With NGS assays moving into clinical use and new technologies being developed for a host of infectious diseases, it is more important than ever to keep on top of the latest advances in the field. Cambridge Healthtech Institute’s 4th Annual Molecular Diagnostics for Infectious Disease symposium will discuss in detail the process of moving sequencing into clinical use with an examination of reference vs. clinical labs, metagenomics vs. panel-based tests, investments in bioinformatics and physician education. We will also examine rapid susceptibility testing in the light of the new breakpoints, how they are used and the role genotypic vs. phenotypic testing. Special attention will also be paid to new technologies for host response and clinical applications of microbiome analysis. We will also have a discussion centered around the regulatory landscape for NGS diagnostics and what to expect as we will look into the future of molecular diagnostics for infectious disease.

Final Agenda

Thursday, March 14

7:00 am Registration Open and Morning Coffee (Continental Foyer)

MOLECULAR DIAGNOSTICS FOR PUBLIC HEALTH: INFECTIOUS DISEASE SURVEILLANCE AND RESPONSE
Continental 6

8:55 Chairperson’s Opening Remarks

Duncan MacCannell, PhD, CSO, Office of Advanced Molecular Detection, Centers for Disease Control and Prevention

9:00 NEW: Advanced Molecular Detection in Public Health

MacCannell_DuncanDuncan MacCannell, PhD, CSO, Office of Advanced Molecular Detection, Centers for Disease Control and Prevention

This presentation will examine the impact of advanced laboratory and scientific computing technologies on infectious disease surveillance and outbreak response, and the impact that CDC’s Advanced Molecular Detection program has had in catalyzing innovation and change.

CLINICAL METAGENOMICS: THE HOPE, THE HYPE, AND THE HERE AND NOW

9:45 NEW: Diagnostic Metagenomic Testing – From Research to Clinical Care

Chiu_CharlesCharles 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 game-changing technology for infectious disease diagnosis as nearly all pathogens – viruses, bacteria, fungi, and parasites – can be detected in a single assay. I will discuss challenges in development and validation of an mNGS-based assay in a CLIA laboratory regulatory environment, and steps we took to overcome them. I will also review the results of the PDAID (Precision Diagnosis of Acute Infectious Diseases) study, a 1-year, multi-hospital prospective cohort study evaluating the clinical utility and cost-effectiveness of a clinical mNGS assay for diagnosis of meningitis and encephalitis. I will discuss current efforts to expand clinical mNGS validation to all body fluids, as well as new transformative diagnostic technologies on the horizon, including machine learning-based RNA-Seq and nanopore sequencing.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

CLINICAL METAGENOMICS: THE HOPE, THE HYPE, AND THE HERE AND NOW (CONT.)
Continental 6

11:15 FEATURED DISCUSSION: The Hope and Hype of Clinical Metagenomics

Alex GreningerAlex Greninger, MD, PhD, Assistant Professor, Laboratory Medicine, Assistant Director, Clinical Virology Laboratory, University of Washington School of Medicine


Charles ChiuCharles 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


This point-counterpoint discussion will discuss the status of infectious disease diagnostics and the clinical applications and utility of metagenomics approaches. The speakers will address questions about what kind of metagenomic assays will get adopted first, who will be running these assays, barriers to implementation, regulatory issues from the CLIA and FDA perspectives, differences between traditional diagnostic microbiology and metagenomics, differences in research and clinical labs, parallels between metagenomic NGS and cancer/NIPT NGS, and the role of industry in advancing the field.

12:15 pm An Introduction to Cyclic Olefin Polymer for the Use in Life Science Applications

Atupem_LarryLarry Atupem, Senior Business Development Specialist, Zeon

The unique inherent properties ZEONEX® and ZEONOR® Cyclo Olefin Polymer (COP) allow engineers to expand their device and detection capabilities when constructing a fully integrated consumable versus using more traditional polymers.

12:30 Session Break

12:40 Luncheon Presentation: Infectious Disease Identification using Cell-free DNA Sequencing

Blauwkamp_TimothyTimothy Blauwkamp, PhD, CSO, Karius, Inc.

Thousands of pathogens can infect humans, but only a fraction are readily identifiable with existing diagnostic methods. Karius uses microbial cell-free DNA sequencing to detect bacteria, fungi, DNA viruses, or eukaryotic pathogens causing disease throughout the body.

