Cambridge Healthtech’s 13th Annual
Enabling Point-of-Care Diagnostics
Delivering Rapid Results to Improve Outcomes
August 20-21, 2019
Point-of-care testing stands to greatly revolutionize many aspects of medicine, including providing rapid access to test results, patient access to data and the types of tests that are available. The range of diagnostic tests being imagined is growing
as are the players who can potentially manage and deliver health information to a consumer base who is hungry for it. Ensuring reliable and robust data, privacy of data and accurate results that are connected to therapeutic actions is the vision of
point-of-care testing.
Final Agenda
Scientific Advisory Board
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH
William Clarke, PhD, MBA, DABCC, Professor of Pathology, Johns Hopkins University School of Medicine
James H. Nichols, PhD, DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine
Eric Van Gieson, PhD, Program Manager, Defense Advanced Research Projects Agency (DARPA)
Recommended Short Course*
Farragut
SC1: Technologies, Applications and Commercialization of POC Dx
Holger Becker, PhD,
Founder & CSO, microfluidic ChipShop GmbH
This short course will provide an overview on the technological aspects of POC system developments. It will introduce current technologies such as microfluidics, sensors, paper- and smartphone-based approaches and discuss their trends and limitations.
The course will discuss a variety of POC systems in different stages of their development, from early stage to established diagnostic systems in the clinical routine. Market aspects of POC systems as well as practical examples of commercialization
for molecular diagnostic, immunological and clinical tests will be presented.
*Separate registration required.
TUESDAY, AUGUST 20
7:30 am Registration and Morning Coffee
8:30 Chairperson’s Opening Remarks
James H. Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology and Immunology & Medical Director, Clinical Chemistry and Point-of-Care Testing, Vanderbilt University School of Medicine
8:40 Opportunities for POCT in Modern Healthcare
James H. Nichols,
PhD, DABCC, FACB, Professor of Pathology, Microbiology and Immunology & Medical Director, Clinical Chemistry and Point-of-Care Testing, Vanderbilt University School of Medicine
Point-of-care testing is laboratory testing performed close to the site of patient care. With the advantage of rapid turnaround time and device portability, POCT is finding new applications as healthcare expands into the community. This presentation will
explore the variety of ways that POCT is being deployed and finding new avenues for delivering faster testing for improved patient management.
9:10 Environmental Effects on Point-of-Care Testing: Challenges in Mobile and Austere Settings
Nam
Tran, PhD, Associate Clinical Professor, Clinical Chemistry, Special Chemistry, Toxicology, POCT and SARC Sections, Department of Pathology and Laboratory Medicine, University of California, Davis
Environmental factors such as temperature, humidity, and altitude can impact the analytical performance of point-of-care (POC) devices. Operation of POC devices outside of established specifications may result in erroneous results. Temperature and humidity
have been shown to alter the performance of certain glucose meter test strips. Point-of-care testing operators need to be aware of device limitations in mobile and austere testing. Field-robust POC devices are needed for these unique settings.
9:40 Artificial Intelligence and Point-of-Care Diagnostics
Joel Saltz, MD, PhD,
Chair and Professor Department of Biomedical Informatics, Vice President, Clinical Informatics Stony Brook Medicine, Cherith Endowed Chair, Stony Brook University
We are employing deep learning methods synthesize patient laboratory, medication and coding information to generate nuanced clinical phenotype information. The models are trained with a combination of very large de-identified multi-institution
patient datasets and smaller institution-specific datasets. The current use of these methods is to provide support for our health system’s clinically integrated network and diabetes management efforts. We will discuss prospects of adapting
these models to optimize point-of-care test frequency as well as to optimize point-of-care diagnostics quality control.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
11:00 Options and Importance of Connectivity and Informatics in POC Testing
Bill Marquardt,
C(ASCP), MBA, CSSBB, Vice President, Lab Intelligence, McKesson Laboratory Solutions
As point-of-care testing becomes more prevalent and more tests become available, connectivity will become increasingly important to ensure quality of results (and as a result, overall quality of patient care) but to ensure costs are contained with
reimbursements being maximized. This talk will identify solutions to connectivity challenges and uncover both the obvious and hidden costs associated with remaining unconnected as well as the potential impact to patient care.
11:30 PANEL DISCUSSION
12:00 pm Optimized Lyophilization: Providing Options for You, Your Products, and Your Molecular Diagnostics Customers
Timothy Pearcy, Managing Director, BIOLYPH LLC
Lyophilization is the highest quality form of preservation, and LyoSpheres™ maximize the benefits of lyophilization. Enjoy room temperature stability, storage, and transport, more robust performance, greatly increased shelf life, superior ease
of use, limitless reagent cocktails, instant rehydration, and device flexibility for your MDx, POCT, NGS and liquid biopsy products.
