Cambridge Healthtech’s 11^th Annual

Molecular Diagnostics for Infectious Disease

Improving Clinical Outcomes through Molecular Testing

August 21-22, 2019

In the current diagnostics market, molecular diagnostics for infectious disease testing offers one of the brightest areas for growth and innovation. The Eleventh Annual Molecular Diagnostics for Infectious Disease will showcase novel technologies, which are continuing to emerge and significantly reducing the time it takes to diagnose infectious diseases. However there still remains questions on reimbursement models and clinical utility for these new diagnostics. Presentations will address the question of how to design studies to best address clinical utility of new technologies. Special consideration will be given to antibiotic stewardship and antimicrobial susceptibility testing.

Final Agenda

WEDNESDAY, AUGUST 21

10:30 am Registration

Constitution A&B
11:30 Plenary Keynote Session

11:30 Chairperson’s Remarks

Charles Mathews, Principal, ClearView Healthcare Partners

11:40 NEW: Plenary Keynote Presentation: FDA Updates: Now and Looking to the Future

Katherine Donigan, PhD, Acting Director of Personalized Medicine, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Introduction and background of the new Office Director of OIR and updates on precision medicine and other initiatives at the FDA.

12:10-1:05 pm Plenary Keynote Discussion: Proposals and Solutions for Diagnostic Reform Including Oversight of Laboratory Developed Tests (LDTs)

Moderator:
Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition

• How are stakeholders influencing congressional activity on the Verifying Accurate Leading-edge IVCT Development (VALID) Act?
• How will the VALID Act change the current oversight landscape for diagnostics, including LDTs?
• How are policymakers addressing the role of CMS and CLIA in the VALID Act?
• How will increased regulatory and oversight activities at the FDA affect the diagnostics industry?
• What impact will changes in diagnostics regulation and oversight have on patient care?

Panelists:

Julie Khani, MPA, President, American Clinical Laboratory Association (ACLA)

Donald E. Horton, Jr., Senior Vice President, Global Government Relations & Public Policy, Laboratory Corporation of America Holdings

Susan Van Meter, Executive Director, AdvaMedDx

Tara Burke, PhD, Senior Director, Public Policy & Advocacy, Association for Molecular Pathology (AMP)

Laura Lasiter, PhD, Science Policy Analyst, Friends of Cancer Research

1:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:35 Ice Cream & Cookie Break in the Exhibit Hall with Poster Viewing

ANTIMICROBIAL SUSCEPTIBILITY TESTING
Independence H-I

2:05 Chairperson’s Opening Remarks

Amy J. Mathers, MD, D(ABMM), Medical Director, Antimicrobial Stewardship & Associate Director, Clinical Microbiology, Infectious Diseases & International Health University of Virginia School of Medicine

2:10 Managing Current and Future Hurdles in Implementing Novel Microbiology Diagnostics for Improved Antimicrobial Stewardship

Amy J. Mathers, MD, D(ABMM), Medical Director, Antimicrobial Stewardship & Associate Director, Clinical Microbiology, Infectious Diseases & International Health University of Virginia School of Medicine

With several novel and emerging technologies entering the clinical microbiology field to assist with decreasing the time to identification and antimicrobial susceptibility testing it can be challenging to navigate the potential application and barriers for each one. This session will explore some of the technical hurdles found in the clinical microbiology laboratory as well as some of the deployment challenges with getting results to expedite changes in patient care.

2:40 How Inkjet Printing Can Defeat Multi-Drug Resistant Superbugs

James E. Kirby, MD, D(ABMM), Director, Clinical Microbiology Laboratory, Beth Israel Deaconess Medical Center; Program Director, Medical Microbiology Fellowships, Beth Israel Deaconess Medical Center; Associate Professor of Pathology, Harvard Medical School

Emerging antimicrobial resistance has led to a critical need to identify antibiotics that are active against infections as quickly as possible. Dr. Kirby will discuss the MAST (microscopy-based antimicrobial susceptibility testing) platform, which makes use of inkjet printing, advanced microscopy, and machine learning technologies to determine the susceptibility of pathogens to any antimicrobial at will in under 4 hours, thereby addressing the antimicrobial testing gap.