1:15 Session Break

NEW TECHNOLOGIES FOR HOST RESPONSE
Continental 6

1:55 Chairperson’s Remarks

Timothy E. Sweeney, MD, PhD, CEO, Inflammatix

2:00 Recent Clearances of Host Biomarker Assays and Comparator Methods

Roth_KrisKristian Roth, PhD, Supervisory Chemist, Office of in vitro Diagnostics Division of Microbiology, US Food and Drug Administration

Host biomarker assays are novel diagnostics that have the potential to become an increasingly informative method for improving patient care. Recent clearances will be discussed along with challenges encountered when developing appropriate comparator methods. Limitations of validation study designs and additional approaches by which the FDA has determined novel biomarkers to be safe and effective for the diagnosis of infectious diseases will be presented.

2:30 Pioneering Host Response Diagnostics for Infectious and Inflammatory Diseases

Tsalik_EphraimEphraim L. Tsalik, MD, MHS, PhD, Associate Professor, Medicine, Duke University School of Medicine; Founder, Predigen, Inc.

For more than a decade, Duke, and now Predigen, have been at the forefront of capturing the molecular response to exogenous perturbations to develop diagnostic and predictive signatures for disease. Infectious disease pathogens induce robust and specific host responses that can be assayed using RNA and proteomic technologies. Using machine learning and advanced analytics, we have pioneered the discovery of highly specific signatures and have translated them into clinically relevant assays. Our strategy is to develop rapid diagnostic tests for use in hospital, clinic, and home.

MeMedDiagnostics 3:00 NEW: A Host-Protein Signature (MeMed BV™) and Pioneering Point-of-Care Platform (MeMed Key™) for Accurately Distinguishing between Bacterial and Viral Infections in 15 Minutes.

Eden EranEran Eden, PhD, CEO, MeMed Diagnostics Ltd
For nearly a decade, with collaborators around the globe, MeMed has developed an innovative host-protein signature called MeMed BV™ for accurately distinguishing between bacterial and viral infections. The signature includes measurements of circulating blood host-proteins integrated using machine learning algorithms. The signature was rigorously validated in external, double-blind prospective clinical studies, and applied in real world setting on >10,000 patients. MeMed Key™  is a first of its kind immunoassay platform that opens the way to measuring multiple proteins with central lab performance at the point-of-care. Key™ will run the MeMed BV™ test within 15 minutes. A pipeline of additional innovative host-response assays that address a wide range of disorders, including neonatal fever and sepsis, are underway.

3:30 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall

4:15 Robust Host-Response Diagnostics at the Point of Care: HostDx Assays for Infections and Sepsis

Sweeney_TimTimothy E. Sweeney, MD, PhD, CEO, Inflammatix

Diagnostics for acute infections and sepsis typically focus on ‘finding the bug,’ but most patients with infections never have pathogens in their bloodstream. HostDx™ assays use robust patterns of mRNA biomarkers from whole blood to determine the presence, type, and severity of any acute bacterial or viral infection. Multiple prospective studies have confirmed accuracy across varied populations. Inflammatix is developing the assays into POC assays with <30-minute turnaround time, and is expanding its portfolio of HostDx tests with its proprietary bioinformatics pipeline.

4:45 Closing the Gap in Sepsis Diagnosis

Alavie_TinoTino Alavie, PhD, CEO, Qvella Corporation

Sepsis, its severity, and how to manage affected patients is confounding as symptoms are common to many other conditions. The problem is further exacerbated when faced with treatment options in the absence of timely diagnostic information. This presentation highlights efforts of the broader community in closing the gap in sepsis diagnosis with an emphasis on Qvella’s take on the opportunity and challenges.

ANTIMICROBIAL SUSCEPTIBILITY TESTING AND ANTIBIOTIC STEWARDSHIP
Continental 6

5:15 What’s in a Name? When Taxonomy and Susceptibility Testing Collide

She_RosemaryRosemary She, MD, Associate Professor, Clinical Pathology, Keck School of Medicine, University of Southern California

While taxonomists are busy uncovering bacterial diversity and reorganizing the tree of life, the clinical laboratory must grapple with their ramifications for patient care testing. This presentation will discuss the challenges that laboratories face in balancing use of accurate nomenclature versus use of meaningful organism names; how modern taxonomy affects longstanding paradigms in susceptibility testing; and how understanding microorganism diversity can be used to improve patient care.

5:45 Reception in the Exhibit Hall with Poster Viewing

6:45 Close of Day

Friday, March 15

8:00 am Registration Open and Morning Coffee (Continental Foyer)

ANTIMICROBIAL SUSCEPTIBILITY TESTING AND ANTIBIOTIC STEWARDSHIP (CONT.)
Continental 6

8:25 Chairperson’s Remarks

Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and Medical Director, Medical College of Wisconsin

8:30 The Value of AST and Challenges to Targeted Antibiotic Therapy in Acute Care Settings

May_LarissaLarissa May, MD, MSPH, MSHS, Professor, Emergency Medicine; Director, Emergency Department Antibiotic Stewardship, University of California Davis

This talk will discuss gaps and opportunities in targeting therapy in ED and other outpatient settings.


