC; Associate Medical Director, Core Laboratories; Director, Division
of Near Patient Testing, Northwell Health; Associate Professor, Donald and
Barbara Zucker School of Medicine, Hofstra/Northwell
NEXT-GENERATION POC TECHNOLOGIES
David Giles, Senior Director, Medical Devices, Battelle Memorial Institute
8:30 Next-Generation Molecular Detection
Tara Dalton, PhD, Assistant Director, Stokes Research Institute, Department of
Mechanical and Aeronautical Engineering, University of Limerick
We present an alternative to PCR for the detection and quantification
of molecular targets. The method – Detection by Proxy – combines
nanotechnology, microfluidics, and semiconductors in a unique way that
facilitates molecular detection outside a clinical setting.
9:00 Antifouling Coating Enables Multiplexed
Electrochemical Diagnostics
Pawan Jolly, PhD, Senior Staff Scientist II, Advanced Technology Team;
Sensors Team Lead – Bioinspired Therapeutics and Diagnostic Platform (BTD);
Technology Lead, Wyss Diagnostics Accelerator (Wyss DxA), Harvard University
We developed a platform that enables multi-omics analysis. The technology
is based on an electrochemical platform that can multiplex and use samples
without any processing. The technology also enables CRISPR electronics
coupled with protein detection.
9:30 Exposure Health Epigenetic Diagnostic Biomarker Discovery
Rachel Spurbeck, PhD, Senior Genomics Research Scientist, Health Outcomes
and Biotechnology Solutions, Battelle Memorial Institute
The epigenome is the molecular link between the environment and the genome
causing different phenotypes to be expressed due to environmental stimuli. By
understanding epigenetics, one can identify chemical or biological exposures
affecting health. We present a platform for diagnostic target identification
to enable rapid development of diagnostic tests for exposure health. These
markers are being developed into diagnostic assays to rapidly identify
exposures to prevent or treat illness.
11:00 Registration Open for Part B Tracks
11:15 Transition to Plenary Keynote
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POC AND
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DISEASE
CONTINUED
11:25 Plenary Panel Introduction
Cynthia A. Bens, Senior Vice President, Public Policy,
Personalized Medicine Coalition
11:30 Panel Discussion I: Legislative Efforts to Modernize
Moderator: Cynthia A. Bens, Senior Vice President, Public Policy,
•
Why has there been a sustained, multi-year push for legislation to
modernize the regulatory and oversight landscape for diagnostics?
•
How will leading legislative proposals, like the Verifying Accurate
Leading-edge IVCT Development (VALID) Act, change diagnostics
regulation and oversight? What impacts will these changes have on the
diagnostics industry and on patient care?
Panelists:
12:15 Panel Discussion II: Self-Testing – Applying What We
Have Learned from the Pandemic for Future Applications
Moderator: Franklin R. Cockerill III, MD, Founding Partner, Trusted Health
Advisors; Adjunct Professor, Medicine, Rush University
•
In your opinion, what is the single most important advance in diagnostic
testing that has occurred with the COVID-19 pandemic?
•
What are the pluses and minuses of self-swabbing for respiratory
viruses (can be other specimen sources for self-collections,
e.g., HPV, STD)?
•
What are the pluses and minuses of self-testing for respiratory viruses
(e.g., COVID self-testing antigen tests)?
Panelists:
Karen A. Heichman, PhD, Deputy Director, Bill Melinda Gates Foundation
1:00 pm Luncheon Presentation (Sponsorship Opportunity Available)
or Enjoy Lunch on Your Own
2:00 Close of Enabling Point-of-Care Diagnostics Conference
6:30 Recommended Dinner Short Courses*
SC1: Navigating the EUA Process for Diagnostics
SC2: Impact of CMS Rate-Setting on Access for Novel Tests
*Short Courses will be offered in-person only. Separate registration required.
See short course page for details.
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Advanced Diagnostics for Infectious Disease
Improving Clinical Outcomes through Novel Technologies and Molecular Testing
Tuesday, August 23
•
•
Panelists:
•
•
e.g., HPV, STD)?
•
Panelists:
NGS AND BEYOND
Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and Medical Director,
Medical College of Wisconsin
2:20 KEYNOTE PRESENTATION: Experience with
Targeted Metagenomic Sequencing in Medical
Practice
Robin M. Patel, MD, D(ABMM), FIDSA, FACP, F(AAM),
FRCPC, Elizabeth P. and Robert E. Allen Professor of Individualized
Medicine; Director, Infectious Diseases Research Laboratory, Professor
of Medicine and Microbiology, Co-Director, Bacteriology Laboratory;
Vice Chair of Education, Department of Laboratory Medicine and
Pathology, Mayo Clinic
In this presentation, the Mayo Clinic experience with targeted
metagenomic sequencing of the 16S ribosomal RNA gene in clinical
practice will be overviewed. The presentation will cover performance
of this type of testing on normally sterile body fluids (e.g., pleural fluid,
cerebrospinal fluid) and normally sterile tissues (e.g., heart valves).
Logistics of performing such testing clinically will be covered, as will the
incremental yield of NGS over Sanger sequencing.
2:50 Clinical Metagenomics: The Hype and the Hurdles
Benjamin Briggs, MD, PhD, CMO, CosmosID
Clinical metagenomics: a diagnostic in its infancy. While specific uses are
discovered, deployments engineered, case reports published; necessary
clinical evidence is lacking for broad uptake to be successful. In addition,
there are technological and methodological challenges which must be solved
before clinical metagenomics is mainstream. However, these obstacles will
be mitigated in clinical metagenomics as they have in other fields of medicine
encountering novel technologies, often earlier than optimistic projections.
3:20 Cases in the Application of Next-Generation Sequencing to
Detect Antimicrobial Resistance
Patricia Simner, PhD, D(ABMM), Associate Professor, Pathology, Director,
Bacteriology, Division of Medical Microbiology, Johns Hopkins University School
of Medicine
This talk will weigh the advantages and disadvantages of the various NGS
applications for detection of antimicrobial resistance, discuss the use of whole
genome sequencing to predict phenotypic antimicrobial susceptibility testing
and describe the status of applying targeted and metagenomic next-generation
sequencing to detect antimicrobial resistance.
4:30 Panel Discussion: Should Molecular or Antigen Testing Be Used
During Outbreaks of Emerging Infectious Diseases?
Moderator: Matthew Binnicker, PhD, Consultant, Division of Clinical Microbiology,
Vice Chair of Supply Chain Management, Department of Laboratory Medicine
and Pathology, Vice Chair of Practice, Mayo Clinic; Chair, ASM’s Professional
Development Subcommittee
Motion: Rapid antigen tests should be used as the primary screening assay
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POC AND
INFECTIOUS
DISEASE
during outbreaks of emerging infectious diseasesTeam arguing for the motion:
Mara Aspinall, Richard NoelTeam arguing against the motion: Susan Butler-
Wu, Linoj Samuel
Panelists:
Mara G. Aspinall, Managing Director, BlueStone Venture Partners, LLC
Richard Noel, Director, North America Marketing, LumiraDx USA, Inc.
Susan Butler-Wu, PhD, D(ABMM), SM(ASCP), Associate Professor of Clinical
Pathology, Keck School of Medicine of USC; Director, Clinical Microbiology
Laboratory, LAC+USC Medical Center
Linoj P. Samuel, PhD, Head, Clinical Microbiology, Henry Ford Hospital
6:00 Close of Day
6:00 Dinner Short Course Registration
Wednesday, August 24
Diagnostic Stewardship for Management of Point-of-Care Testing
Erin McElvania, PhD, D(ABMM), Director of Clinical Microbiology, NorthShore
University HealthSystem
•
What are some examples of when diagnostic stewardship can be helpful and
when it can be harmful?
•
Who is in charge of diagnostic stewardship for point-of-care testing at
your institution?
•
What are some successful stewardship strategies that have worked at your
institution and why?
•
What are some strategies that didn’t work and why?
DIAGNOSTIC STEWARDSHIP
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
8:30 Tailoring Antimicrobial Susceptibility Testing to Improve
Patient Outcomes
Romney M. Humphries, PhD, Professor, Pathology Microbiology Immunology,
Vanderbilt University
Antimicrobial Susceptibility Testing (AST) is one of the primary functions of
the clinical microbiology laboratory, and yet many laboratories take a ‘test and
report all’ approach to AST. This presentation will describe various strategies for
smart AST, from test methods, troubleshooting and reporting.
9:00 Optimizing Patient Care with Diagnostic Stewardship for Point-
of-Care Testing
Erin McElvania, PhD, D(ABMM), Director of Clinical Microbiology, NorthShore
University HealthSystem
Point-of-care testing provides rapid results which can be immediately used
for clinical decision making. It also can result in overuse, runaway costs,
and confusion when results differ from conventional testing. Diagnostic
stewardship is essential for management of point-of-care testing. This
presentation will highlight the benefits, limitations, and how we can best
steward point-of-care testing for maximum patient impact.
9:30 Host Response Strategies for Infectious Disease
Ephraim Tsalik, MD, MHS, PhD, Associate Professor, Medicine, Center for Applied
Genomics Precision Medicine, Duke University
The management of infectious diseases requires a holistic diagnostic strategy.
In conjunction with advances in pathogen detection, host response-based
tests provide a comprehensive understanding of a patient’s clinical state. A
combination of systems biology, machine learning, and integrated sample-to-
answer testing platforms has enabled the development of a growing number
of host response tests for infectious disease. Diagnostic stewardship will be
necessary to maximize these opportunities.
10:45 Things We Do, But Shouldn’t: Top 5 List of Useless
Microbiology Practices and How We Can Do Better
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
In the diagnosis of infectious diseases, we endeavor to deploy evidence-based
practices driven by the best available science. There are often gray areas
or gaps in the literature, which can lead to “controversy” and a diversity of
practices. In this lecture we will discuss five suboptimal practices in clinical
microbiology, and we can do better, both within the laboratory and through
laboratory stewardship programs.
11:45 Luncheon Presentation to be Announced
TABLE OF
CONTENTS
#NGDx22