3:10 Phenotypic Antibiotic Susceptibility Testing: From Monte-Carlo to the Bedside

Christopher Doern, PhD, D(ABMM), Associate Director, Microbiology, Virginia Commonwealth University Medical Center, Medical College of Virginia Campus

This talk will provide an in depth discussion of phenotypic AST methods and the various ways in which they are used. We will cover the role of AST in breakpoint development as well as the role in predicting individual patient outcomes. Along the way we’ll highlight the strengths and weaknesses of phenotypic assessment of antimicrobial susceptibility.

3:40 Sample-to-Result MDx in Less Than 15 Minutes 

Sally McFall, PhD, Director of Research of the Center for Innovation in Global Health Technologies, Biomedical Engineering, Northwestern University

Point-of-care molecular diagnostics for infectious diseases are used to guide treatment decisions and improve outcomes. Minute Molecular Diagnostics, M2Dx, has developed fast sample prep and PCR technologies that enable sample-to-result turnaround times of less than 15 minutes. Functionality will be demonstrated with influenza and chlamydia assays.

3:55 Real-Time Phenotypic Antibiotic Susceptibility Testing (AST) at the Point of Care 

Johan Elf, PhD, Stratec

Astrego’s disruptive technology makes it possible to capture individual bacterial cells from complex samples on a microfluidic chip and measure their growth rates in real-time.   Each channel can be loaded with antibiotic concentrations of choice and the effect on growth rate can be measured real time and almost immediately.  Results may be expected within 20 minutes as the effects of antibiotics on growth rates of rods and cocci is immediate.  This enables the fastest possible Antibiotic Susceptibility Test (AST), independent of McFarland concentration.

4:10 Refreshment Break in the Exhibit Hall with Poster Viewing

REIMBURSEMENT OF MOLECULAR TESTS
Independence H-I

4:55 NEW: Chairperson’s Remarks

Susan Butler-Wu, PhD, D(ABMM), Associate Professor of Clinical Pathology, Keck School of Medicine, University of Southern California, Director of Clinical Microbiology, LAC+USC Medical Center (AMP Economics Affairs Committee Member; AMP Member)

5:00 NEW: Financial Challenges and New Test Implementation: A Laboratory Perspective

Susan Butler-Wu, PhD, D(ABMM), Associate Professor of Clinical Pathology, Keck School of Medicine, University of Southern California, Director of Clinical Microbiology, LAC+USC Medical Center (AMP Economics Affairs Committee Member; AMP Member)

5:30 From Palmetto to PAMA: Recent Changes in Reimbursement for Infectious Diseases Diagnostics

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 (AMP Member)

On January 1, 2019 outpatient clinical laboratory tests received the second of three expected 10% reimbursement cuts under the Protecting Access to Medicare Act (PAMA). In addition, Medicare contractor Palmetto GBA issued local coverage determinations (LCDs) that limited coverage for syndromic multiplexed molecular infectious diseases tests. This session will describe recent reimbursement changes under the Centers for Medicare and Medicaid Services (CMS) and discuss the potential impact on clinical laboratories.

5:50 CANCELLED: Reimbursement Woes from the Perspective of a Laboratorian

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 (AMP Infectious Diseases Subdivision Representative to the Program Committee; AMP Member)

Paradoxal to the vast array of innovative molecular diagnostic tests becoming available, securing reimbursement for such tests is becoming increasingly difficult. The ability to prove clinical utility is paramount in order to justify coverage and requires collaborative efforts between multiple disciplines, including diagnostic companies, clinical laboratories and providers. Failure to secure coverage directly impacts the clinical laboratories’ ability to implement novel diagnostic tests. This presentation will discuss the challenges that laboratories face in balancing implementation of molecular tests to conform to best practices versus reimbursement woes.

