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Cambridge Healthtech Institute’s 7th Annual

Infectious Disease Diagnostics

Emerging Technologies in the Post-Pandemic Era

February 22-23, 2022


The COVID-19 pandemic has fueled explosive innovation and investment in advanced technologies for infectious disease diagnostics. Cambridge Healthtech Institute’s 7th Annual Infectious Disease Diagnostics conference will span applications in the clinic, community surveillance, pharmacies, resource-limited settings, and at-home diagnostics. Technology innovations include rapid COVID-19 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.

Tuesday, February 22



1:00 pm

Chairperson's Remarks

Lisa M. Suennen, Lead/Senior Managing Director, Digital & Technology Group, Manatt Phelps & Phillips LLP
Anne Wyllie, PhD, SalivaDirect Principal Investigator, Research Scientist, Epidemiology of Microbial Diseases, Yale School of Public Health
1:15 pm

Innovating Diagnostics to End a Pandemic: The RADx Tech Experience

Steven Schachter, MD, Professor, Neurology, Harvard Medical School; Chief Academic Officer and RADx Chief, CIMIT

Rapid Acceleration of Diagnostics (RADx) Tech is an NIH-funded program launched on April 29, 2020, to accelerate development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can directly detect the virus that causes COVID-19 and its variants. After 15 months, the program generated 27 FDA Emergency Use Authorizations for COVID-19 diagnostic tests, including the first over-the-counter test for use at home without a prescription, and produced 500 million tests. RADx Tech has proven to be a model of academic-industry-government collaboration for translational medtech development.

1:45 pm

Innovative Tests for COVID-19, Future Pandemics, and Potential Use in Non-Pandemic Test Development

Timothy Stenzel, MD, PhD, Director, Office of in vitro Diagnostics and Radiological Health, FDA

Investing in Precision Medicine: Trends in Diagnostics, HealthTech and Digital Health

Panel Moderator:
Lisa M. Suennen, Lead/Senior Managing Director, Digital & Technology Group, Manatt Phelps & Phillips LLP

Precision Medicine is driven by the innovation continuum spanning genomics and diagnostics, MedTech and HealthTech, AI and Digital Health. The panel will explore investment opportunities and growth trends in the post-pandemic era, as well as the impact of precision medicine innovation on improving health outcomes and patient experience, managing healthcare costs, and advancing health equity.

Tom Miller, Founder & Managing Partner, GreyBird Ventures, LLC
Mara G. Aspinall, Managing Director, BlueStone Venture Partners, LLC
Jenny Rooke, PhD, Managing Director, Genoa Ventures
Taha Jangda, Partner, HealthX Ventures
Michele Colucci, Founder & Managing Partner, DigitalDx Ventures
2:45 pm Refreshment Break in the Exhibit Hall with Poster Viewing (Indigo BFGCDH)



3:30 pm

SARS-CoV-2 Testing: The University of Washington Medical Center Experience

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

This talk will cover the rapidly evolving area of SARS-CoV-2 diagnostics from 2020-2022, highlighting recent trends, as well as our experience with central lab and distributed testing.

4:00 pm

SARS-CoV-2 Molecular Testing: From LDT to Variants Testing at a Cancer Hospital

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

This presentation will discuss the evolution of molecular diagnostics for SARS-CoV-2 testing at a cancer hospital from the beginning of the pandemic to current state including development and implementation of laboratory-developed tests to SARS-CoV-2 variant testing.

Cliff Ramsdell, Science & Technology Advisor, 10x Genomics

The ongoing coronavirus (COVID-19) outbreak has taken thousands of lives, and the number of infections is growing daily. In this webinar we will discuss the utility of single cell technologies to advance infectious disease research, highlighting how the scientific community can respond to such events.

Erik Crawford, Strategic Partnerships Manager, imec

Imec has developed a SARS-CoV-2 test that combines an ‘easy’ breath sample and a sensitive PCR analysis on chip (<15min). The silicon chip at the core combines efficient aerosol collection and low impedance to air flow so a sample can be collected with a 1-minute breath. This platform demonstrated in SARS-CoV-2 will unlock the potential of breath specimens for diagnostics, novel biomarkers, and research in pandemic management and in other indications.


