2020 Archived Content

Cambridge Healthtech Institute’s 2nd Annual

Point-of-Care Technologies

Exploring Microfluidics, Sensors & Digital Tools

August 26 - 27, 2020 ALL TIMES EDT

Point-of-care technologies (POCT) provide actionable information at the location and time of care. This can mean by the hospital bedside, on the battlefield, or even at home versus conventional laboratory-based testing. This requires diagnostic testing to be done in a way where sample preparation is automated, the assay or sensor is accurate with a simple read out, having the whole platform should be easy to bring to locations outside of a laboratory or a hospital, and the cost to manufacture should be low. Some POC tests can utilize a smart phone or other mobile device to provide data analysis and is useful for sending data to the cloud. Creating an accurate, sensitive, reliable diagnostics that anyone can use is difficult, and there are many challenges to overcome. The Point-of-Care Technologies program, part of the Next Generation Diagnostics Summit, will discuss improvements and innovations that have been made to provide the most actionable information when and where the patient is located.

Wednesday, August 26

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

12:15 pmKeynote Introduction

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

1:00 pmThe Critical Role of Antigens and Antibodies in SARS-CoV-2 Serological Test Development

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.

1:30 pm The Next Generation of Continuous Diagnostic Sensors: A Case Study on the Breakthroughs for Sweat Biosensing

Jason Heikenfeld, PhD, Associate Vice President, Operations, Office of Innovation; Professor and Director, Novel Device Laboratory, University of Cincinnati

Continuous biosensing promises to bring the lab into a wearable format that measures anything from cardiac health to pre-symptomatic viral detection. The reality of this promise is that success continues to be limited to glucose monitoring or conventional, decades-old optical or electrical non-specific measures. We present the real challenges the field faces, along with first-ever breakthroughs that have resulted in non-invasive wearables that can provide continuous blood-correlated chemical data. Our case study is sweat biosensing, but learnings apply to all other forms of biofluid access (saliva, tears, urine, interstial fluid).

1:50 pm Developing Next-Generation Diagnostics to Meet Clinical Needs

Ping Wang, PhD, DABCC, FAACC, Professor, Pathology and Laboratory Medicine, University of Pennsylvania; Chief, Clinical Chemistry, Hospital of University of Pennsylvania

The field of point-of-care technologies has witnessed strong growth, as evidenced by new clinical or consumer products or research and development directions. Only when combined with appropriate strategies for clinical needs assessment, validation and implementation, these technologies may significantly impact care delivery and associated outcomes and costs. In this presentation, I will discuss clinical needs, validation and implementation strategies for novel point-of-care technologies from two perspectives: as a practicing clinical laboratory director and as a technology researcher and developer.

2:10 pm Session Break - View Our Virtual Exhibit Hall

2:35 pm LIVE Q&A:

Session Wrap-Up

Panel Moderator:

Shawn Mulvaney, PhD, Section Head, Surface Nanoscience and Sensor Technology Section, Chemistry, U.S. Naval Research Laboratory

Panelists:

Ping Wang, PhD, DABCC, FAACC, Professor, Pathology and Laboratory Medicine, University of Pennsylvania; Chief, Clinical Chemistry, Hospital of University of Pennsylvania

Jason Heikenfeld, PhD, Associate Vice President, Operations, Office of Innovation; Professor and Director, Novel Device Laboratory, University of Cincinnati

2:55 pm Refresh Break - View our Virtual Exhibit Hall

3:35 pm KEYNOTE PRESENTATION: Engineering Biology for Diagnostic Solutions

William Blake, PhD, CTO, Sherlock Biosciences

SHERLOCK is a method for single molecule detection of nucleic acid targets and stands for Specific High Sensitivity Enzymatic Reporter unLOCKing. It works by amplifying genetic sequences and programming a CRISPR molecule to detect the presence of a specific genetic signature in a sample, which can also be quantified. When it finds those signatures, the CRISPR enzyme is activated and releases a robust signal. This signal can be adapted to work on a simple paper strip test, in laboratory equipment, or to provide an electrochemical readout that can be read with a mobile phone.

3:55 pm Instrument-Free Paper-Based POC Pathogen Diagnostics for the Clinic and the Home

Paul Yager, PhD, Professor, Department of Bioengineering, University of Washington

Instruments ranging from the venerable GeneXpert to ones just coming on the market allow fairly rapid NAAT pathogen detection, but they are based on disposable cartridges and a permanent (and relatively expensive) instrument. Our lab has been developing instrument-free disposable NAAT devices that retain the advantages of the instrumented systems, but free the user from the need for purchasing a permanent instrument (and the upfront cost that incurs).