POC AND
INFECTIOUS
DISEASE
“Definitely a key meeting
if you are involved with
Point-of-Care Diagnostics. Beyond the great networking,
the information learned from the talks, seminars, and
vendor discussions has been invaluable.”
CEO, axiVEND LLC
12:45 Refreshment Break in the Exhibit Hall – Last Chance for
Poster Viewing
1:30 Clinician vs. Lab: The Molecular Test Smackdown
Francesca Lee, MD, Associate Professor, Pathology and Internal Medicine
Technical Director, Clinical Microbiology and Preanalytical Services, UT
Southwestern Medical Center
Molecular testing, especially syndromic panel testing, has increased in
frequency of use for many patient types. While often beneficial, confusion
can arise due to the widespread availability of this testing combined with
limited frontline clinician education about significance. This presentation will
discuss scenarios in which syndromic panel testing can help or hurt patient
management, and present suggestions for how to optimize use.
INNOVATION IN POINT-OF-CARE AND
REMOTE TESTING
Matthew Binnicker, PhD, Consultant, Division of Clinical Microbiology, Vice Chair
of Supply Chain Management, Department of Laboratory Medicine and Pathology,
Vice Chair of Practice, Mayo Clinic; Chair, ASM’s Professional Development
Subcommittee
2:05 Advancing Innovation in Medical Devices
Suvajyoti Guha, PhD, Mechanical Engineer, Applied Mechanics, FDA CDRH
This talk will introduce a new program that has been created at the
FDA’s Center for Devices and Radiological Health (CDRH) for technology
preparedness and for assessing diagnostic and therapeutic medical devices
that use microfluidics. Because microfluidics-based devices may be different
from a functional standpoint than traditional macro-scale technologies,
the technological and regulatory considerations may be unique to this
emerging platform.
3:05 SARS-CoV-2 Testing: The University of Washington Experience
Alex Greninger, MD, PhD, MS, MPhil, Assistant Professor, Laboratory Medicine,
University of Washington
This talk will detail historical and current trends in SARS-CoV-2 testing at the
University of Washington Department of Laboratory Medicine and Pathology.
3:35 Innovations in At-Home Collection and Specimen Transport
Glen Hansen, PhD, Medical Director, Microbiology Molecular Diagnostics,
Hennepin County Medical Center
4:05 Close of Summit
CONTINUED
TABLE OF
CONTENTS
#NGDx22

CONFERENCE STREAMS
Liquid Biopsy and
POC and Infectious
Disease Stream
Companion Dx and
2022 COMPANION DX AND
REIMBURSEMENT CONFERENCES
AUGUST 22-23
Drug-Diagnostic Co-Development
and Companion Diagnostics
AGENDA
AUGUST 23-24
AGENDA
Companion Dx and
Diagnostics is a more-than-$60-billion industry with a critical role in
medicine, especially in today’s world of precision and personalized
medicine. Realizing this is an area that is ripe for disruption, the 2022
Companion Dx and Reimbursement stream will facilitate knowledge and
opinion exchange, discussion, and collaboration among pharmaceutical
and diagnostics executives, translational scientists, clinicians, business
experts, regulators, and both public and private payers. These programs
will spotlight the latest approaches, strategies, success stories that are
emerging in precision medicine.
TABLE OF
CONTENTS
#NGDx22