5:00 pm

COVID-19 and Beyond: Navigating Testing in a Dynamic Respiratory Environment

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

As the COVID-19 pandemic has progressed and common respiratory infections have re-emerged, the need to simultaneously test for multiple pathogens is more apparent than ever. This has been compounded by the fact that there is no way to definitively diagnose COVID-19 versus other common respiratory illnesses based on clinical symptomology. The aim of this presentation will be to review SARS-CoV-2 and COVID-19 clinical symptomology in relation to other common respiratory viruses, to better understand the testing needs for SARS-CoV-2 and traditional respiratory pathogens, and to review work done on multiplex respiratory pathogen identification.

5:30 pm

Use Case Scenarios for the Selection of Molecular Methods for Point-of-Care Testing: How the SARS-CoV-2 Pandemic Taught Us New Best Practices

Jeanne Mumford, MT(ASCP), Manager, Point-of-Care Testing, Johns Hopkins Hospital

In this session we’ll review several use case scenarios that cover inpatient, outpatient, and employee testing locations. We will outline each of the testing options that were available, what factors affected the decision process, and how to narrow down the best test for each. Selecting molecular point-of-care tests in the last 20 months was sometimes strongly dependent on the global supply chain and manufacturing limitations and learning how to overcome those challenges. Lastly, we’ll conclude with a brief overview of the best practices that were identified through the course of this pandemic and how they may influence future decisions for selecting molecular POCT.

6:00 pm

The “New Normal” in COVID-19 Testing

Mark J. Lee, PhD, Assistant Professor & Assistant Director, DUHS Clinical Microbiology Labs, Duke University

From the first SARS-CoV-2 assays to genotyping, the demand for testing has put considerable burden on clinical laboratories. Laboratories are faced with juggling pre-op screening, symptomatic and asymptomatic testing, viral load estimation, and more recently, genotyping to meet the demands of the “New Normal” in COVID-19 testing. This juggling act hinges on diagnostic stewardship, regulatory compliance, logistics, and various technical constraints. This presentation will focus on how one academic institution is navigating through this “New Normal” in COVID-19 testing.

6:30 pm Close of Day

Wednesday, February 23

7:30 am Registration Open and Morning Coffee (Indigo West Foyer AB)



8:05 am

Chairperson's Remarks

Edward Abrahams, PhD, President, Personalized Medicine Coalition
8:10 am

Personalized Healthcare in Big Pharma: A 2022 Perspective

Jeffrey Venstrom, MD, Chief Medical Partner, US Medical Affairs, Genentech

Realizing the promises of PHC can deliver improved outcomes for patients at a lower cost to them and to society. At Genentech, we believe the key to rapidly deploying personalized solutions and delivering optimal outcomes for patients faster is through strategic partnerships from a range of different sectors and disciplines across the healthcare system, collaborating and innovating together.

8:40 am

Increasing Access to Precision Medicine – The Next-Generation of Companion Diagnostics

Ruth E. March, PhD, Senior Vice President & Head, Precision Medicine & Biosamples, AstraZeneca

Precision medicine uses diagnostic tests to match the right drugs to patients most likely to respond. As science advances through the use of advanced analytics, artificial intelligence and integrated sources of biomarker data, we need a new generation of diagnostic tests. Following the patient journey in different treatment settings offers opportunities to all patients to be able to gain access to appropriate diagnostic solutions.


Implementing Precision Medicine at Big Pharma

Panel Moderator:
Edward Abrahams, PhD, President, Personalized Medicine Coalition

Over the past decade, precision medicine promised to impact drug development by targeting the right medicine to the right patient. The panel of pharma thought leaders will discuss strategies to implement precision medicine in the drug discovery and development pipeline, including biomarker and companion diagnostic development, patient stratification, precision oncology advances, and emerging molecular tools for disease characterization.

