Cambridge Healthtech Institute’s 12th Annual

Advanced Diagnostics for Infectious Disease

Improving Clinical Outcomes Through Novel Technology and Molecular Testing

August 26 - 27, 2020 ALL TIMES EDT

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.

Wednesday, August 26

PLENARY KEYNOTE SESSION

11:10 am

Organizer's Opening Remarks

Christina Lingham, Executive Director, Conferences and Fellow, Cambridge Healthtech Institute
11:15 am

Ultrasensitive SARS-CoV-2 Protein Assays for Precision Clinical Decisions

 

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

We have developed ultrasensitive single molecule assays for multiple relevant SAR-CoV-2 proteins that can detect both active virus and prior infection. The assays have been tested in thousands of individuals, including patients and healthcare workers and exhibit exceptional sensitivity and specificity. Additionally, we have followed these protein concentrations over time during the course of disease in many patients and can predict outcomes based on the dynamics of the protein responses.

 

11:40 am PANEL DISCUSSION :

Lessons Learned for Diagnostic Testing During the COVID-19 Pandemic

Panel Moderator:
Susan Hsiao, MD, PhD, Assistant Professor, Pathology and Cell Biology, Columbia University Medical Center
  • Supply chain challenges
  • Navigating and validating multiple platforms
  • Reimbursement
  • Value of distributed testing
  • Value of tests available: PCR vs. antigen vs. serology
  • Developing sustainable testing protocols
Panelists:
Alex Greninger, MD, PhD, MS, MPhil, Assistant Professor, Laboratory Medicine, University of Washington
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 at Hofstra/Northwell
David Walt, PhD, HHMI Professor; Hansjörg Wyss Professor of Biologically Inspired Engineering, Harvard Medical School; Professor of Pathology, Department of Pathology-Brigham and Women’s Hospital; Core Faculty, Wyss Institute for Bioinspired Engineering, Harvard University
Charles Mathews, Principal, ClearView Healthcare Partners
12:30 pm Fireside Chat
Panel Moderator:
Charles Mathews, Principal, ClearView Healthcare Partners
Panelists:
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
12:55 pm Lunch Break - View our Virtual Exhibit Hall
Joe Jiang, Product Manager, Product Development, ACROBiosystems

High-quality recombinant SARS-CoV-2 antigens and antibodies are key reagents in the development of SARS-CoV-2 serological test kits. ACROBiosystems has developed a series of SARS-CoV-2 antigen and antibody products that can be used in serological tests. 

DEVELOPING AND SHOWING CLINICAL IMPACT OF RAPID DIAGNOSTICS

1:30 pm Clinical Impact of Rapid Molecular Blood Culture Test at a Tertiary Cancer Care Center
Esther Babady, PhD, D(ABMM), FIDSA, Section Head, 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.

1:50 pm DOD’s Pursuit of Pre-Symptomatic Non-Invasive Diagnostics
Edward Argenta, Science & Technology Mgr, Biological & Chemical Technologies, Defense Threat Reduction Agcy

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.

Glen Hansen, MD
2:35 pm PANEL DISCUSSION:

The Challenges in Testing for COVID-19 and How do we Learn for the Next Pandemic

Panel Moderator:
Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and Medical Director, Medical College of Wisconsin
  • Supply shortages, what can labs and the government do to be better prepared in an era of just in time shipping
  • Regulatory changes, what changes are needed to ensure testing is not limited for the next pandemic? 
  • Some foundations such as Gates and Rockefeller are considering developing surveillance networks
  • As we increasingly move to FDA cleared products, are we losing the ability to develop our own tests?
  • What is the role of NGS-based assays in mass surveillance 
  • How do we solve the extraction challenge?
  • Test performance was a major issue in COVID-19, what can we learn?
Panelists:
Norman Moore, PhD, Director, Scientific Affairs, Abbott
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
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
Emily Crawford, PhD, Scientist II, Infectious Disease Initiative, Chan Zuckerberg Biohub
Glen Hansen, MD
2:55 pm Refresh Break - View our Virtual Exhibit Hall

DIAGNOSTIC STEWARDSHIP

3:10 pm

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
3:15 pm 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
3:35 pm 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.