Drug-Diagnostic Co-Development and
Highlighting Innovation in Precision Medicine through Case Studies
COMPANION
DX AND
REIMBURSEMENT
Sunday, August 21
Monday, August 22
INNOVATIVE APPROACHES TO DRUG
DIAGNOSTICS IN ONCOLOGY
8:25 Chairperson Remarks
Neeraj Adya, PhD, Head, Diagnostics, Genmab
8:30 Barriers to Adoption of Liquid Biopsy in Precision Oncology
Jonathan Beer, Worldwide Precision Diagnostics Strategic Intelligence Lead,
Novartis Pharmaceuticals
Precision medicine therapies have demonstrated benefits for cancer patients
but are dependent on biomarker results to enable personalized treatment
selection. There are four key barriers to optimal precision oncology treatment:
Awareness, Availability, Adoption, and Access. Each of these hurdles will be
examined through the lens of how liquid biopsy tests in today’s healthcare
system are well suited to overcome some, but disadvantaged in other barriers.
9:00 Incorporating MRD as an Efficacy Endpoint in
Drug Development
Neeraj Adya, PhD, Head, Diagnostics, Genmab
Precision medicine is transforming treatment paradigms using complex
biomarkers in the interpretation of clinical data. Incorporating MRD status as a
biomarker in clinical trials can expedite clinical development by demonstrating
depth and durability of clinical response thus providing supportive evidence
of clinical benefit. The subsequent goal of establishing MRD as a surrogate
endpoint can enable faster access to therapies for patients. The current MRD
landscape and applications will be discussed.
9:30 Targeting Cancers with ecDNA Gene Amplification:
How to Overcome this Unique Challenge for Companion
Diagnostic Development
Peter M. Krein, PhD, Vice President, Precision Medicine, Boundless Bio, Inc.
ecDNA are large circles of DNA outside the cells’ chromosomes that can
be found in nearly half of all solid tumor cancers and are thought to be a
fundamental driver of cancer growth, resistance, and recurrence. Boundless
Bio’s approach to develop treatments specifically targeting cancers with
ecDNA gene amplification presents a unique challenge for companion
diagnostic development.
10:45 KEYNOTE PRESENTATION: The Clinical Utility
of Genetic Testing in Modern Cancer Care
Daryl Pritchard, PhD, Senior Vice President, Science Policy,
In the era of personalized medicine, payers, providers,
and guideline developers rely on their understanding of clinical utility
to assess the value of rapidly evolving genetic and genomic tests as
they develop policies and practices to provide access to them. In this
session, an updated definition of clinical utility will be presented that was
developed by an expert roundtable of personalized medicine leaders.
11:15 Improving the Accuracy, Reliability and Transparency
of NGS-Based Oncology Tests with Cancer Genomic Somatic
Reference Samples
Maryellen de Mars, PhD, SRS Technical Project Manager, Clinical Diagnostics,
Medical Device Innovation Consortium
The Somatic Reference Sample initiative is a public-private partnership
convened by MDIC guiding the development of reference samples used to
develop and validate NGS-based oncologic tests. A pilot project has been fully
funded by industry and philanthropic organizations to develop, manufacture,
and create validated data sets for an initial set of 10 reference samples.
Participating members of the SRS Initiative include FDA, NIH, diagnostics
manufacturers, funding organizations and payors.
1:15 Session Break
INSIGHTS INTO THE LATEST REGULATORY AND
POLICY UPDATES FOR COMPANION DIAGNOSTICS
Eunice Lee, PhD, Senior Director, Regulatory Affairs, Guardant Health
2:05 Global Trends in Diagnostic Regulation and the Impacts on Co-
Development Programs
Eunice Lee, PhD, Senior Director, Regulatory Affairs, Guardant Health
Precision medicine has been propelled by technological advances enabling the
development of novel treatments tailored to an individual patient. Companion
diagnostics (CDx) play a vital role in precision medicine, and there is a growing
number of regions with CDx policies. This presentation will provide an
overview of the evolving global regulatory landscape for diagnostics. Potential
strategies for navigating the changing environment with considerations for co-
development programs will also be discussed.
2:35 Drug-Diagnostic Co-Development in Rare Patient Populations:
Opportunities for Improving Patient Access to Clinical Trials
Mark Stewart, PhD, Vice President, Science Policy, Friends of Cancer Research
Facilitating the coordinated development and review of targeted therapies
and companion diagnostics for rare populations can be challenging. This
presentation will discuss opportunities to improve patient access to clinical
trials of biomarker-driven investigational products for rare diseases and expand
and expedite the development of companion diagnostic tests.
3:45 Liquid Biopsy Assays as Companion Diagnostics: A Review of
Regulatory Considerations, Current Utility and Future Direction
Jennifer S. Dickey, PhD, Vice President, Regulatory Quality, Personal Genome
Diagnostics, Inc.
The detection of circulating tumor DNA (ctDNA) has tremendous potential in
oncology to enable patient selection for therapy, monitor disease progression,
and improve timely access to new therapeutics. This presentation will review
regulatory considerations for liquid biopsy assays, explore the current utility
of liquid biopsy assays as companion diagnostics and as clinical trial assays,
and highlight future directions of the field including the detection of molecular
residual disease.
TABLE OF
CONTENTS
#NGDx22