Jeffrey Venstrom, MD, Chief Medical Partner, US Medical Affairs, Genentech
Maria C. M. Orr, PhD, FRSB, Head of Precision Medicine, Biopharmaceuticals, AstraZeneca
Marielena Mata, PhD, Senior Director and Diagnostic Lead, Oncology Program, Pfizer Inc.
Christopher Conn, PhD, Director, Companion Diagnostics, AbbVie
Andrea L. Stevens, PhD, Director, Precision Medicine Access Strategy, Janssen Pharmaceuticals, Inc.
9:40 am Coffee Break in the Exhibit Hall with Poster Viewing (Indigo BFGCDH)



10:20 am

Chairperson's Remarks

Michael J. Mina, MD, PhD, CSO, eMed
10:25 am

Nanopore Sequencing as an Alternative to Microarray Detection of Pathogens in Blood

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

The large number of infectious agents in blood and the continually emerging agents are a constant challenge for diagnostic and blood donor screening devices. To increase sensitivity, multiplicity and speed sample to answer, new technologies must be designed and tested. We have tested the OpenArray spatially multiplex platform, the resequencing microarray, and are now applying the Oxford Nanopore MinION next-generation sequencer to high specificity identification of pathogens in blood.

10:55 am

Update on COVID-19 Diagnostics

Michael J. Mina, MD, PhD, CSO, eMed
11:25 am

Tracking Emerging Viruses and Microbes in Sewers and Spacecraft

Christopher Mason, PhD, Associate Professor, Physiology and Biophysics; Co-Director, WorldQuant Initiative for Quantitative Prediction, Weill Cornell Medicine

The avalanche of easy-to-create genomics data has impacted almost all areas of medicine and science, from cancer patients and microbial diagnostics to molecular monitoring for astronauts in space. In this seminar, new discoveries from RNA- and DNA-sequencing across dozens of cities on Earth will be detailed, including the analysis of wastewater as a means to track SARS-CoV-2 levels, and also explore the investigation of new species found on the International Space Station. Recent technologies and algorithms from our laboratory and others demonstrate that an integrative, cross-kingdom view of patients (precision metagenomics) holds unprecedented biomedical potential to discern risk, improve diagnostic accuracy, and to map both genetic and epigenetic states around the world and in real-time. Finally, these methods and molecular tools work together to guide comprehensive, longitudinal, multi-omic views of human astronaut physiology in the NASA Twins Study, which lay the foundation for future long-duration spaceflight, including sequencing, quantifying, and engineering genomes to survive on other planets over the next 500 years.

Glen Hansen, PhD, Medical Director, Clinical Microbiology and Molecular Diagnostics, Hennepin County Medical Center

Laboratory diagnosis has never been more visible to patients, the public, and healthcare than it currently is. This talk focuses on contemporary lessons, and challenges in the continued diagnostic scene, including the application of diagnostics on new COVID-19 therapies, the impact of rapid PCR as a supplement to public health sequencing efforts, and the need for multiplex assays to address upcoming challenges posed by "twindemic" viruses (COVID-19 & RSV). 

12:25 pm Session Break
Kerry Trice, Molecular Diagnostics Application Specialist, MilliporeSigma

From molecular diagnostics based on PCR and next generation sequencing (NGS), to those incorporating CRISPR, strategies used in the design of in vitro diagnostic (IVD) assays increasingly take advantage of disruptive technologies at the forefront of innovation. This presentation will review unique technologies used in diagnostics testing, provide insight into case studies on the development of assays with diagnostic customers, and end with an overview of custom manufacturing capabilities at MilliporeSigma.


1:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:30 pm Refreshment Break in the Exhibit Hall with Last Chance Poster Viewing (Indigo BFGCDH)


2:00 pm

Chairperson's Remarks

Christopher W. Woods, MD, MPH, Professor, Medicine, Global Health & Pathology, Duke University
2:05 pm

Development of COVID Variant Agnostic and Lineage Defining Assays

Eric H. Lai, PhD, Managing Executive, Personalized Science LLC; Team Lead, RADx Initiative

SARS-Cov-2 first appeared in December 2019 in Wuhan China and many Variants of Concern (VOC), like the highly transmissible Delta variant, pose a serious threat to global public health. A large number of efforts have been spent on the monitoring of VOC and to assess the clinical performance of diagnostic assays. In May 2020, NIH launched the Rapid Acceleration of Diagnostics (RADx) initiative to speed development of COVID-19 testing and to increase testing capability. In this session, I will review RADx activities related to development of variant agnostic assays and new approaches for the rapid surveillance of COVID-19 variants.

2:35 pm

Identifying SARS-CoV-2 Mutations: A Multiplexed Microarray for Rapid COVID-19 Detection and Variant Identification

Candy M. Rivas, PhD, Principal Scientist, PathogenDx

Viral variants have emerged with resistance to the current vaccines targeting coronavirus disease 2019 (Covid-19). The increased transmissibility or virulence is hindering public health measures. Therefore, it is imperative that rapid, low-cost diagnostics are available with the ability to diagnose and identify variants. In this presentation, we describe our low-cost DNA microarray that has the ability to diagnose, identify variants present in the population, and rapidly adapt to novel mutations.

3:05 pm

Lessons Learned from SARS-CoV-2 Sequencing Efforts in Northern New England

Joel Lefferts, PhD, HCLD, DABCC, Associate Professor of Pathology & Laboratory Medicine; Assistant Director, Clinical Genomics and Advanced Technology (CGAT), Department of Pathology and Laboratory Medicine, Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center

SARS-CoV-2 viral genome sequencing has been a valuable tool for the clinical diagnostics, infection prevention, public health, and epidemiologic communities since the start of the pandemic. The value of SARS-CoV-2 sequencing data continues through waves of increasing and decreasing case prevalence. Viral sequencing in northern New England was helped through collaborative efforts between departments and institutions. Similar collaborative models could be a useful approach for to bring together clinical specimens, patient data and a variety of skills to provide important biomedical information.


3:35 pm Interactive Discussions (In-person only)

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated to promote social distancing. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussion page on the conference website for a complete listing of topics and descriptions.

4:05 pm Session Break


4:15 pm

Point-of-Need Host Gene Expression Testing

Ephraim Tsalik, MD, MHS, PhD, Associate Professor, Medicine, Center for Applied Genomics & Precision Medicine, Duke University

Biomeme, an emerging leader in portable molecular diagnostics and infectious disease testing solutions, has developed a first-of-its-kind quantitative real-time PCR platform to measure host response tests for pre-symptomatic detection of viral infections and accurate discrimination of viral from bacterial infections at the point-of-need. This test solution will inform appropriate use of antibiotics and more generally, empower clinicians to deliver precision medicine solutions for other infectious and inflammatory diseases.

4:45 pm

Harnessing the Host Response for Diagnosis and Prognosis of COVID-19

Micah McClain, MD, PhD, Associate Professor, Medicine, Duke University School of Medicine

The pandemic has provided a watershed moment for new diagnostics for respiratory viral infections. The vast majority of new approaches focus on pathogen detection whether at the hospital, the clinic, or in the home but have limitations. Respiratory or whole blood host response signatures using diverse analytes (mRNA, cytokines, DNA methylation) show promise for augmenting diagnostic and prognostic accuracy.

5:15 pm

High-Precision, High-Sensitivity Molecular Diagnostics for Point-of-Use Applications

Paul W. Bohn, PhD, Arthur J. Schmitt Professor, Chemical & Biomolecular Engineering, University of Notre Dame

We describe a label-free electrochemical immunosensor for interleukin- in human cerebrospinal fluid (CSF) and serum, capable of quantitation in the range 1 pg mL-1 - 1 µg mL-1. The sensor can deliver rapid results (~ 3 min) for traumatic brain injury and potentially also address an unmet need for diagnostics for other cytokine-related illnesses, such as sepsis and COVID-19 induced cytokine storms.

5:45 pm Close of Conference

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