Cambridge Healthtech Institute’s 12th Annual

Advanced Diagnostics for Infectious Disease

Improving Clinical Outcomes Through Novel Technology and Molecular Testing

August 26-27, 2020


In the current diagnostics market, molecular diagnostics for infectious disease testing offer one of the brightest areas for growth and innovation. Advances in technology have opened opportunities for new targets, and rapid molecular tests have greatly reduced the time it takes to diagnose infectious disease. At Cambridge Healthtech Institute’s Twelfth Annual Advanced Diagnostics for Infectious Disease, leaders working in the clinical lab, research, biotech, and pharma will converge to showcase the latest in diagnostic technology and discuss the biggest challenges facing the clinical lab, including reimbursement, implementing tests into a clinical workflow, and more. Special consideration will be given to antibiotic resistance, rapid tests for sepsis, next-generation sequencing, clinical metagenomic sequencing and multiplex molecular panels.

Final Agenda

WEDNESDAY, AUGUST 26

Plenary Keynote Session

11:30 AM Chairperson’s Remarks

11:35 Diagnostic Technologies that Will Shape Precision Medicine in 2020 and Beyond

David Walt, PhD, Hansjörg Wyss Professor, Biologically Inspired Engineering, Harvard Medical School; Professor, Department of Pathology, Brigham and Women’s Hospital; Core Faculty, Wyss Institute for Bioinspired Engineering, Harvard University, HHMI Professor

Precision medicine is being driven by the ability to measure biomarkers at an unprecedented scale. New technologies that enable the measurement of proteomic and genomic signatures, engineered nanomaterials for diagnostics and imaging, smart watches, and new imaging modalities provide personalized profiling that can be used to guide therapies. In order for these technologies to have the greatest benefit, there will need to be profound changes in the entire diagnostics ecosystem.

12:05 PM PANEL DISCUSSION: What Technologies Will Shape Precision Medicine in 2020?

Moderator: Susan Hsiao, MD, PhD, Assistant Professor, Pathology and Cell Biology, Columbia University Medical Center

Panelists: Jonathan Nowak, MD, PhD, Assistant Professor, Pathology, Harvard Medical School; Associate Pathologist, Brigham and Women’s Hospital

David Walt, PhD, Hansjörg Wyss Professor, Biologically Inspired Engineering, Harvard Medical School; Professor, Department of Pathology, Brigham and Women’s Hospital; Core Faculty, Wyss Institute for Bioinspired Engineering, Harvard University, HHMI Professor

What is the clinical impact of some of the following technologies and what are the current bottlenecks and challenges that need to be surmounted? Examples of each will be given:

  • RNA sequencing
  • Single-cell sequencing and analysis
  • AI and machine learning
  • Tumor mutational burden measurement
  • Emerging uses of NGS
  • Tumor microenvironment
  • Multi-modality and transcriptomics
  • Microbiome

12: 35 Plenary Keynote Introduction

Charles Mathews, Principal, ClearView Healthcare Partners

12:45-1:15 Fireside Chat

Moderator: Charles Mathews, Principal, ClearView Healthcare Partners

Sara Brenner, MD, MPH, Associate Director for Medical Affairs; CMO, In Vitro Diagnostics, Office of In Vitro Diagnostics & Radiological Health (OIR), Office of Product Evaluation & Quality (OPEQ), Center for Devices & Radiological Health (CDRH), U.S. Food & Drug Administration

1:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:45 Refreshment Break in the Exhibit Hall with Poster Viewing

DEVELOPING AND SHOWING CLINICAL IMPACT OF RAPID DIAGNOSTICS

2:15 Chairperson’s Opening Remarks

Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and Virology, Children’s Hospital Los Angeles; Associate Professor, Pathology and Laboratory Medicine, Keck School of Medicine, University of Southern California

2:20 Clinical Impact of Rapid Molecular Blood Culture Test at a Tertiary Cancer Care Center

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

Sepsis remains a significant cause of morbidity and mortality in hospitalized patients. Cancer patients and other immunocompromised hosts are particularly at increased risk of sepsis. Novel molecular methods for rapid diagnosis directly from blood samples are now available for identification of pathogens and select resistance markers. This presentation will review the clinical impact of rapid molecular tests on patient outcomes at a tertiary cancer care center.

2:50 What’s New in the Molecular Detection of Bloodstream Infections?

Kimberly Hanson, MD, MHS, Director, Transplant Infectious Diseases and Immunocompromised Host Service; Director, Medical Microbiology Fellowship Program, Section Head, Clinical Microbiology, University of Utah, ARUP Laboratories

Delayed diagnosis of bloodstream infections (BSI) is associated with poor clinical outcomes. This session will review the current landscape of BSI molecular diagnostic testing, including rapid pathogen identification, antimicrobial drug resistance detection, and the potential utility of host response signatures.