COMPANION
DX AND
REIMBURSEMENT
CONTINUED
4:15 Panel Discussion: Should the CDx Regulatory Paradigm Evolve
to Keep Up with Technology?
Moderator: Lakshman Ramamurthy, PhD, Head Regulatory Affairs, Precision
Medicine Digital Health, GlaxoSmithKline
Panelists:
Katherine Donigan, PhD, Senior Director, Science and Regulatory, Biotechnology
Innovation Organization
4:45 How Europe’s in vitro Diagnostic Regulation is Impacting Global
Trials for Precision Medicine
Seamus Kearney, CEO Principal Consultant, ARC Regulatory Ltd.
As Europe’s long-awaited in vitro diagnostic regulation finally comes into force,
certain provisions reach beyond the EU to laboratories conducting biomarker
testing on EU patient samples. This talk will untangle the legislation and help
pharma and diagnostic sponsors understand what they must do and by when
to fully comply with the regulations.
with Poster Viewing
6:30 Close of Day
Tuesday, August 23
THE SCIENCE OF COMPANION DIAGNOSTICS
Timothy R. Schwartz, PhD, Medical Director, Biomarkers Diagnostics,
AstraZeneca
8:30 Utilizing Homologous Repair Status (HRD+/-) and Genetic
Signatures (TMB, LOH, MSI) as Companion Diagnostics in Clinical
Trials and/or Clinical Use
Timothy R. Schwartz, PhD, Medical Director, Biomarkers Diagnostics,
AstraZeneca
This talk will discuss the utility of novel biomarkers such as homologous repair
deficiency (HRD) genomic instability for personalizing therapy in patients with
cancer Assess the clinical rationale for tumor and HRD genomic instability
testing, as well as TMB, LOH, and MSI. Explore strategies to improve patient
engagement in shared decision-making regarding biomarker testing and
personalized treatment in cancer along the continuum of care.
9:00 Measuring Mitochondrial Priming for Predicting Response to
Cancer Therapy
Michael H. Cardone, PhD, Co-Founder, President CEO, Eutropics
Pharmaceuticals
Most cancer treatments work though activation of the cell suicide program of
apoptosis. Cells that more readily die in response to various stimuli are referred
to as “primed”. Our next generation predictive diagnostic tests directly measure
priming in a way that overcomes liabilities of the indirect measurements. The
new method (PRIMABTM) relies on proprietary complex specific antibodies and
is seen as simpler, more robust, and more amenable to clinical use.
9:30 A Blood-miRNA-Based Complementary Diagnostic Predicts
Immunotherapy Efficacy in Advanced Stage Lung Cancer with High
PD-L1 Expression
Bruno Steinkraus, PhD, CSO, Hummingbird Diagnostics GmbH
We describe the discovery, validation, and mechanistic insight into a blood-
based 5-microRNA risk (miRisk) score that predicts survival of non-small
cell lung cancer (NSCLC) patients receiving immunomonotherapy of either
pembrolizumab or nivolumab and performs better than the gold-standard of
PD-L1 (Rajakumar et al., 2022, npj Precision Oncology. In press.).
10:00 Development of Reference Material for DNA
Methylation Measurement
Zhiyong He, PhD, Biologist, NIST
NIST, in collaboration with the Early Detection Research Network (NCI, NIH)
is developing references materials for methylated genomic DNA. Methylated
DNA is promising biomarker for many cancer types. We utilized genomic DNA
from reference cell line to developed 5 different percentage of methylated
DNA as candidate methylated DNA reference materials and performed
interlaboratory studies.
•
•
Panelists:
TABLE OF
CONTENTS
#NGDx22

COMPANION
DX AND
REIMBURSEMENT
CONTINUED
•
•
e.g., HPV, STD)?
•
Panelists:
2:00 Close of Drug Diagnostic Co-Development and Companion
Diagnostic Conference
6:00 Close of Day
TABLE OF
CONTENTS
#NGDx22

Latest Developments in the Payment Landscape
COMPANION
DX AND
REIMBURSEMENT
Tuesday, August 23
•
•
Panelists:
•
•
e.g., HPV, STD)?
•
Panelists:
ACHIEVING REIMBURSEMENT SUCCESS IN THE
ERA OF PRECISION MEDICINE
Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates, LLC
2:20 Demystifying Molecular Diagnostics Coverage and
Reimbursement in Medicare
Gabriel Bien-Willner, MD, PhD, Medical Director, MolDx, Palmetto GBA
MolDX is a program operated by PalmettoGBA to set molecular diagnostics
policy and payor controls in 28 states. This talk will cover the scope and
philosophy of the program, as well as provide instruction to providers on how to
approach payors seeking coverage and reimbursement.
3:20 Cost Efficacy of Rapid Whole Genome Sequencing (rWGS) in
the Pediatric Intensive Care Unit
Erica F. Sanford Kobayashi, MD, Assistant Professor, Rady Children’s Hospital,
San Diego
Diagnostic and clinical utility of rWGS for critically ill children in the pediatric
ICU was examined. Retrospective cost data for children who received rWGS
found that the net cost was $54,554, representing $4,509 per QALY gained. This
quantitative, retrospective examination of healthcare utilization associated with
rWGS-informed medicine interventions revealed approximately one-third of a
QALY gained per patient tested at a cost per QALY approximately one-tenth of
that typically sought.
4:30 KEYNOTE PRESENTATION: Do Medicare
Legacy Policies Threaten Progress in Precision
Medicine?
Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates, LLC
In 2013, as modern precision medicine was taking off, CMS
began bundling lab tests in the hospital outpatient setting, except genetic
tests. In 2022, this policy becomes increasingly impractical as advances
in areas like proteomics and AI move into pathology applications.
Pathology and proteomic testing are usually “bundled” into the cost of the
tissue biopsy or office visit. With separate payment for genomics, CMS
potentially discourages other fields of innovation.
5:00 Panel Discussion: The Evolution of Medical Policy and Coverage
Requirements in Genomic Testing
Moderator: Mark Hiatt, MD, MBA, MS, Vice President, Guardant Health
As technology surges, and a virus changes the world, what has changed, and
what has remained the same, with respect to what it takes for a diagnostic
technology to be endorsed in medical policy and paid for by a health plan? This
panel of experts will opine from their rich experiences as payers in the public
and private sectors, for both national and regional plans.
Panelists:
Rahul Singal, MD, CMO, Avalon Healthcare Solutions
Gabriel Bien-Willner, MD, PhD, Medical Director, MolDx, Palmetto GBA
TABLE OF
CONTENTS
#NGDx22

