The role of advanced molecular diagnostics for infectious disease continues to grow – not only are these assays moving into the clinic, but they are being used for infection surveillance and outbreak control, appearing in the pharmacy, and continuing
to improve care in resource-limited settings. Cambridge Healthtech Institute’s 5th Annual Molecular Diagnostics for Infectious Disease conference program will feature the latest in NGS and metagenomics, the latest regulatory and reimbursement
challenges, and updates in the public health sphere. We’ll further examine the role of host response vs. pathogen detection in the clinic, the potential for microbiome analysis, and other novel approaches to infectious disease diagnosis. Special
attention will be paid to antimicrobial resistance, from the clinical challenges to the emerging technologies, and novel technologies being developed specifically for resource-limited settings. We will also address the state of the industry from the
point-of-view of numerous stakeholders: industry, regulatory, investment, technology, and clinical.
Final Agenda
Monday, March 2
10:30 Conference Program Registration Open
11:45 Organizer’s Opening Remarks
Kaitlin Searfoss Kelleher, Conference Producer, Cambridge Healthtech Institute
11:50 Chairperson’s Remarks
David Cavanaugh, Partner, DeciBio
11:55 Leading the Pack: The Strategic Revamp POC Dx Needs before Disrupting MDx
Clinical adoption and real-world use of point-of-care diagnostic (POC Dx) technologies have fallen short of their hype and promise. The field has become increasingly crowded, with hundreds of players narrowing the runway for each company to carve out
differentiated market opportunities and strategies. Disruption of the larger MDx market will require POC Dx companies to create “winning strategies” by establishing competitive differentiation from one another, driving successful adoption
and implementation, and navigating regulatory and reimbursement hurdles.
Moderator: David Cavanaugh, Partner, DeciBio
Panelists: Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories
Gyorgy Abel, MD, PhD,
Director, Molecular Diagnostics, & Clinical Chemistry/Immunology, Division of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, MA
Trevor Martin, PhD, Co-Founder and CEO, Mammoth Biosciences
Jenny Rooke, PhD, Managing Director, Genoa Ventures
Bryan Bothwell, Director, Strategy and Business Development, Qorvo Biotechnologies
Joseph San Filippo, PhD, Director, Business Development, Roche Molecular Solutions
12:55 pm Session Break
1:05 LUNCHEON PRESENTATION I: Karius Microbial Cell-free DNA for Non-invasive Identification & Prediction of Infections in Immunocompromised Patients
Tim Blauwkamp, PhD, CSO, Karius
Immunocompromised patients are vulnerable to a wide variety of infections. The Karius Test uses next-generation sequencing of microbial cell-free DNA in blood to help diagnose infections throughout the body, offering a non-invasive alternative with higher
diagnostic yield than conventional methods. We present current applications in clinical practice and describe potential future applications in predicting infections in high-risk immunocompromised patients.
1:35 LUNCHEON PRESENTATION II: Commercialization of an IVD in a Changing Global Environment
Lynn Stephenson, PhD, Marketing Manager, Dx Manufacturing & OEM, MilliporeSigma
Changes in international standards and regulations have created challenges and roadblocks to the commercialization of diagnostic devices. The choice of a contract manufacturing (CM) partner with the expertise to provide guidance and manufacturing
capabilities is one strategy diagnostics companies can use to mitigate risk. A well-chosen CM partner can accelerate the commercialization process by anticipating potential roadblocks. In this session, we will discuss best practices
and key considerations for vetting contract manufacturing partners.
2:05 Session Break
2:20 Chairperson’s Remarks
Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and Medical Director, Medical College of Wisconsin
2:25 The Promise of Culture-Free Microbiology: Are Clinical Labs Ready and Will Metagenomics Deliver on the Promise?
Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and Medical Director, Medical College of Wisconsin
Next Generation Sequencing offers the potential to interrogate clinical specimens for the presence of infectious diseases in a completely unbiased manner. However, significant challenges confront clinical microbiology laboratories attempting to implement
metagenomics using traditional clinical workflows. This presentation will discuss targeted implementation of a metagenomics assay for the detection of mycobacteria and nocardia from clinical specimens.
2:55 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 tech.
3:25 Towards Clinical Implementation of Rapid Metagenomics for the Diagnosis of Nosocomial Pneumonia
Justin O’Grady, PhD, Associate Professor, Quadram Institute Bioscience
The rise in antimicrobial resistance (AMR) is predicted to cause 10 million deaths per year by 2050 unless steps are taken to prevent this looming crisis. Microbiological culture is the gold standard for the diagnosis of bacterial/fungal pathogens
and antimicrobial resistance and takes 48 hours or longer. Hence, antibiotic prescriptions are rarely based on a definitive diagnosis and patients often receive inappropriate treatment. Rapid diagnostic tools are urgently required to guide appropriate
antimicrobial therapy, thereby improving patient outcomes and slowing the development of AMR. In this talk, I will discuss the application of rapid (~6hr) clinical metagenomics for the diagnosis of hospital-acquired and ventilator-associated pneumonia.