6:00 An Update on Coverage and Reimbursement from AMP’s Economic Affairs Committee

Samuel K. Caughron, MD, FCAP, Director, MAWD Molecular Lab, MAWD Pathology Group (AMP Economic Affairs Committee Chair and Representative to the AMP 2018 Board of Directors; AMP Member)

6:30 Close of Day

6:30 Dinner Short Course Registration

6:45 - 9:15 pm NEW: Recommended dinner Short Course*

SC16: Development of Novel Diagnostics for Antimicrobial Resistance

Charles L Fromer, Diagnostics Team Leader, Diagnostics and Detection Division, Chemical and Biological Technologies Department Research and Development Directorate, Defense Threat Reduction Agency

Diane L. Dutt, PhD, PMP, Science and Technology Manager, Diagnostics and Detection Division, Defense Threat Reduction Agency

Stephen C. Francesconi, PhD, Diagnostics and Detection Division, Defense Threat Reduction Agency

*Separate registration required.

thurSDAY, AUGUST 22

7:15 am Registration

Independence B-E and Foyer
7:30 Problem Solving Breakout Discussions with Continental Breakfast

Strengths and Limitations of AI and Machine Learning for Healthcare Applications

Moderators: Hooman H. Rashidi, MD, FASCP, Professor and Vice Chair, GME, Director of Residency Program; Director, Flow Cytometry & Immunology, Department of Pathology and Laboratory Medicine, University of California, Davis School of Medicine

Nam Tran, PhD, Associate Clinical Professor, Clinical Chemistry, Special Chemistry, Toxicology, Point-of-Care Testing, SARC Sections, Pathology and Laboratory Medicine, University of California, Davis

• Data collection challenges
• Data processing limitations
• Highlights and limitations of various machine learning algorithms
• Regulatory considerations and barriers
  
• Generalizability of laboratory data for AI/ML applications

Overcoming the Challenges of Point-of-Care Diagnostics for Better Antibiotic Stewardship

Moderator: Kfir Oved, PhD, Co-founder, CTO, Chairman, MeMed Dx

DEVELOPING AND IMPLEMENTING NEW TECHNOLOGY
Independence H-I

8:25 Chairperson’s Remarks

Kfir Oved, PhD, CTO, MeMed, Israel

8:30 Diagnostic Stewardship and Implementation of New Tests for Infectious Diseases in the Emergency Department

Larissa May, MD, MSPH, MSHS, Director, Emergency Department, Outpatient Antibiotic Stewardship, University of California Davis

This presentation will highlight the importance of diagnostic stewardship in parallel with antibiotic stewardship and opportunities and challenges with implementation of new infectious disease diagnostic tests in the ED and other acute episodic care settings.

9:00 Viral Load Testing for CMV: The Quagmire Continues

Christopher Polage, MD, MAS, Medical Director, Duke University Health Systems Clinical Microbiology Laboratory; Associate Processor, Duke University Medical Center

Variability in cytomegalovirus (CMV) viral load results between laboratories and assays remains a barrier to standardizing treatment protocols and defining disease despite efforts to harmonize tests. Differences in assay design may be part of the problem.

9:30 Sensitive Sequencing Approaches for Metagenomics, Infectious Disease and Forensic Applications. 

Shawn Levy, PhD, CSO, Genomics, Discovery Life Sciences

10:00 Coffee Break in the Exhibit Hall with Poster Viewing

AI-BASED INFECTIOUS DISEASE DIAGNOSTICS
Independence H-I

11:00 Chairperson’s Remarks

James Courtney Fackler, MD, Director, Pediatric Critical Care Medicine, Associate Professor of Anesthesiology and Critical Medicine, Johns Hopkins Medicine

11:05 Harnessing the Host Response for Real Time Infectious Disease Diagnosis

Ephraim 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.