3:20 DOD’s Pursuit of Pre-Symptomatic Non-Invasive Diagnostics

Edward Argenta, Science & Technology Manager, Biological & Chemical Technologies, Defense Threat Reduction Agency

The Department of Defense, Chemical and Biological Technologies Department is managing a disruptive portfolio developing algorithms utilizing artificial intelligence approaches to deliver warning of an acute exposure to a pathogen or toxic chemical prior to overt signs and symptoms using non-invasive biomarkers. The portfolio has shown successes in both animal and human exposure studies, and will continue to pursue advancing the research to provide early identification of exposure.

3:50 Presentation to be Announced

4:05 Presentation to be Announced

4:20 Refreshment Break in the Exhibit Hall with Poster Viewing

MULTIPLEX PANELS

5:05 Chairperson’s Remarks

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

5:10 Head-to-Head Comparison: Nanopore Sequencing and Microarray Resequencing for Multiplex Pathogen Identification

Robert Duncan, PhD, Principal Investigator, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), FDA

GeneChip Resequencing microarrays have been advanced for infectious disease agent detection and identification from Ebola to Zika. Next-generation sequencing with the highly mobile and cost-effective nanopore sequencing device is challenging the supremacy of the microarray in rapid point-of-need pathogen detection. This talk will present results of side-by-side application of these two platforms for detection in pathogen-spiked blood samples and compare their performance.

5:30 Syndromic Testing for Meningitis/Encephalitis: Saga of the Love-Hate Relationship

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

As part of the Multiplex Panel session, this talk will focus on multiplex testing for the laboratory diagnosis of meningitis and encephalitis as compared to standard-of-care testing. The potential benefits and limitations of panel testing for meningitis and encephalitis compared to standard-of-care testing will be discussed. The potential approaches to maximize testing yield will also be discussed.

5:50 The Biofire Pneumonia Panel: Does It Relate to Microbiological and Clinical Variables?

Kenneth Rand, MD, Medical Director, Clinical Microbiology Laboratory; Professor, Pathology and Medicine, University of Florida

The BioFire FilmArray Pneumonia Panel (PP) detects 15 common bacterial pathogens semi-quantitatively (copy # from 104 to 107), 3 atypical pneumonia bacteria, 8 viruses, and 7 antimicrobial resistance markers by multiplex PCR in about 1 hour in the laboratory. Results of our 396-patient study suggest PP detects more bacterial isolates than conventional microbiology, and the copy number correlates with outcome variables, such as ICU length of stay, temperature, and white cells in the BAL. Results reported in a 3–4 h timeframe after a BAL could potentially improve both antibiotic choice and de-escalation in critically ill intubated patients.

6:10 PANEL DISCUSSION: Advancing Multiplex Panels for Clinical Diagnostics

Moderator: Esther Babady, PhD, Medical Director, Clinical Microbiology Service, Memorial Sloan Kettering Cancer Center

Panelists: Robert Duncan, PhD, Principal Investigator, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), FDA

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

Kenneth Rand, MD, Medical Director, Clinical Microbiology Laboratory; Professor, Pathology and Medicine, University of Florida

Tim Blauwkamp, PhD, CSO, Karius

  • Comparison of multiplex platforms
  • Reimbursement considerations
  • Proving clinical utility of multiplex diagnostic tests

6:40 Close of Day

6:40 Dinner Short Course Registration*

7:00 - 9:30 Dinner Short Course*

Recommended Dinner Short Course*

SC8: The COVID-19 Case Study: Accelerated Development of Diagnostics for Novel Infectious Disease Threats

*Separate registration required.

THURSDAY, AUGUST 27

7:15 am Registration

7:30 Problem Solving Breakout Discussions with Continental Breakfast

CONSIDERATIONS FOR AMR DIAGNOSTICS

8:25 Chairperson’s Remarks

Chairperson to be Announced, MeMed

8:30 I Don’t Watch Reality TV, I Live It – Reimbursement Challenges under PAMA

Ester Stein, MBA, Director, Corporate Reimbursement, Government Affairs, Abbott

This talk will focus on the reimbursement challenges under PAMA for the more commonly performed diagnostic tests. The talk will focus primarily on coding and payment issues, and will provide policy updates.

8:45 Don’t Take That Antibiotic! You Might Get...Fat? The Science of the Microbiome

Norman Moore, PhD, Director, Scientific Affairs, Abbott

Even though the global threat of antibiotic-resistant microorganisms is significant, many patients demand antibiotics and doctors are far too willing to provide them. This talk shows that the relationship between us and our bacteria is more important than previously thought. Disrupting that balance can cause a host of medical issues.