12:15 Breaking Through the Sample Prep Bottleneck
Richard Spero, PhD, CEO, Redbud Labs, Inc.
Sample prep is the performance-limiting bottleneck in virtually all next-generation point-of-care diagnostics. We present an open sample-prep platform that delivers ultra-fast sample prep with benchtop quality in a cartridge-ready format.
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:00 Cookie & Refreshment Break in the Exhibit Hall with Poster Viewing
1:30 Chairperson’s Remarks
William Clarke, PhD, MBA, DABCC, Professor of Pathology, Johns Hopkins University School of Medicine
1:35 Nanopore Sequencing for Viral Diagnostics in POC Settings
Charles Chiu, MD, PhD, Professor, Departments of Laboratory Medicine and Medicine, Division of Infectious Diseases; Director, UCSF-Abbott Viral Diagnostics and Discovery Center; Associate Director, UCSF Clinical Microbiology Laboratory, UCSF
School of Medicine
Nanopore sequencing is a paradigm-shifting technology enabling real-time and comprehensive analysis of clinical samples for potential pathogens and interrogation of the host response by RNA sequencing (RNA-Seq). We will discuss current and future
applications of nanopore sequencing for diagnosis for viral infections in low-resource and POC settings.
2:05 Ensuring the Quality of Infectious Disease Point-of-Care Testing in the Urgent Care
Omai Garner, PhD, D(ABMM), Assistant Clinical Professor, Section Chief, Clinical Microbiology; Director, Point of Care Testing, UCLA Department of Pathology and Laboratory Medicine
This talk will focus on strategies and challenges in performing point-of-care tests for infectious disease in the urgent care setting. We will explore some of the most common challenges that disrupt quality in the near patient testing environment.
We will also discuss test validation, work flow analysis, and other key indicators of success for point-of-care tests.
2:35 Respiratory Pathogen Detection by NGS, Removing Barriers for Routine Application
Robert
Schlaberg, MD, MPH, Assistant Professor of Pathology, University of Utah; Medical Director, ARUP Laboratories; Co-Founder and CMO, IDbyDNA, Inc.
Universal pathogen detection tests using NGS-based metagenomics are being adopted by a growing number of diagnostic laboratories. Removing remaining barriers for adoption of this technology early in the diagnostic work-up will maximize the utility
and diagnostic yield. This presentation will summarize efforts to standardize and expedite workflows and outline a path towards potential POC solutions in the future.
3:05 A Multiplexed Platform for Point of Care Precision Medicine and Clinical Trial Enrichment
Chris Myatt, Founder, CEO, MBio Diagnostics
Heterogeneity of septic shock is a major challenge. For clinical trials, it is unclear which patients will benefit from new treatment approaches. A robust risk stratification tool has been developed to aid decision-making in the context of pediatric
sepsis. A 5-protein biomarker adaptation of the PERSEVERE risk stratification panel has been developed on the MBio point-of-care platform. The panel has been run on banked clinical samples, and comparisons with the original Luminex-based assay
are underway.
3:20 Introduction to Cyclo Olefin Polymer in Life Science Application
Larry Atupem, Senior Business Development Specialist, Zeon Specialty Materials
ZEON manufactures ZEONEX® and ZEONOR® Cyclo Olefin Polymer; an ultra-pure, inert, optically clear low-fluorescence polymer used for the construction of consumables used NGS and molecular diagnostics. The unique inherent properties ZEONEX®
and ZEONOR® Cyclo Olefin Polymer (COP) allow engineers to expand their device and detection capabilities when constructing a fully integrated consumable versus using more traditional polymers.
3:35 Refreshment Break in the Exhibit Hall with Poster Viewing
4:25 Chairperson’s Remarks
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH
4:30 An Update on the Status of CD Fluidics for Advanced Diagnostics
Marc Madou, PhD, Chancellor’s
Professor, Biomedical Engineering, University of California, Irvine
Nucleic-acid (NA) based diagnostics hold much potential, especially for the more rapid and accurate diagnosis of infectious diseases. However, nucleic acid diagnostics are still impractical to implement in many settings, requiring, to name a
few, large and expensive labs with sophisticated equipment, a well-trained staff, and many hours of labor. As a part of the shift towards de-centralized and low-cost healthcare, microfluidic platforms aim to move nucleic-acid based diagnostics
out of the laboratory and to the point-of-care (POC). This talk focuses on the research, design, and development of centrifugal microfluidic platforms as tools for nucleic acid analysis and diagnostics. In particular, novel microfluidic systems
are presented towards sample-to-answer in vitro diagnostic applications, to make nucleic acid diagnostics a reality by overcoming many of the current hurdles. Finally an overview of CD-based commercial products is given highlighting
where the field is moving to.