4:15 pm LIVE Q&A:

Session Wrap-Up

Panel Moderator:

Shawn Mulvaney, PhD, Section Head, Surface Nanoscience and Sensor Technology Section, Chemistry, U.S. Naval Research Laboratory

Panelists:

William Blake, PhD, CTO, Sherlock Biosciences

Paul Yager, PhD, Professor, Department of Bioengineering, University of Washington

4:35 pm Happy Hour - View our Virtual Exhibit Hall

5:10 pm Close of Day

Thursday, August 27

9:05 am Fast, Accurate, and Actionable: How Digital Tools in Femtech Unlock a $50 Billion Market

Danielle Bradnan, MS, Research Associate, Digital Health and Wellness, Lux Research

Current diagnostic paradigms often leave women’s health as a secondary or niche consideration, which has led to considerable struggles for over half of the global population in terms of getting a rapid, accurate, and actionable diagnosis. However, with the advent of digital tools such as apps, wearables, and AI, healthcare startups are rapidly developing solutions to close the gap between symptoms and diagnosis. We will explore the current solution landscape in this talk and highlight the opportunities that diagnostic tools offer.

9:25 am Advancing Care with Digital Therapeutics

Sharief Taraman, MD, CMO, Cognoa; Division Chief, CHOC Children’s Hospital

Early intervention of autism is proven to impact a child’s lifelong outcomes, but today’s system misses the critical window when treatment has its greatest impact. This session explains how a clinically validated, AI-powered prescription diagnostic, designed for use by pediatricians, can streamline and scale early diagnosis and fast-track access to care. Audiences will understand how digital therapeutics can enable equitable health outcomes for children with behavioral health conditions.

9:45 am LIVE Q&A:

Session Wrap Up

Panel Moderator:

Sharief Taraman, MD, CMO, Cognoa; Division Chief, CHOC Children’s Hospital

Panelist:

Danielle Bradnan, MS, Research Associate, Digital Health and Wellness, Lux Research

10:05 am Coffee Break - View Our Virtual Exhibit Hall

10:15 am Problem Solving Discussions - View Our Virtual Exhibit Hall

BREAKOUT 10: How AI-Based Devices can Better Inform Clinical Decision-Making

Sharief Taraman, MD, CMO, Cognoa; Division Chief, CHOC Children’s Hospital

Digital technologies can address healthcare disparities for more equitable outcomes and become first-line-of care, solving the access challenge
Digital devices have safety/low-risk advantages over drugs and can enable combination therapies that are more effective

10:45 am

Chairperson's Remarks

Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH

10:50 am Novel Techniques for POC Disease Monitoring Utilizing Programmable Molecular Velcro

Kaylyn Oshaben, PhD, Synthetic Biology Specialist, Altratech Limited

Altratech is interested in moving disease monitoring to the point-of-care and beyond. Common barriers to implementing point-of-care or home nucleic acid disease monitoring systems revolve around sample prep, reagent storage and user expertise. To overcome some of these barriers, we are developing new techniques that utilize peptide nucleic acids (PNA) as both enrichment and capture agents that simplify sample prep, reagents and detection technology.

11:10 am Application of Intelligent Quality Management at Point-of-Care

Sohrab Mansouri, PhD, Staff Scientist, Advance Development, Instrumentation Laboratory

This presentation describes an integrated QC method based on identifying error patterns for a given measurement system and devising a method for rapid detection and targeted corrective action with no user involvement.

11:30 am Session Break

11:40 am LIVE Q&A:

Session Wrap Up

Panel Moderator:

Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH

Panelists:

Sohrab Mansouri, PhD, Staff Scientist, Advance Development, Instrumentation Laboratory

Kaylyn Oshaben, PhD, Synthetic Biology Specialist, Altratech Limited

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

12:30 pm

eRAPID Technology – A Universal Multiplexed Electrochemical Sensor Platform Repurposed to Detect COVID-19 Antibodies

Pawan Jolly, PhD, Senior Scientist, Wyss Institute, Harvard University

eRapid is electrical sensor technology, enabling the detection of small chemicals and large biomolecules in complex fluid samples, including blood, saliva, and urine without requiring sample preparation. This proprietary sensor technology offers a versatile, multiplexed, cost-effective, robust, manufacturable, and scalable approach adaptable to a variety of testing strategies addressing high-value challenges in multiple fields, ranging from home healthcare to industrial, environmental, and food applications.

12:50 pm CASE STUDY: Federal Resources for Early-Stage Diagnostic Start-Up

Tiffani Lash, PhD, Program Director, National Institutes of Health

I will discuss the federal resources for early-stage companies that fall into the research portfolios of biosensors, platform technologies, and mHealth programs at NIH. NIBIB Point-of-Care Technologies Research Network will be explained, consisting of three centers charged with developing point-of-care diagnostic technologies through collaborative efforts that merge scientific and technological capabilities with clinical need.

1:10 pm PANEL DISCUSSION: Commercializing Point-of-Care Tests – Translating Early-Stage Innovation

Panel Moderator:

Richard Chasen Spero, PhD, CEO, Redbud Labs, Inc.

Current status on bringing your technology to market
Key considerations for developing an early translational roadmap
Funding opportunities and business plan requirements
How do you develop your go-to-market strategy?
Attracting early strategic partners
What role are KOLs and/or institutions playing as you bring your technology to market?

Panelists:

Pawan Jolly, PhD, Senior Scientist, Wyss Institute, Harvard University

Tiffani Lash, PhD, Program Director, National Institutes of Health

1:20 pm Close of Summit