3:55 pm

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
4:15 pm LIVE Q&A:

Session Wrap-Up

Panel 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:
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
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
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
4:35 pm Happy Hour - View our Virtual Exhibit Hall
5:10 pm Close of Day

Thursday, August 27

MULTIPLEX PANELS

9:00 am

Chairperson's Remarks

Esther Babady, PhD, D(ABMM), FIDSA, Section Head, Clinical Microbiology Service, Memorial Sloan Kettering Cancer Center
9:05 am

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.

9:20 am 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.

9:35 am 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.

9:50 am PANEL DISCUSSION : Advancing Multiplex Panels for Clinical Diagnostics
Panel Moderator:
Esther Babady, PhD, D(ABMM), FIDSA, Section Head, Clinical Microbiology Service, Memorial Sloan Kettering Cancer Center
  • Comparison of multiplex platforms
  • Reimbursement considerations
  • Proving clinical utility of multiplex diagnostic tests
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
10:05 am Coffee Break - View Our Virtual Exhibit Hall
10:15 am Problem Solving Discussions - View our Virtual Exhibit Hall

BREAKOUT 9: Getting a Foot in the SBIR Grant Rat Race

Robert Duncan, PhD, Principal Investigator, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), FDA
  • What defines Small Business Innovation Research?
  • What is the importance of interaction with the NIH Project Managers?
  • What is the Phase I Grant? Visualize proof of concept research.
  • What is the Phase II Grant? Visualize larger scale funding for research that leads to a commercialization plan?

BREAKOUT 8: Clinical Metagenomic Sequencing

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

CONSIDERATIONS FOR AMR DIAGNOSTICS

10:45 am

Reimbursement Challenges under PAMA for New Tests

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

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.

11:00 am 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.

Tim Blauwkamp, CSO, Karius

Karius microbial cell-free DNA sequencing from plasma (mcfDNA-Seq) is emerging as an alternative to invasive diagnostic tests for species-level identification of pathogens.  We will present consolidated results from several clinical studies to address key questions on how to use this new technology to improve patient outcomes and lower diagnostic testing costs in immunocompromised patients with suspected invasive infection.

Jiahui Yang, PhD, R&D Director, R&D, Sino Biological Inc

Antigens and antibodies are key components for serological diagnosis kits. Sino Biological used mammalian cells for antigen production to ensure proper biological activity. Antibodies against viral proteins were generated by multiple platforms, including hybridoma, phage display and B cell cloning, to achieve high sensitivity and specificity.

12:00 pm Lunch Break - View our Virtual Exhibit Hall

NEXT GENERATION AND CLINICAL METAGENOMIC SEQUENCING

12:15 pm

Chairperson's Remarks

Norman Moore, PhD, Director, Scientific Affairs, Abbott
12:20 pm FLASH: A Next-Generation CRISPR Diagnostic for Multiplexed Detection of Antimicrobial Resistance Sequences
Emily Crawford, PhD, Scientist II, Infectious Disease Initiative, Chan Zuckerberg Biohub
12:40 pm 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.

1:00 pm

Metagenomic Next-Generation Sequencing to Detect & Predict Antimicrobial Resistance

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

Initial efforts for applying metagenomic next-generation sequencing (mNGS) for infectious disease diagnostics have focused on pathogen detection. However, we can also gain information on antimicrobial resistance markers, virulence factors or even host biomarkers associated with different disease states. In this presentation, we will discuss the challenges of using mNGS for detection of antimicrobial resistance genes to predict phenotypes and discuss the current status of mNGS for detection of antimicrobial resistance.

1:20 pm LIVE Q&A:

Session Wrap-Up

Panel Moderator:
Norman Moore, PhD, Director, Scientific Affairs, Abbott
Panelists:
Emily Crawford, PhD, Scientist II, Infectious Disease Initiative, Chan Zuckerberg Biohub
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
Patricia Simner, PhD, D(ABMM), Associate Professor, Pathology; Director, Bacteriology, Division of Medical Microbiology, The Johns Hopkins University School of Medicine
Robert Schlaberg, MD, PhD, MPH, Co-Founder, Chief Medical Officer, Medical & Scientific Affairs, IDbyDNA
1:35 pm Close of Summit