3:55 Advanced Serology and Immune Status Reports Powered by the Human Immunity Map
Patrick Daugherty, PhD, CSO and Founder, Serimmune, Inc.
While clinical use of antibody serology for infectious disease generally has been limited to targeted assays for just a few organisms, numerous clinical scenarios could benefit from a broad view of serological immunity. Combining high diversity
peptide display libraries, next-generation sequencing, and custom bioinformatics, we developed serum epitope repertoire analysis (SERA) to map circulating antibody specificities to their antigens and reveal one’s
immune history. Bioinformatic analysis of the resulting digital immune record enables effectively unlimited multiplexing of epitope-specific antibody assays. We analyzed the serological antibody repertoires from
more than 10,000 individuals reflecting diverse disease states including viral, bacterial, parasitic and fungal infections, autoimmunity, and cancer to build a Human Immunity Map (HIMap). We demonstrate the utility of SERA coupled with
HIMap to measure IgG and IgM serostatus for Lyme along with 50 other infectious and autoimmune markers in 1500 individuals referred for Lyme disease testing. Our results suggest that SERA has the potential to substantially increase diagnostic
yields, thereby circumventing costly and burdensome diagnostic odysseys.
4:10 COVID-19 Could Be Identified in Minutes via Mobile Technology
Paul Pickering, PhD, Chairman & CEO, Ubiquitome Limited
Fast testing during viral outbreaks, such as the coronavirus COVID-19, could assist preventing its spread. Ubiquitome will present RT-PCR data, from its proprietary Liberty16 mobile molecular detection system, covering both animal and human health.
Results are reported in real time via Ubiquitome’s iPhone app interface for dynamic outbreak response.
4:25 Refreshment Break and Transition to Plenary Keynote
4:35 Welcome Remarks
Cindy Crowninshield, RDN, LDN, HHC, Executive Event Director, Cambridge Healthtech Institute
4:45 PLENARY KEYNOTE INTRODUCTION
Thomas Westerling-Bui, PhD, Senior Scientist, Regional Business Development, Aiforia
5:00 PLENARY KEYNOTE PRESENTATION: High-Performance Medicine
Eric Topol, MD, Founder and Director, Scripps Research Translational Institute (SRTI); Author, Deep Medicine: How Artificial
Intelligence Can Make Healthcare Human Again
6:00 Grand Opening Reception in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group
7:30 End of Day
Tuesday, March 3
7:30 am Registration Open and Morning Coffee
8:00 Organizer’s Remarks
Kaitlin Searfoss Kelleher, Conference Producer, Cambridge Healthtech Institute
8:05 Chairperson’s Remarks
Tanya Gottlieb, PhD, Vice President, Scientific Affairs, MeMed
8:10 Point-of-Care Diagnostics for Antibiotic Stewardship in the Hospital and Beyond
Larissa May, MD, MSPH, MSHS, Professor and Director of ED and Outpatient Antibiotic Stewardship, Emergency Medicine, UC Davis Health
This presentation will focus on opportunities for expanding POC diagnostics for management of infectious diseases in the ED and other areas in the health system. We will demonstrate successful implementation, lessons learned, and regulatory and
practical considerations.
8:35 Geospatial “Hot Spots” in Need of Rapid Point-of-care Diagnostics for Highly Infectious Threats and Antimicrobial Resistance
Gerald Kost, MD, PhD, MS, FAACC, Director, Point-of-Care Testing Center for Teaching and Research (POCT-CTR), Emeritus Professor, School of Medicine, University of California, Davis
We will develop a framework for deploying novel point-of-care technologies that detect antimicrobial resistance. Hot spots occur across world locations no longer limited geospatially. We can integrate geoscience tools and point-of-care testing
to quickly, directly, and efficiently detect microbial and viral threats. Spatial patterns of resistance will allow us to target therapy cost-effectively.
9:00 PANEL DISCUSSION: Addressing
Antimicrobial Resistance Through Public-Private Partnerships and the NIH-BARDA
Grand Challenge
Antimicrobial resistance represents a growing public health concern, leading to BARDA and the NIH working with private companies to develop novel diagnostics. The NIH-BARDA Grand Challenge has charged participants with developing innovative and
novel rapid diagnostic tests to identify resistant bacteria or to distinguish between viral and bacterial infections to reduce over-prescription of antibiotics. Two of the five finalists will present their work and the challenges their technologies
address. We will also hear from a company collaborating directly with BARDA to advance and commercialize their assay.