5:00 Accurate Diagnosis to Sepsis Using Microfluidic Assays
Daniel Irimia,
MD, PhD, Associate Professor, Surgery, Massachusetts General Hospital
Neutrophils, the first white blood cells to respond to infections, are key for understanding sepsis. However, neutrophils have short lives and new tools are required to study them as soon as blood is drawn. We have recently designed novel microfluidic
assays that advance our understanding of how neutrophils regulate their numbers at sites of infections, swarm around microbes, and return to circulation. We are leveraging these findings to design POC assays for sepsis diagnosis and monitoring.
5:30 Mobilizing Diagnostics - Overcoming the Challenges in Testing Outside the Laboratory
Nick Davala, MBA, Business Development Manager, BBI Solutions
Novarum Dx technology brings the benefit of mobile to diagnostics wherever they are deployed, ensuring patient’s access care and surveillance organizations have access to real-time statistics on disease spread. We will discuss the benefits
and demonstrate the use of a smartphone to guide users through the test workflow for a point of care test, including test timings and visual cues, before using our patented image capture software to record and analyze the test result.
6:00 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing
7:00 Close of Day
WEDNESDAY, AUGUST 21
7:15 am Registration
Independence B-E and Foyer
7:30 Problem Solving Breakout Discussions with Continental Breakfast
Challenges and Potential Solutions to POC Implementation of Sequencing Technologies
Moderator: Charles Chiu, MD, PhD, Professor, Departments of Laboratory Medicine and Medicine, Division of Infectious Diseases; Director, UCSF-Abbott Viral Diagnostics and Discovery Center; Associate Director, UCSF Clinical Microbiology Laboratory,
UCSF School of Medicine
- Challenges to routine implementation of sequencing technologies in POC settings?
- Cost, validation, and regulatory issues and potential markets
- Crowd-sourcing versus physician/scientist-driven initiatives
- Viral, bacterial, versus pan-pathogen targeting for POC infectious disease diagnostics
Informatics in POC Testing
Moderator: Bill Marquardt, C(ASCP), MBA, CSSBB, Vice President, Lab Intelligence, McKesson Laboratory Solutions
- Connectivity challenges and future of POC to D/EMR interfacing
- POC connectivity from home devices
- Artificial intelligence and autoverification of POC test results
- How more complex testing can become CLIA-Waived using more advanced informatics tools
- Using machine learning and predictive analytics within the POC laboratory
Strategies for Home and Field Deployable POCT
Moderator: Nam Tran, PhD, Associate Clinical Professor, Clinical Chemistry, Special Chemistry, Toxicology, POCT and SARC Sections, Department of Pathology and Laboratory Medicine, University of California, Davis
- Preparing for the worst: Strategies for the next disaster with field deployable POCT
- Educating home users on POCT environmental limitations
- Future of field-robust POCT devices
8:20 Chairperson’s Remarks
Eric Van Gieson, PhD, Program Manager, Defense Advanced Research Projects Agency (DARPA)
8:30 Blood Epigenetic Signatures to Predict Infection and Environmental Exposures
Stuart
Sealfon, MD, Glickenhaus Family Professor of Neurology, Icahn School of Medicine at Mount Sinai
Infection and environmental exposures may lead to persistent epigenetic changes in blood cells. Under the DARPA Epigenetic CHaracterization and Observation (ECHO) program, we are studying the use of bulk and single cell blood epigenetic assays
and machine learning approaches to predict exposure to infectious agents, specific chemicals and other perturbations, with the goal of developing a new diagnostic approach and device.
8:50 Next Generation Epigenetic POC Diagnostics
Joshua LaBaer, MD, PhD, Executive Director, The Biodesign Institute, Arizona State University
Epigenetic chromatin modifications (ECM) are heritable changes to the genome and the molecules that package it, which can alter the accessibility of DNA to regulatory proteins. Epigenetic changes can be rapid or slow, and once established, they
are stable, potentially heritable and have the potential to modify gene expression. Environmental factors like chemicals, explosives, pathogens and radioactivity can alter epigenetic regulatory features such as DNA methylation, histone modifications
and microRNA expression. Exposures to different amounts, duration and types of these agents are linked to different epigenetic modifications. With funding from DARPA, we are part of a program to develop an epigenetics signature-based point-of-care
(POC) test to identify exposures to weapons of mass destruction (WMD). WMD could be biological, radiological, chemical or explosive in nature and the epigenetic signatures could come directly from either DNA or proteins associated with DNA.