Latest Developments in the Payment Landscape
COMPANION
DX AND
REIMBURSEMENT
CONTINUED
6:00 Close of Day
TRENDS IN COVERAGE AND REIMBURSEMENT
AND COVID LESSONS LEARNED
Gillian Hooker, PhD, CSO, Concert Genetics
8:30 Panel Discussion: The Impact of the COVID-19 Pandemic on
Laboratory Reimbursement Trends
Moderator: John F. Warren, Owner, Gettysburg Healthcare Consultants
The COVID-19 pandemic has brought unprecedented changes to our lives
and to the way we do business. Join our panel of industry and government
experts as they discuss how their day-to-day operations and their strategic
business planning have changed. Learn how payers and laboratories alike have
had to adjust to the new normal and how you can learn from their experience.
Panelists:
Deborah R. Godes, Vice President, McDermott+Consulting LLC
Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott
Laboratories
Brooks Gordon, Director, Corporate Partnerships, GENETWORx
9:30 Trends in the Genetic Testing Landscape: Offerings,
Utilization Coverage
Gillian Hooker, PhD, CSO, Concert Genetics
This talk will review trends across the genetic testing landscape. Drawing on a
consistently maintained database of tests marketed in the U.S., growth in the
number and type of genetic tests in the market will be reviewed. Additionally,
data from a nationwide claims data set of genetic testing claims will be
presented to support a discussion of trends in utilization and coverage of
genetic tests among the commercially insured population.
10:45 Panel Discussion: Paying for Innovation: Emerging Trends in
Value-Based Care
Moderator: Megan Anderson Brooks, PhD, Principal, Innovation Policy Solutions
LLC
Anticipation of a new transitional coverage for emerging technologies (TCET)
rule this fall, efforts to expand statutory coverage of new categories for
multi-cancer screenings, and Medicare’s proposals for new care models,
opportunities abound to better align coverage policies with the current
state of the science. This panel focuses on what to expect from the Biden
Administration and Congress, how to identify opportunities for your business,
and strategies to engage.
11:45 Luncheon Presentation (Sponsorship Opportunity Available) or
Enjoy Lunch on Your Own
12:45 pm Refreshment Break in the Exhibit Hall – Last Chance for
Poster Viewing
COVERAGE AND REIMBURSEMENT AS A
STRATEGIC PRIORITY
Mark Hiatt, MD, MBA, MS, Vice President, Guardant Health
1:35 CO-PRESENTATION: The Role of Alternative Payers in the
Commercialization of a Novel Diagnostic
Hannah Mamuszka, Co-Founder CEO, Alva10
Lena Chaihorsky, Co-Founder Vice President, Payer Innovation, Alva10
Convincing traditional health insurers of the medical necessity of novel
diagnostics can be a difficult and complex endeavor. Through case study
examples, this talk will explore a series of scenarios where other payers
with alternative economic incentives (such as pharmacy benefit managers,
employers, unions, and benefit groups) are implementing innovative strategies
to adopt diagnostics and enable the commercialization and/or utilization
of diagnostics.
2:05 NGS Testing in aNSCLC: A Retrospective Analysis Using Real-
World Data (RWD) to Measure Testing Turnaround Time and Its
Impact on Patient Results and Coverage
Robert H. Dumanois, Director, Reimbursement Strategy, Thermo Fisher Scientific
This presentation will elaborate on the 2018-2020 NGS testing and coverage
experiences specific to the diagnosis and treatment for stage IV, non-small cell
lung cancer patients, utilizing real-world data from ~1,000 U.S. oncologists.
Addressed topics will include how NGS testing impacts first-line therapy
decisions at the beginning of treatment (before biomarker results are available),
coverage considerations, and the overall impact on patient outcomes.
3:05 Reimagining Healthcare to Make it More Integrated and
Affordable for High Claimants
Mark Hiatt, MD, MBA, MS, Vice President, Guardant Health
TABLE OF
CONTENTS
#NGDx22

CONFERENCE STREAMS
POC and Infectious
Disease Stream
Companion Dx and
2022 LIQUID BIOPSY AND EARLY
DETECTION CONFERENCES
AUGUST 22-23
Liquid Biopsy for Disease
Management
AGENDA
AUGUST 23-24
AGENDA
Liquid Biopsy and
Liquid Biopsy and
The Liquid Biopsy and Early Detection stream focuses on the latest
approaches, strategies, success stories and case studies of liquid
biopsy and companion diagnostics that are emerging for oncology
and precision medicine. The Liquid Biopsy for Disease Management
track is followed by the Early Cancer Surveillance track. The stream
will feature technologies, biomarkers, clinical results, and translational
strategies to enable advanced platforms to better diagnose, prognose,
and treat cancer.
TABLE OF
CONTENTS
#NGDx22