Moderator: Gerald Kost, MD, PhD, MS, FAACC, Director, Point-of-Care Testing Center for Teaching and Research (POCT•CTR), Emeritus Professor, School of Medicine, University of California, Davis
Panelists: Ephraim Tsalik, MD, MHS, PhD, Founder, Predigen, Inc.
Gary Schoolnik, Director, Medical Affairs, Click Diagnostics
Timothy Sweeney, MD,
PhD, CEO, Inflammatix
9:40 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group
10:40 Improving Openness, Reproducibility and Scalability in Microbial Genomics and Bioinformatics for Public Health
Duncan MacCannell, PhD, CSO, Office of Advanced Molecular Detection, Centers for Disease Control and Prevention
Advances in sequencing technology have fundamentally changed laboratory approaches to infectious disease diagnostics, pathogen characterization, molecular epidemiology and surveillance. Operationalizing these technologies requires significant
investments in bioinformatics infrastructure and workforce. This presentation will discuss efforts to improve the openness, reproducibility and scalability of microbial genomics applications across a range of public health laboratory settings.
11:10 NEW: CO-PRESENTATION: COVID-19 Coronavirus Emergency Response Test Development Utilizing Co-Diagnostics CoPrimer TM Technology
Dwight Egan, CEO, Co Diagnostics
Masen Christsensen, Senior Design Engineer, Co Diagnostics
Our CoPrimer technology allows for rapid test development with sharp sensitivity and specificity. CoPrimers have been shown to virtually eliminate the formation of primer-dimers reducing false positives/negatives. The company’s mission
is to provide state of the art diagnostics at affordable prices to the people and nations who need them the most. We specialize in infectious diseases, Agribio & tests for mosquitos to aid in vector control. Co-Diagnostics, Inc., a
Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. The Company’s technology is utilized for tests that are designed using the detection and/or
analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests
to specific customers.
11:40 Semiconductor Biochip System for Rapid and High-multiplex Identification, Quantification, and Genotyping of Pathogens
Kirsten Johnson, PhD, Research and Development Senior Manager, InSilixa, Inc.
The emergence of pathogens resistant to antimicrobials is a growing worldwide health crisis. To curtail antimicrobial misuse, InSilixa has developed a fully integrated, miniaturized semiconductor biochip system that can rapidly identify pathogens,
quantify microbial load and determine the drug resistance profile of up to 250 sequences simultaneously. Applications developed on this platform include an upper respiratory pathogen panel, antimicrobial resistance genotyping of M. tuberculosis,
and viral load quantification and genotyping of HIV-1.
12:10 pm Session Break
1:20 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group
2:00 Breakout Discussions in the Exhibit Hall (please click here for details)
3:00 Transition to Keynote Session
3:15 Organizer’s Remarks
Christina Lingham, Executive Director, Conferences and Fellow, Cambridge Healthtech Institute
3:20 Keynote Introduction
Allison Mallory, PhD, Director, R&D Molecular Biology, Stilla Technologies
3:35 What Does the New Era of Genomic Medicine Look Like? Effects on Patient Care, Therapeutics, and Diagnostics
20 years after the completion of the first draft of the Human Genome Project, there is compelling evidence of genomics delivering the rich promise of precision medicine. There have been major advances in the throughput and affordability of
genome sequencing, enhanced tools for genome analysis and interpretation, new paradigms for therapeutics and strong signs of clinical benefit using genome editing. But major challenges remain. In this special plenary roundtable, three
established pioneers of genomic medicine – David Haussler, Stephen Kingsmore, and Liz Worthey – offer their insights on the extraordinary advances in genomic medicine over the past 1-2 decades and share their hopes and concerns
for the future of our field.
Moderator:
Kevin Davies, PhD, Executive Editor, The CRISPR Journal, Mary Ann Liebert, Inc.