9:00 Case Presentations: Pros and Cons to Rapid Susceptibility Testing

Dien_Bard_JenniferJennifer Dien Bard, PhD, D(ABMM), Director of the Clinical Microbiology Laboratory, Associate Professor of Pathology (Clinical Scholar), Keck School of Medicine, University of Southern California

Providers often depend on a pathogen’s susceptibility profile to ensure optimal antimicrobial therapy. A primary focus in the movement towards rapid diagnostics is rapid susceptibility testing. But does susceptibility result provided expeditiously really improve clinical outcome? Is the juice worth the squeeze? This session will provide case examples of the benefits and limitations of rapid susceptibility testing in the clinical laboratory.

9:30 PANEL DISCUSSION: Rapid Susceptibility Testing: Is the Value Proposition Changing?

Moderator:
Ledeboer_NathanNathan Ledeboer, PhD, Professor and Vice Chair, Pathology and Medical Director, Medical College of Wisconsin


Panelists:
Dien_Bard_JenniferJennifer Dien Bard, PhD, D(ABMM), Director of the Clinical Microbiology Laboratory, Associate Professor of Pathology (Clinical Scholar), Keck School of Medicine, University of Southern California


May_LarissaLarissa May, MD, MSPH, MSHS, Professor, Emergency Medicine; Director, Emergency Department Antibiotic Stewardship, University of California Davis


She_RosemaryRosemary She, MD, Associate Professor, Clinical Pathology, Keck School of Medicine, University of Southern California

This panel of experts will discuss the latest guidelines and advances in rapid susceptibility testing, evaluating if the value proposition is changing.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

REIMBURSEMENT FOR INFECTIOUS DISEASE DIAGNOSTICS
Continental 6

Chairperson: Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories

11:15 Precision Medicine: Advocacy and Lobbying In a Screening Population

Danielle ScelfoDanielle Scelfo, Senior Director, Health Policy and Reimbursement, Hologic

Precision medicine and the promise of liquid biopsy means that we may see a transition in application of our personalized medicine tools from companion diagnostics guiding treatment decisions and monitoring into a screening population. While reimbursement challenges in the companion diagnostic setting is more readily understood, there are a different set of challenges that exist within a screening population and the recommendations that determine coverage and reimbursement. The Affordable Care Act requires insurers to cover all preventative services with a USPSTF rating “A” or “B” without cost sharing. This session will provide an overview of the Task Force Guideline role in establishing screening recommendations and outline key challenges that diagnostics face when under review by the United States Preventative Services Task Force.

11:45 Reimbursement Challenges for Multiplex Platforms in Infectious Disease Applications: More Pathogens, More Problems?

Sheives_PaulPaul Sheives, Medical Director, Diagnostics Lead, Medical Affairs, Roche

Recent innovations in technology allow for the testing of multiple pathogens in the same sample. In many cases, the shared epidemiology and coexistence of overlapping symptoms present strong arguments for inclusion of multiple pathogens in the same panel. However, considerations beginning with conception and throughout the product life-cycle must take into account the impact of adding additional pathogens to reimbursement for these tests. Although these considerations extend to panel testing outside of the infectious disease space, this session will explore recent decisions by payors on panel testing for infectious diseases, identify the key concerns payors express, and provide direction on how to ensure successful strategies for coding, coverage and payment for multiplex panel tests.

12:15 pm Proprietary Laboratory Analyses: Perspectives Two Years Down the Road – More Questions Than Answers

Hilborne_LeeLee H. Hilborne, MD, Professor of Pathology and Laboratory Medicine, David Geffen School of Medicine, UCLA, Medical Director, Quest Diagnostics, and Deputy Director for Global Health, RAND Corporation

It has now been two years since the American Medical Association CPT Editorial Panel established the Proprietary Laboratory Analysis (PLA) and the PLA Technical Advisory Group (PLA-TAG). Since its inception, there have been about 100 codes requested by laboratory providers. Although not initially anticipated, CMS has established payment rates on the Clinical Laboratory Fee Schedule for many of the initial PLA Codes. As we discuss new and emerging technologies at this session, it is important to identify the most effective way to be reimbursed for the legitimate services we provide. PLA codes represent the newest and fastest strategy to obtain a CPT/HCPCS code. Although there are limitations, this strategy is essential for some emerging diagnostics, particularly those classified as ADLTs under PAMA.

12:45 Close of Symposium

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