Liquid Biopsy for Disease Management
From Discovery to Clinical Use
LIQUID BIOPSY
AND EARLY
DETECTION
Sunday, August 21
Monday, August 22
TECHNOLOGIES FOR ISOLATION AND
ANALYSIS OF LIQUID BIOPSY MARKERS: CTCs,
ctDNA and EVs
Steven A. Soper, PhD, Professor Director, CBM2 Precision Medicine, Chemistry
Mechanical Engineering, University of Kansas, Lawrence
8:30 Extracellular Vesicle-Based Disease Diagnostics on a
Microchip: Finding Nanoscale Needles in a Nanoscale Haystack
David Issadore, PhD, Assistant Professor, Bioengineering Electrical Systems
Engineering, University of Pennsylvania
I will focus on our recent work on ‘digital assays.’ Digital assays – in which ultra-
sensitive molecular measurements are made by performing millions of parallel
experiments in picoliter droplets – have generated enormous enthusiasm due
to their single molecule resolution. We are developing a hybrid microelectronic/
microfluidic chip to ‘unlock’ droplet-based assays for clinical use.
9:00 Mechano-Node Pore Sensing for Disease Monitoring
Lydia Sohn, PhD, Chancellor’s Professor, Mechanical Engineering, University of
California, Berkeley
All-trans retinoic acid (ATRA) is an essential therapy in treating acute pro-
myelocytic leukemia (APL); however, nearly 20% of APL patients are resistant to
ATRA. Currently, there are no biomarkers for ATRA resistance. Using mechano-
node-pore sensing (mechano-NPS), an electronic method to mechanically
phenotype cells, we have shown that ATRA-resistive APL cells are more stiff
than ATRA-responsive cells. I will discuss how mechano-NPS could thus
potentially be used to monitor APL resistance.
9:30 Using Neuronal-Enriched Extracellular Vesicles as Biomarkers
for Neurocognitive Decline
Lynn Pulliam, PhD, Professor, Departments of Laboratory Medicine and Medicine,
University of California, San Francisco
Our lab is interested in isolating neuronal-enriched extracellular vesicles
(nEV) from plasma to determine the state of the neuron in real time. We have
characterized nEVs using several techniques and interrogated the cargo from
people with Alzheimer’s disease, HIV and COVID with the aim of determining
plasma biomarkers for neurocognitive decline.
10:45 Nanoplasmonic Sensing Technologies for Circulating Tumor-
Derived Extracellular Vesicle Analysis
Hyungsoon Im, PhD, Assistant Professor, Center for Systems Biology,
Massachusetts General Hospital, Harvard Medical School
Tumor-derived extracellular vesicles (EVs) have gained much interest as
circulating biomarkers for cancer diagnosis and treatment monitoring. We
have developed various nanoplasmonic sensing (nPLEX) technologies for
the sensitive and robust detection of tumor-derived EVs directly from clinical
samples. In this presentation, I will discuss the nPLEX sensing technologies
and their applications for cancer diagnosis, and their future directions for
clinical translation.
ACTIONABLE ALTERATIONS IN cfDNA and
CTCs FOR EARLY CANCER DETECTION AND
PRECISION MEDICINE
11:15 Integrating CTC Biology for the Development of Novel
Therapeutics to Eradicate Cancer Metastases
Pritesh J. Gandhi, PharmD, CEO, TellBio, Inc.
TellBio is an oncology company revolutionizing the detection and treatment
of cancer through its unique and proprietary circulating tumor cells (CTCs)
technology, TellDx, and complementary therapeutic platform, TellRx. The TellDx
CTC system is a diagnostic solution to detect and isolate live CTCs from liquid
biopsies. The microfluidic system has agile features and can operate in a
negative depletion or positive selection mode to enrich CTCs.
1:15 Session Break
Stuart S. Martin, PhD, Professor, Physiology, Marlene and Stewart Greenebaum
NCI Comprehensive Cancer Center, University of Maryland School of Medicine
1:35 The mDETECT Assay for Triple Negative Breast Cancer (TNBC)
Offers Sensitive and Quantitative Detection of Metastatic Disease
Christopher Mueller, PhD, Professor of Biomedical and Molecular Sciences,
Queen’s University School of Medicine
Our second-generation mDETECT liquid biopsy for Triple Negative Breast
Cancer is based on the detection of DNA methylation using a targeted next-
generation sequencing approach. In an independent validation, cohort is
achieved and AUC of 0.97 with a sensitivity of 93% for specificity of 100%, using
2 mls of serum. It has the potential to quantitatively monitor tumour burden in
this aggressive subtype of breast cancer.
2:05 Assessing Precision Medicine and Immuno-Oncology
Biomarkers by Circulating Tumor Cell Liquid Biopsy
Andi Cani, PhD, Postdoc, Daniel F. Hayes Group, Division of Hematology and
Oncology, Rogel Cancer Center; Department of Internal Medicine, Michigan
Medicine, University of Michigan Medical School
The success of precision and immuno-oncology rests on approved genomic
biomarkers such as mutations, copy number alterations, tumor mutation
burden, and microsatellite instability. While their assessment in ctDNA has been
developed, their measurement can be limited by low ctDNA tumor fraction.
CTC single-cell NGS is rather unexplored for complementing tissue and ctDNA
biomarker detection. We show feasibility and validity of this approach which
suggests further exploration of its clinical utility.
2:35 Clinical Validation of a Targeted Methylation-Based Multi-
Cancer Early Detection Test Using an Independent Validation Set
Minetta C. Liu, MD, Professor Research Chair, Oncology Consultant, Lab
Medicine Pathology, Mayo Clinic Foundation
A multi-cancer early detection (MCED) test used to complement existing
screening could increase the number of cancers detected through population
screening, potentially improving clinical outcomes.
TABLE OF
CONTENTS
#NGDx22

LIQUID BIOPSY
AND EARLY
DETECTION
CONTINUED
3:45 Technical Validation Considerations in Clinical ctDNA Tests
Christina Lockwood, PhD, DABCC, DABMGG, Associate Professor, Laboratory
Medicine; Director, Genetics Solid Tumors Laboratory; Medical Director,
Brotman Baty Institute for Precision Medicine, University of Washington
I will discuss analytical validation challenges and opportunities in clinical
circulating tumor DNA testing. Analyses from the AMP liquid biopsy working
group have identified opportunities for validation standardization, which will
facilitate additional clinical implementation.
4:15 Methylation of cfDNA as an Indicator of Cancer and
Metastasis Location
Megan Barefoot, Doctoral Student, Georgetown University School of Medicine
Cell-free DNA fragments released into the circulation from dying cells can
be traced back to the tissues and cell types they originated from using DNA
methylation, an epigenetic regulatory mechanism that is highly cell-type
specific. Decoding changes in the cellular origins of cfDNA over time can reveal
altered host tissue homeostasis due to local cancer invasion and metastatic
spread to distant organs as well as treatment responses.
with Poster Viewing
6:30 Close of Day
Tuesday, August 23
Bringing Liquid Biopsy into Early Cancer Detection
Lynn Sorbara, PhD, Program Director, Cancer Biomarkers Research Group,
National Cancer Institute (NCI), NIH
•
What are the greatest impediments to bringing liquid biopsy technologies into
the early cancer detection space?
•
How can we overcome the low levels of target analytes, low limit of
detection, etc.?
•
What can be done to improve specificity, sensitivity, and precision?
•
Is artificial intelligence/machine learning the next step to validation?
•
Is liquid biopsy cost-effective in the early cancer space?
TAILORING IMMUNO-ONCOLOGY WITH
LIQUID BIOPSY
Catherine Alix-Panabières, PhD, Associate Professor and Director, Laboratory of
Rare Human Circulating Cells (LCCRH), University Medical Center of Montpellier,
France
8:30 KEYNOTE PRESENTATION: Liquid Biopsy
Approaches to Predict Response or Resistance to
Immune Checkpoint Inhibition Therapy in Patients
with Solid Tumors
Klaus Pantel, PhD, Professor, Medicine Director
Chairman, Institute of Tumor Biology, University Hospital
Hamburg, Eppendorf
Clinical applications of liquid biopsy analyses include early cancer
detection, improved cancer staging, early detection of relapse, real-
time monitoring of therapeutic efficacy and detection of therapeutic
targets and resistance mechanisms. In particular, the detection and
characterization of circulating tumor cells (CTCs) and cell-free tumor DNA
(ctDNA) have received great attention as “liquid biopsy” biomarkers in
clinical trials on immune checkpoint inhibition therapy to predict response
or resistance.
9:00 Metastasis-Initiator Circulating Tumor Cells: One of the Keys to
Understand the Biology of the Metastatic Cascade
Catherine Alix-Panabières, PhD, Associate Professor and Director, Laboratory of
Rare Human Circulating Cells (LCCRH), University Medical Center of Montpellier,
France
The development of blood-based, tumor specific biomarkers called real-time
liquid biopsy such as circulating tumor cells (CTCs) have made significant
advances over the last years in cancer research. In my lecture, I will present
the hallmarks of the first and still only nine permanent colon CTC lines from
peripheral blood samples of a patient with metastatic colon cancer collected at
different time points during treatment and cancer progression.
9:30 Circulating Exosomes as a Liquid Biopsy Approach for Precision
Cancer Therapy
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
The field of liquid biopsy for cancer screening has expanded considerably in the
recent past, with applications ranging from single cancer screening to multi-
cancer screening. The current state of the field and the different performance
requirements for single cancer vs. multi-cancer will be presented using lung
cancer screening as a single cancer focus and as part of a multi-cancer screen
as a case in point.
TABLE OF
CONTENTS
#NGDx22