Panelists: Stephen Kingsmore, MD, DSc, President/CEO, Rady Children’s Institute for Genomic Medicine
David Haussler, PhD, Investigator, Howard Hughes Medical Institute; Distinguished Professor, Biomolecular Engineering, University of California, Santa Cruz; Scientific Director, UC Santa Cruz Genomics Institute; Scientific Co-Director,
California Institute for Quantitative Biosciences (QB3)
Elizabeth Worthey, PhD, Director, Genomic Medicine, University of Alabama, Birmingham School of Medicine
4:50 Spring Fling Celebration in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group
6:00 End of Day
Wednesday, March 4
6:45 am Registration Open
7:00 BREAKFAST PANEL DISCUSSION: The Time is NOW: Creating Meaningful Change for Women in the Workplace (Sponsorship Opportunity Available)
(please see Women in Science page for details)
Moderator: Robin Toft, Author of WE CAN, The Executive Woman’s Guide to Career Advancement; Founder and Chairman, Toft Group Executive Search
Panelists: Camille Samuels, MBA, Partner, Venrock
Paul Hastings, President and CEO, Nkarta Therapeutics, Inc
Teresa L. Wright, MD, Staff Physician, Medicine, San Francisco Veterans Administration
8:00 Organizer’s Remarks
Kaitlin Searfoss Kelleher, Conference Producer, Cambridge Healthtech Institute
8:05 Chairperson’s Remarks
Jennifer Dien Bard, PhD D(ABMM), Director, Microbiology and Virology, Pathology and Laboratory Medicine, Children’s Hospital Los Angeles; University of Southern California
8:10 Machine Learning to Detect Antibiotic Resistance: Progress and Challenges
David Greenberg, MD, Associate Professor, Microbiology and Internal Medicine, University of Texas Southwestern
This talk will discuss the use of next generation sequencing approaches for predicting antibiotic resistance. It will focus on the application and development of bioinformatic pipelines to help predict resistance accurately without the need
for phenotypic testing. Examples of success as well as challenges in the field will be explored.
8:40 The Power of Bioconvergence: MeMed BV™, Using the Host Response to Distinguish between Bacterial and Viral Infections
Frederic Sweeney, PhD, Chief Business Development Officer, MeMed Diagnostics Ltd.
At the crossroad between medical evidence, biochemistry, engineering and machine learning, the MeMed team has developed a powerful platform to discover, develop, validate and commercialize new diagnostics tools. MeMed’s first test
(MeMedBV™) relied on a machine learning approach of discovery and validation of over 100,000 biomarker combinations where the best performing combination computationally integrates three circulating host proteins into a score with
>90% accuracy which has been validated in multiple double-blind international studies.
9:10 Developing an mRNA-Based Panel for Pre-Symptomatic Detection of Sepsis
Kai Wang, PhD, Principal Scientist, Institute for Systems Biology
Using longitudinal samples from patients undergoing elective surgery, we identified a blood mRNA-based panel that could diagnose sepsis 2 to 3 days prior to the onset of clinical symptoms, allowing for much earlier therapeutic intervention.
The panel was optimized using a biological function-based algorithm to reduce the number of features in the assay without affecting the performance. The diagnostic performance of the panel was validated with validation cohort.
9:40 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group
10:40 CO-PRESENTATION: From Bench to Bedside: Real-World Cases in Molecular Diagnostics for Infectious Diseases
Jennifer Dien Bard, PhD D(ABMM), Director, Microbiology and Virology, Pathology and Laboratory Medicine, Children’s Hospital Los Angeles; University of Southern California
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
Development of molecular assays has increased exponentially in the past decade and have revolutionized testing in the clinical laboratories. But how are tests being offered and reported in the laboratory? Further, how are results being interpreted
by providers? This session will provide adult and pediatric case examples of the pros and woes of molecular diagnostics for infectious diseases. An interactive discussion on current and future directions of diagnostic assays will follow.
12:10 pm Improving Influenza Outcomes Through OTC Molecular Diagnostics
Frank Myers, PhD, Director of Engineering, Lucira Health
Nearly 90% of patients with influenza do not seek medical treatment within the 48 hour window necessary for antiviral treatment. Lucira Health is developing an over-the-counter influenza diagnostic which better fits
patient relief-seeking habits at symptom onset, enabling more timely and effective access to antiviral treatment and improved flu outcomes.
12:25 Sponsored Presentation (Opportunity Available)
12:40 Session Break
12:50 Precision Health Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:20 Refreshment Break in the Exhibit Hall with Last Chance Poster Viewing, Speed Networking, Book Signing, and Meetup Group
2:00 Chairperson’s Remarks
Michael Loeffelholz, Senior Director, Medical Affairs, Cepheid
2:05 Challenges and Opportunities in Resource-Limited Settings for POC IVD Manufacturers
Michael Loeffelholz, Senior Director, Medical Affairs, Cepheid
The impact of point-of-care technologies in resource-limited settings is profound, but the development, funding, and implementation of these technologies is not always easy. There are several challenges and opportunities for POC IVD manufacturers
in resource-poor settings: technology, development, regulatory, cost considerations, to name a few. We’ll examine the industry and business perspective, as well as the clinical implementation and, most importantly, the impact
these point-of-care technologies have on patient care.
2:50 NEW: Point-of-Care Testing: Bringing the Laboratory to the Patient in Low- and Middle-Income Country Settings
Jeffrey Klausner, MD, MPH, Professor of Medicine and Public Health, David Geffen School of Medicine, University of California, Los Angeles
I will review studies across three continents demonstrating the acceptability, feasibility, and value of point-of-care diagnostic testing for sexually transmitted infections in pregnant women.
3:35 Close of Conference