DARPA’s Epigenetic CHaracterization and Observation (ECHO) program will build a man-portable device that examines an individual’s epigenetic changes to reveal a detailed history of exposure to WMD or their precursors. Our multidisciplinary
Diagnostic EPigenetics of Infectious agents and Chemical Toxicity (DEPICT) program, will apply a comprehensive approach: a) identify both transient and long-lasting epigenetic changes by ChIPmen-Seq in blood, b) develop a microfluidic on-site
sample processing cards to enrich signature specific changes, and c) develop a POC next generation sequencing (NGS) platform to reveal WMD exposure types and time-line. We believe, in addition to providing rapid diagnosis for troops who are
exposed WMD agents, offering timely information for effective medical countermeasures, the same technology has the potential to provide a “one-size-fits-all” diagnostic tool for both chronic and infectious diseases at large.
9:10 Single-Cell Analysis for Forensic Epigenetics (SAFE)
Joseph
R. Ecker, PhD, Professor and Salk International Council Chair in Genetics, Howard Hughes Medical Institute Investigator, The Salk Institute for Biological Studies
The goal of this research is to define temporal changes in the features of an individual’s epigenome to determine their history of environmental exposures. In SAFE, we are applying state-of-the-art single-cell epigenomic analyses of
blood samples to identify signatures of exposure. Biomarker discovery from single nuclei avoids losing strong epigenetic signals from rare cells in the dynamic epigenetic background noise, allowing identification of low-abundance features
that can be correlated with exposure.
9:30 A New Nanopore Approach to Rapid Readout of DNA Epigenetic Modifications
Bharath Takulapalli, PhD, Founder & CEO, INanoBio, Inc.
Information encoded in the epigenome is linear from one end to the other, encoded in epigenetic markers on DNA, nucleosomal histones and the DNA sequence. The simplest way to read this linear information chain is to probe it at a single point
along the chain using nanopore technology, from end to end. INanoBio is developing an advanced nanopore-transistor device for rapid readout the epigenome, at the point of need.
9:50 Q&A
10:00 The Future of Near Patient Testing
Bryan
Bothwell, Director, Strategy and Business Development, Qorvo Biotechnologies, LLC
Qorvo Biotechnologies biosensor platform creates a paradigm shift in point of need testing. Bulk acoustic wave detection arrays combined with microfluidics and electronics integration enables centralized lab results at the true point of need-
breaking technological barriers limiting ubiquitous deployment.
10:30 Coffee Break in the Exhibit Hall with Poster Viewing
Constitution A&B
11:30 Plenary Keynote Session
11:30 Chairperson’s Remarks
Charles Mathews, Principal, ClearView Healthcare Partners
11:40 NEW: Plenary Keynote Presentation: FDA Updates: Now and Looking to the Future
Katherine Donigan, PhD, Acting Director of Personalized Medicine, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration
Introduction and background of the new Office Director of OIR and updates on precision medicine and other initiatives at the FDA.
12:10-1:05 pm Plenary Keynote Discussion: Proposals and Solutions for Diagnostic Reform Including Oversight of Laboratory Developed Tests (LDTs)
Moderator:
Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition
- How are stakeholders influencing congressional activity on the Verifying Accurate Leading-edge IVCT Development (VALID) Act?
- How will the VALID Act change the current oversight landscape for diagnostics, including LDTs?
- How are policymakers addressing the role of CMS and CLIA in the VALID Act?
- How will increased regulatory and oversight activities at the FDA affect the diagnostics industry?
- What impact will changes in diagnostics regulation and oversight have on patient care?
Panelists:
Julie Khani, MPA, President, American Clinical Laboratory Association (ACLA)
Donald E. Horton, Jr., Senior Vice President, Global Government Relations & Public Policy, Laboratory Corporation of America Holdings
Susan Van Meter, Executive Director, AdvaMedDx
Tara Burke, PhD,
Senior Director, Public Policy & Advocacy, Association for Molecular Pathology (AMP)
Laura Lasiter, PhD, Science Policy Analyst, Friends of Cancer Research
1:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:35 Close of Enabling Point-of-Care Diagnostics
Recommended Short Course*
SC15: Microfluidics and Lab-on-a-Chip Devices for POCT: Technologies and Commercialization
Chris
Myatt, Founder & CEO, MBio Diagnostics, Inc.
Additional Speakers to be Announced
This short course will provide an overview of microfluidic techniques, including valved and valve-less devices, pumped systems, and capillary flow approaches. Practical examples will keep the discussion grounded in the realization of commercializable
devices. We will discuss engineering approaches to enhance the advantages and minimize the challenges. Throughout, the science will be linked to the commercial case for these devices, including a full discussion of a recent success
story of a centrifugal microfluidic molecular assay system.
*Separate registration required.