LIQUID BIOPSY
AND EARLY
DETECTION
CONTINUED
•
•
Panelists:
•
•
e.g., HPV, STD)?
•
Panelists:
2:00 Close of Liquid Biopsy for Disease Management Conference
TABLE OF
CONTENTS
#NGDx22

CHI’S INAUGURAL | AUGUST 23-24, 2022
The Opportunities and Challenges
LIQUID BIOPSY
AND EARLY
DETECTION
Tuesday, August 23
•
•
Panelists:
•
•
e.g., HPV, STD)?
•
Panelists:
2:00 Close of Liquid Biopsy for Disease Management Conference
OVERVIEW: EARLY CANCER SURVEILLANCE
Robert Smith, PhD, Senior Vice President, Cancer Screening, American Cancer
Society, Inc.
2:20 Multi-Cancer Early Detection Testing: Hopes,
Hypes and Progress
Sudhir Srivastava, PhD, Chief, Cancer Biomarkers Research Group, NIH NCI
Liquid biopsy (LB) is gaining momentum in its application for the early detection
of cancer because it is noninvasive, can detect multiple cancers, and is likely
to be acceptable in clinical practice either as an adjunct or a stand-alone test
in combination with the standard of care. The opportunities for such testing
to change the paradigm for cancer screening will be presented, along with
challenges that need to be addressed.
2:50 Global and Local Implications of Early Cancer Detection with
Multi-Cancer Technologies
Danny A. Milner, Jr., MD, MSc, MBA, FASCP
Multi-cancer early detection has implications that vary by geography and
tool performance. In high-income countries, MCED could lead to disruptive
innovation, creative destruction, and massive downstaging for cancer patients.
In low-income countries, MCED could also lead to changes with enormous
impact on morbidity and mortality, but less disruption. Why there is such
a difference, the barriers that exist for both, and an ethical way forward
will be discussed.
3:20 Measuring the Efficacy and Effectiveness of Multi-Cancer Early
Detection Tests: Are We Up for the Challenge?
Robert Smith, PhD, Senior Vice President, Cancer Screening, American Cancer
Society, Inc.
As advances in new cancer screening accelerates, early cancer detection may
become more feasible and accessible, and include a much broader group of
cancers. These technologies must be evaluated in the population to ensure
their efficacy and favorable balance of benefits to harms. To avoid stifling
innovation we must embrace the challenge to develop new approaches to
evaluation, including trustworthy new endpoints.
4:30 CO-PRESENTATION: RNA: The Next-Generation of Stool-
Based CRC Screening
Vince Wong, JD, MBA, Chief Commercial Officer, Geneoscopy, Inc.
Haytham Gareer, MD, PhD, MBA, CMO, Medical and Scientific Affairs,
Geneoscopy, Inc.
Geneoscopy developed a method to reliably extract and evaluate stool-derived
eukaryotic RNA (seRNA) biomarkers, overcoming challenges in extensive
RNA degradation and high bacterial transcript burden. Using this technology,
Geneoscopy developed a multi-factor RNA stool test to detect colorectal
neoplasia in average-risk individuals, demonstrating ~40% improved detection
over existing non-invasive screening tests. Preliminary data has been shown
the platform’s feasibility for improved monitoring, diagnosis, and treatment of
other GI diseases.
TABLE OF
CONTENTS
#NGDx22

CONTINUED
CHI’S INAUGURAL | AUGUST 23-24, 2022
The Opportunities and Challenges
LIQUID BIOPSY
AND EARLY
DETECTION
5:00 Early Detection Redefined through a Novel Bio Platform:
Detecting Lung Cancer, Breast Cancer and NAFLD at Their
Earliest Stages
Elizabeth Cormier-May, COO, IV Bioholding
5:30 Pancreatic Cancer Detection in New-Onset Diabetes Patients
Using Epigenetic Signatures in Cell-Free DNA
Sam Levy, PhD, CSO, Bluestar Genomics
Pancreatic cancer has poor survival rates, largely driven by late diagnosis. Our
epigenetics technology platform, which measures DNA hydroxymethylation,
delivers the first-of-its-kind cancer detection test. With a robust performance
further validated in an independent cohort with high sensitivity and specificity,
our pancreatic cancer test is specifically designed to improve patient outcomes
by enabling early detection of occult pancreatic cancer in high-risk populations
such as patients with new-onset diabetes.
NOVEL EARLY DETECTION BIOMARKERS
Danny A. Milner, Jr., MD, MSc, MBA, FASCP
8:30 Metabolic Profiling by NMR Gives Powerful Insight for
Cancer Diagnosis
James Larkin, PhD, Department of Oncology, University of Oxford (UK), and
Founder CEO, Oxomics
The diagnosis of cancer in patients with nonspecific symptoms is a major
clinical challenge leading to poorer prognoses as patients are diagnosed late.
Here we show that biofluid metabolomics using nuclear magnetic resonance
(NMR) can identify cancer in a cohort of 300 at-risk patients with high
sensitivity and specificity, before considering the larger possibilities for biofluid
metabolomics in the diagnosis and management of cancer.
9:00 Metabolism as an Information Layer for Multi-Cancer Early
Detection: The Role of GAGomes
Francesco Gatto, PhD, CSO and Co-Founder, Elypta AB
Liquid biopsies based on genomic biomarkers could make multi-cancer early
detection (MCED) realistic, but limitations include ~10% stage I sensitivity; the
inability to detect specific types like gliomas; complex assays; and potential
over-diagnosis. The potential of metabolism for MCED will be illustrated. Our
studies indicate that plasma and urine glycosaminoglycan profiles (GAGomes)
doubled stage I sensitivity and preferentially detected poor prognosis any-type
cancer with a simple IVD-ready assay.
9:30 Microbiome Driven Liquid Biopsy to Enhance Early-Stage
Cancer Detection
Sandrine Miller-Montgomery, PharmD, PhD, President and CEO, Micronoma, Inc.
Microbiome entered in 2022 the Hallmarks of Cancer. Yet, mostly gut
microbiome is considered at this stage. In our presentation, we will discuss the
importance of newly discovered tissue and circulating microbiomes in early
cancer detection as well as MRD or relapse monitoring. We will also cover the
potential to greatly improve treatment or drug clinical trials with this new set of
microbial biomarkers easily accessible in blood.
10:45 Early Cancer Detection Using Exomes as the Source for
Cancer Biomarkers
Antonio Chiesi, PhD, Founder CEO, Exosomics Siena SpA
11:45 Luncheon Presentation (Sponsorship Opportunity Available) or
Enjoy Lunch on Your Own
12:45 pm Refreshment Break in the Exhibit Hall – Last Chance for
Poster Viewing
EARLY DETECTION OF MULTIPLE CANCERS
USING DNA
Sudhir Srivastava, PhD, Chief, Cancer Biomarkers Research Group, NIH NCI
1:35 cfDNA Fragmentation Assays for the Early Detection of Cancer
Nicholas C. Dracopoli, PhD, CSO, Delfi Diagnostics
Cell-free DNA (cfDNA) consists of small nucleic acid fragments entering the
bloodstream during apoptosis or necrosis. cfDNA fragmentation patterns
detected by low-coverage whole-genome sequencing can be used to detect the
presence of circulating tumor DNA (ctDNA) in a background of cfDNA mostly
derived from hematologic cells. This presentation will describe the development
of a blood-based, whole-genome, next-generation sequencing (NGS) test to
detect early stages of cancer.
Stephen Hahn, MD, CEO, Harbinger Health
2:35 Addressing the Cancer Epidemic with Multi-Cancer Early
Detection (MCED)
Megan P. Hall, PhD, Vice President Medical Affairs, GRAIL LLC
A methylation-based MCED detects a common cancer signal across many
cancer types, generates a low false positive rate, and predicts the cancer
origin to direct downstream diagnostics. The performance of this MCED, the
underlying biology of the signal that results in a balance of detecting more
aggressive cancers while minimizing the risk of overdiagnosis, and the potential
impact of implementing MCEDs in conjunction with standard-of-care cancer
screening will be discussed.
Craig Eagle, MD, CMO, Guardant Health
Hatim Allawi, MD, Senior Vice President, Research Technology Development,
Exact Sciences Corp.
TABLE OF
CONTENTS
#NGDx22

