Cambridge Healthtech Institute's 9th Annual

Infectious Disease Diagnostics

Emerging Technologies in the Post-Pandemic Era

March 27 - 28, 2024 ALL TIMES PDT

The COVID-19 pandemic has fueled explosive innovation and investment in advanced technologies for infectious disease diagnostics. Cambridge Healthtech Institute’s 9th Annual Infectious Disease Diagnostics meeting will span applications in the clinic, community surveillance, pharmacy, resource-limited settings, and at-home diagnostics. Technology innovations include rapid infectious disease diagnostics and community surveillance, multiplexed testing and variant detection, antimicrobial resistance, NGS and metagenomics, host response, and more. Finally, regulatory, reimbursement, and market access strategies for advanced diagnostics in the post-pandemic era will be discussed.

Wednesday, March 27

Registration Open2:00 pm

CLINICAL UTILITY OF METAGENOMIC NEXT-GENERATION SEQUENCING FOR DIAGNOSIS OF INFECTIOUS DISEASE

2:00 pm

Chairperson's Remarks

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

2:05 pm

Clinical Metagenomic Sequencing for Rapid Diagnosis of Infections

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

Clinical metagenomic next-generation sequencing (mNGS) is an emerging approach for broad-based diagnosis of infections, whether caused by bacteria, viruses, fungi, or parasites. Here we will discuss recent improvements in turnaround time, performance, and bioinformatics that make these tests increasingly accessible to clinical and public health laboratories. We will also discuss how machine learning-based host response analyses of human RNA mNGS data can be leveraged to aid in the diagnosis of infections.

2:35 pm

Diagnosis of Invasive Fungal Infections by Microbial Metagenomics Sequencing

Esther Babady, PhD, D(ABMM), FIDSA, FAAM, Chief, Clinical Microbiology Service, Memorial Sloan Kettering Cancer Center

In high-risk oncology patients, invasive fungal infections (IFI) remain a major cause of morbidity and mortality. This is due, in part, to challenges associated with IFI diagnosis, which currently relies on a combination of risk stratification, limited laboratory methods and imaging studies. In this talk, the current data on the potential of microbial metagenomics sequencing to improve IFI diagnosis will be reviewed, including remaining gaps and future opportunities.

3:05 pm

Clinical Integration of Microbial Whole-Genome Sequencing

Shaun Yang, PhD, Associate Clinical Professor, Director, Molecular Microbiology and Pathogen Genomics Laboratory, University of California, Los Angeles

The clinical and diagnostic utility of microbial whole-genome sequencing (WGS) is vast. It includes speciation/classification of microorganisms, virulence genotyping, antimicrobial resistance (AMR) prediction, emerging pathogen and AMR mechanism surveillance, and outbreak investigation. This talk will describe the real-world implementation of microbial WGS testing and its integration into routine patient care and infection prevention practice at a large academic medical center.

Refreshment Break in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)3:35 pm

4:15 pm PANEL DISCUSSION:

Clinical Metagenomic Sequencing: Where Does It Fit in the Diagnostic Algorithm?

PANEL MODERATOR:

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

This session will provide expert recommendations and best practices regarding the use of metagenomic next-generation sequencing (mNGS) testing in clinical practice. Speakers will discuss potential clinical indications for mNGS, considering patient selection criteria, diagnostic yield, timing for test ordering, assay turnaround time, cost, as well as test and sample availability. We will also review diagnostic and antimicrobial stewardship considerations related to mNGS.

PANELISTS:

Esther Babady, PhD, D(ABMM), FIDSA, FAAM, Chief, Clinical Microbiology Service, Memorial Sloan Kettering Cancer Center

Brad Perkins, MD, CMO, Karius, Inc.

Shaun Yang, PhD, Associate Clinical Professor, Director, Molecular Microbiology and Pathogen Genomics Laboratory, University of California, Los Angeles

Steve Miller, MD, PhD, CMO, Delve Bio

Close of Day5:15 pm

Thursday, March 28

Morning Coffee8:00 am

MOLECULAR SYNDROMIC PANELS FOR RESPIRATORY PATHOGEN TESTING

8:30 am

Chairperson's Remarks

Gregory J. Berry, PhD, Associate Professor, Pathology & Cell Biology, Columbia University Vagelos College of Physicians and Surgeons

8:35 am

The Shifting Landscape of Respiratory Pathogen Testing

Gregory J. Berry, PhD, Associate Professor, Pathology & Cell Biology, Columbia University Vagelos College of Physicians and Surgeons

There are many different options available for respiratory testing, ranging from detecting a single pathogen to multiplex testing for numerous pathogens simultaneously. The choice of what pathogens to test for involves many different factors, such as the target patient population, testing setting, and what viruses are circulating at the time of testing. These factors can also dramatically change in certain circumstances, such as during the SARS-CoV-2 pandemic. The goal of this talk is to cover several different respiratory testing scenarios and what options for testing could be utilized in each case.