11:35 CO-PRESENTATION: Burn Sepsis and Acute Kidney Injury: Unique Population and the Promise of Artificial Intelligence

Hooman H. Rashidi, MD, FASCP, Professor and Vice Chair, GME, Director of Residency Program; Director, Flow Cytometry & Immunology, Department of Pathology and Laboratory Medicine, University of California, Davis School of Medicine

Nam Tran, PhD, Associate Clinical Professor, Clinical Chemistry, Special Chemistry, Toxicology, Point-of-Care Testing, SARC Sections, Pathology and Laboratory Medicine, University of California, Davis

Burn patients are at high risk for sepsis. Acute kidney injury (AKI) is common in burn sepsis patients. Early recognition of AKI is impeded by the poor performance biomarkers such as urine output and creatinine. Artificial intelligence (AI) could be used to augment the performance of current biomarkers of AKI. Our study evaluates the clinical utility of AI in detecting sepsis vs. non-sepsis related AKI in severely burned patients.

12:05 pm Integrating Artificial Intelligence Technologies into Clinical Care for Infectious Disease

James Courtney Fackler, MD, Director, Pediatric Critical Care Medicine, Associate Professor of Anesthesiology and Critical Medicine, Johns Hopkins Medicine

AI techniques (e.g., deep learning) are finding patterns in data that humans can not routinely see. The opportunity for improved health care value is early diagnosis and intervention. The key, however, to delivering this value will be optimizing and managing the symbiosis between the AI machines and the expert clinician.

12:35 The Key™ to Making an Impact: Accurate, Actionable, and Fast Host Response-based Diagnostics 

Kfir Oved, PhD, CTO, MeMed

Antibiotic overuse drives AMR. Accurately differentiating bacterial from viral infection is essential to improve antibiotic stewardship. For this, we developed and validated a pioneering test (MeMedBV™) that integrates levels of three host-proteins into a score with >90% accuracy in differentiating bacterial from viral infections. We also developed a novel POC platform (MeMedKey™) that runs BV™ in 15 minutes. BV™ on Key™, a rapid and actionable diagnostic, enables physicians to better manage patients while combating AMR.

1:05 Enjoy Lunch on Your Own

1:35 Dessert Break in the Exhibit Hall with Poster Viewing

NGS AND CLINICAL METAGENOMIC SEQUENCING
Independence H-I

2:15 Chairperson’s Remarks

Heike Sichtig, PhD, Principal Investigator and Team Lead, Microbiology Devices, Center for Devices (CDRH), FDA

2:20 Clinical Metagenomic Sequencing – New Technologies and Advances in the Near Future

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 potentially game-changing technology for infectious disease diagnosis as it enables detection of nearly all pathogens in a single assay. This approach has been made feasible by the rapid advances in sequencing technology, bioinformatics analysis, and reference databases. In this talk I will discuss how we overcome challenges in development and validation of an mNGS-based assay in a CLIA laboratory regulatory environment. I will discuss efforts to expand clinical mNGS validation and testing to new body fluids, as well as new transformative technologies including CRISPR-Cas and spiked primer enrichment strategies, and machine learning-based identification of host biomarkers.

2:40 Clinical Utility of Next-Generation Sequencing for Infectious Disease Diagnosis

Esther Babady, PhD, Director, Clinical Microbiology Operations, Memorial Sloan Kettering Cancer Center

The use of next generation sequencing (NGS) for infectious disease diagnosis has recently become a reality. Although not widely available in most laboratories, a few studies have highlighted the impact and potential utility of NGS in patient care. However, the optimal approach to implementing this powerful method for optimal impact remains unclear. This presentation will review the current state of NGS for the diagnosis and management of infectious diseases and discuss options for implementation that could maximize its clinical utility.

3:00 The Challenges and Opportunities of In-House NGS in Clinical Microbiology versus the Reference Lab Model

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

Clinical labs are increasingly considering the use of NGS for detection of infectious diseases, a technique that has largely been confined to select reference labs and public health labs. This session will focus on the challenges and opportunities for a hospital based laboratory in implementing NGS for detection of infectious diseases.

3:20 PANEL DISCUSSION: Commercialization and Validation of NGS Diagnostics

Moderator: Heike Sichtig, PhD, Principal Investigator and Team Lead, Microbiology Devices, Center for Devices (CDRH), FDA

Panelists: 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

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

• FDA submission guidelines and submission strategies
• Comparative methods
• Lab validation vs point-of-care
• Strategies around regulation and commercialization

4:20 End of Summit