LIVE IN-PERSON OR
VIRTUAL REAL-TIME
PRESENT A POSTER
and SAVE $50!*
Reasons you should present your research poster at this conference:
• Your research will be seen by our international delegation, representing leaders
from top pharmaceutical, biotech, academic and government institutions
• Discuss your research and collaborate with other attendees
• Your poster presentation will be published in our conference materials
• Receive $50 off your registration*
Register and indicate that you
would like to present a poster. Once
your registration has been fully
processed, we will send an email
with a unique link and instructions
for submitting your abstract and
other materials.
*this discount does not apply to product or service providers
SUMMIT
Cambridge Healthtech Institute encourages attendees to gain further
exposure by presenting their work in the poster sessions. To secure
an onsite poster board and/or ensure your virtual poster presentation
is included in the conference materials, your full submission must be
received, and your registration paid in full by July 15, 2022.
LEARN MORE
MEDIA PARTNERS
Sponsoring Organizations
Lead Sponsoring Publications
DiagnosticsWorld
Lead Media Partners
TM
Sponsoring Publications
CLINICAL
RESEARCH
NEWS
Web Partners
TABLE OF
CONTENTS
#NGDx22

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TABLE OF
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#NGDx22

SUMMIT
AUGUST 22-24, 2022
WASHINGTON, D.C.
IN-PERSON VIRTUAL
VIRTUAL REAL-TIME OPTIONS
Includes access to virtual conferences
and event features including poster
presentations, interactive breakout groups,
facilitated networking, on-demand access
and more!
learn more
POST-EVENT
ON-DEMAND ONLY
Includes post-event recorded
access to ALL conferences.
Does not include access to
live QA or networking.
learn more
FOR ADDITIONAL REGISTRATION OPTIONS, VISIT OUR EVENT WEBSITE
GROUP DISCOUNTS
Have your colleagues or entire team attend!
Purchase a full price registration and
participants from the same organization
will receive a 35% discount when registering
through the Group Registration page.
learn more
Go to our online Registration Page for
quick and easy Registration. Want to Register by Phone? Contact our Registration Department
at 781-972-5400 or Toll-free in the US at 888-999-6288.
Please use
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INDIVIDUAL CONFERENCE PRICING
Academic, Government,
PREMIUM PACKAGE BEST VALUE! Commercial Hospital-affiliated
(Includes in-person or virtual access to ALL conferences and networking events. In addition,
you will have on-demand access for one year.
PLUS! Save 10% off your Short Course registration.)
Early Registration Rates until May 20 $2,699 $1,299
Advance Registration Rates until July 15 $2,899 $1,399
Standard Pricing After July 15 $3,099 $1,499
BASIC PACKAGE
(Includes in-person or virtual access to ONE conference (1.5 days) networking events. Plus, On-Demand access.)
Early Registration Rates until May 20 $1,799 $749
Advance Registration Rates until July 15 $1,949 $899
Standard Pricing After July 15 $2,149 $949
INDIVIDUAL SHORT COURSE PRICING
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(Short courses will be held in-person only.) Commercial Hospital-affiliated
1 Short Course $599 $399
Please refer to Short Course list on page 6
Pricing and Registration Information POSTER SUBMISSION: Poster
materials are due by July 15, 2022.
Once your registration has been fully
processed, we will send an email
containing a unique link allowing you
to submit your poster abstract and
other materials. If you do not receive
your link within 5 business days,
please contact
jring@healthtech.com.
* this discount does not apply to
product or service providers
CHI reserves the right to publish your
poster title and abstract in various
marketing materials and products.
Group Discounts are Available!
Special rates are available for
multiple attendees from the same
organization. For more information
on group discounts contact
Uma Patel, 781-972-5447
upatel@healthtech.com
Alumni Discount - SAVE 20%
CHI appreciates your participation
at its events. As a result of the great
loyalty you have shown us, we are
pleased to extend to you the exclusive
opportunity to save an additional 20%
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*Alumni, Twitter, LinkedIN, Facebook
or any other promotional discounts
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POSTER DISCOUNT:
$50 OFF*
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DISCOUNTS
TABLE OF
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#NGDx22

CHI's Next Generation Dx Summit 2022 | August 22-24, 2022 | Washington, D.C.

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