9:30 Serum Epitope Repertoire Analysis (SERA): A Novel Serology Platform Enabling Multiplex Diagnostics and Sero-Surveillance

Kathy Kamath, PhD, Director, Discovery, Research & Development, Serimmune Inc.

SERA incorporates bacterial display peptide libraries, NGS, and custom bioinformatics to profile antibody repertoires and map them to infectious and other diseases. The platform enables parallel testing of an unlimited number of biomarkers in a single, universal assay, and quantitative longitudinal monitoring of that response as it evolves over time.

9:45 Sponsored Presentation (Opportunity Available)

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

DIAGNOSTIC STEWARDSHIP

11:00 Chairperson’s Remarks

Joseph Campos, PhD, D(ABMM), F(AAM), Director, Microbiology Laboratory, Infectious Disease Molecular Diagnostics Laboratory, Laboratory Informatics, Children’s National Medical Center; Strategic Alliances Liaison and Former Secretary, ASM

11:05 Diagnostic Stewardship: Because You Can’t Do Everything for Everyone All the Time

Christopher Doern, PhD, D(ABMM), Associate Director, Microbiology, Virginia Commonwealth University Medical Center, Medical College of Virginia Campus; Co-Chair, ASM’s Clinical Micro Open

11:25 The Role of Diagnostic Stewardship in Improving Patient Care and Reducing Overall Healthcare Costs

Matthew Binnicker, PhD, Consultant, Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology; Vice Chair of Supply Chain Management, Department of Laboratory Medicine and Pathology; Vice Chair of Practice, Department of Laboratory Medicine/Pathology, Mayo Clinic; Chair, ASM’s Professional Development Subcommittee

Healthcare is transitioning from a fee-for-service model to one focused on value-based care. As a key component of patient care and the value-based equation, clinical laboratories will need to be an active participant in the development of diagnostic stewardship programs, so that healthcare providers are guided towards the “right test, for the right patient, at the right time.” This presentation will provide an overview of establishing an effective diagnostic stewardship program, and provide examples of how healthcare providers can be guided towards appropriate testing and result interpretation. Specific case scenarios will be reviewed to demonstrate how diagnostic stewardship can lead to increased efficiency, reduced cost, and improved patient care.

11:55 A Laboratory Medicine Best Practices Systematic Review and Meta-Analysis for the Laboratory Diagnosis of C. Difficile

Colleen Kraft, MD, Associate Chief Medical Officer, Associate Professor, Pathology/Laboratory Medicine, Medicine/Division of Infectious Diseases, Emory University Hospital; Chair, ASM’s Evidence-Based Laboratory Medicine Practice Guidelines

12:05 pm PANEL DISCUSSION: Extended Q&A with Session Speakers

Moderator: Joseph Campos, PhD, D(ABMM), F(AAM), Director, Microbiology Laboratory, Infectious Disease Molecular Diagnostics Laboratory, Laboratory Informatics, Children’s National Medical Center; Strategic Alliances Liaison and Former Secretary, ASM

Panelists: Speakers of the Session

12:35 Presentation to be Announced

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

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

CLINICAL METAGENOMIC SEQUENCING

2:15 Chairperson’s Remarks

Norman Moore, PhD, Director, Scientific Affairs, Abbott

2:20 Clinical Metagenomic Sequencing and Human Host Response: Changing the Diagnostic Paradigm?

Charles Chiu, MD, PhD, Professor, Laboratory Medicine and Medicine/Infectious Diseases, Director, UCSF-Abbott Viral Diagnostics and Discovery Center, Associate Director, UCSF Clinical Microbiology Laboratory, UCSF School of Medicine

Metagenomic next-generation sequencing (mNGS) is a transformative technology for infectious disease diagnosis as it enables detection of nearly all pathogens – viruses, bacteria, fungi, and parasites – in a single assay. Here we will discuss the integration of multiple approaches to enhance the clinical utility of body fluid mNGS, including nanopore sequencing, CRISPR-Cas12-based pathogen detection, complementary host response analyses, and simultaneous diagnosis of cancer.

2:50 Mycobacterial Infections in Immunocompromised Patients, the Perfect Fit for Metagenomic Solutions

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

DETECTION OF RESISTANCE

3:20 Applying Next-Generation Sequencing for Detection of Antimicrobial Resistance

Patricia Simner, PhD, D(ABMM), Associate Professor, Pathology; Director, Bacteriology, Division of Medical Microbiology, The Johns Hopkins University School of Medicine

3:50 FLASH: A Next-Generation CRISPR Diagnostic for Multiplexed Detection of Antimicrobial Resistance Sequences

Emily Crawford, PhD, Scientist II, Infectious Disease Initiative, Chan Zuckerberg Biohub

4:20 End of Summit



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