9:05 am PANEL DISCUSSION:

Multiplex Testing for Respiratory Pathogens—What Is the Right Fit?

PANEL MODERATOR:

Gregory J. Berry, PhD, Associate Professor, Pathology & Cell Biology, Columbia University Vagelos College of Physicians and Surgeons

There are many different molecular options for respiratory pathogen testing, ranging from detecting one to numerous pathogens simultaneously. While having many options is advantageous, the decision of which test or tests to choose can be daunting and is driven by many different variables such as the healthcare setting, patient population, and even the time of year. We plan on interactively discussing these variables and how to assess them in order to lead to the optimal testing scheme.

PANELISTS:

Alex Greninger, MD, PhD, Assistant Professor, Laboratory Medicine, University of Washington

Larissa May, MD, MSPH, MBA, Professor, Emergency Medicine; Director, Emergency Medicine Innovation and External Partnerships; Assistant Clinical Ventures Officer, UC Davis Health

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

Coffee Break in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)10:05 am

HOST RESPONSE-BASED DIAGNOSTICS FOR INFECTIOUS DISEASE

10:50 am

Chairperson's Remarks

Christopher W. Woods, MD, MPH, Professor, Medicine, Global Health & Pathology, Duke University

10:55 am

Controlled Human Infection Models in Biomarker Development for Precision Medicine

Christopher W. Woods, MD, MPH, Professor, Medicine, Global Health & Pathology, Duke University

Controlled human challenge models are ideal study designs for monitoring host:pathogen interactions for colonization and mild to moderate symptomatic infections. Active models include a diversity of respiratory viruses, dengue, norovirus, a variety of bacterial gastrointestinal and genitourinary pathogens, and malaria. Precise inoculation times and serial sampling, often under quarantine, allow for dense timepoints supporting more precise kinetics of physiological and molecular responses. In addition to efficient evaluation of potential early phase vaccines and therapeutics, inoculated individuals can serve as their own controls for digital and clinico-molecular biomarker development and validation.

11:25 am

The Host Response in Acute Infections and Sepsis: Potential Challenges and Benefits

Timothy Sweeney, MD, PhD, Co-Founder & CEO, Inflammatix, Inc.

Host-response technologies offer the promise for rapid assessments (diagnostic and prognostic) of patients with suspected acute infection and sepsis. However, improving outcomes depends on test design, performance, and implementation. We will discuss practical challenges and solutions in improving patient outcomes in this challenging patient segment.

Enjoy Lunch on Your Own11:55 am

Refreshment Break in the Exhibit Hall with Last Chance Poster Viewing1:00 pm

DIAGNOSTIC STEWARDSHIP: RIGHT TEST TO THE RIGHT PATIENT AT THE RIGHT TIME

1:40 pm

Chairperson's Remarks

Michael E. Klepser, PharmD, FCCP, FIDP, Professor, Ferris State University College of Pharmacy

1:45 pm

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

Larissa May, MD, MSPH, MBA, Professor, Emergency Medicine; Director, Emergency Medicine Innovation and External Partnerships; Assistant Clinical Ventures Officer, UC Davis Health

This session will highlight the importance of diagnostic test stewardship in parallel with antibiotic stewardship to provide value to diagnostic testing for infectious diseases in the emergency department (ED) setting. Opportunities and challenges with implementation of new ID diagnostic tests in the ED will be illustrated with use cases.

2:15 pm

Diagnostic Stewardship in Ambulatory Care and Community Pharmacy Settings

Michael E. Klepser, PharmD, FCCP, FIDP, Professor, Ferris State University College of Pharmacy

Inappropriate use of laboratory tests to guide management of individuals can lead to suboptimal patient outcomes and inappropriate use of antibiotics. Data suggests diagnostic tests, when ordered judiciously, can decrease time to receipt of appropriate antibiotics and decrease unwarranted use of antibiotics. However, indiscriminate use tests may result in excess costs and overuse of antibiotics, owing to reaction to false positive results.

2:45 pm

Point-of-Care Diagnostic Stewardship

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

John Warren, Owner and Principal Consultant, Gettysburg Healthcare Consulting, LLC

Consumers demand convenience and have grown accustomed to getting rapid testing in pharmacies and other nontraditional healthcare settings. During the pandemic, public health officials ensured that patients were tested quickly, with rapid access to treatment. Post-pandemic, payers have started to roll back some of these flexibilities. We will discuss the role of sound government policy in appropriately balancing access to, and innovation in point-of-care diagnostics.

Close of Conference3:15 pm






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