Cambridge Healthtech Institute’s Twelfth Annual
Enabling Point-of-Care Diagnostics
Delivering Rapid Results to Improve Outcomes
August 20-21, 2018 | Grand Hyatt Washington | Washington, DC
The demand for point-of-care testing is growing worldwide and is projected to be a $36 billion industry by 2021 due to the increased need for testing in emergency management, AMR and infectious disease outbreaks. The unmet medical need for rapid testing
is increasing; in the field of cancer, matching patients with the appropriate immunotherapy regimen would both improve patient results and decrease adverse events. Detecting circulating tumor cells and cell-free DNA would benefit greatly if a
rapid POC test were available. The computing power and omnipresence of cell phones combined with the need for rapid results is fueling a wave of point-of-care, wearable and handheld testing development and implementation. Ensuring quality, overcoming
technical hurdles in platform development and integrating into the clinical and lab work flow need to be established to make sure this industry continues to drive cost reduction and improvements in patient care around the globe.
Final Agenda
Recommended Short Course*
SC4: Technologies, Applications and Commercialization of Point-of-Care Diagnostics
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH
*Separate registration required
Scientific Advisory Board
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH
James H. Nichols, PhD, DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine
Gerald J. Kost, MD, MS, PhD, Director, Point-of-Care Testing Center for Teaching and Research (POCT•CTR); Emeritus Professor, Pathology and Laboratory Medicine, School of Medicine, University of California, Davis
MONDAY, AUGUST 20
12:00 pm Main Conference Registration (Independence Foyer)
1:30 Chairperson’s Opening Remarks
Gerald J. 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
1:40 Implementing Point-of-Care Testing to Improve Outcomes
Kent Lewandrowski, MD, Associate Chief of Pathology, Director, Pathology Laboratories and Molecular
Medicine, Massachusetts General Hospital; Professor, Pathology, Harvard Medical School
Many devices have been developed that permit a wide menu of tests to be performed at the point of care (POC). Typically, POC tests are more expensive on a unit cost basis than testing performed in a centralized laboratory. It is therefore important
to demonstrate an improvement in outcomes when implementing POC testing. This presentation will review cases from the literature that demonstrated improved outcomes resulting from POC testing in hospital and outpatient settings.
2:10 Point-of-Care Molecular Diagnostics for Ebola, Zika, and Other Highly Infectious Diseases—Have We Arrived or Just Begun?
Gerald J. 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
Outbreaks and natural disasters impact national economies adversely and devastate limited resource countries. Ebola demonstrated unequivocally the need for point-of-care testing in isolation laboratories and field sites. Our goal is to assess whether
molecular diagnostics are adequate to rapidly detect and stop highly infectious threats in the US and abroad. Novel POC technologies and international leadership enhance responses to community epidemics and global pandemics, but are we ready for
this uncertain future?
2:40 Human Centric Design Considerations for Developing Point-of-Care Diagnostics
Herbert S. Bresler, PhD, Senior Research Leader, Health Business Unit, Battelle
Human Centric Design (HCD) for medical devices and diagnostics is inseparable from good product design, generally. Considering the needs of users, their workflow, the environment and even the purchasers, are all essential to the success of a medical
device. HCD is even more important for devices and diagnostics used at the point of care, which implies operation by non-laboratory staff outside the traditional clinical diagnostic setting. In these use scenarios, it is vitally important that
HCD considerations accommodate the limits of the both the users and the technology to achieve a successful outcome.
3:10 Improving the Performance and Connectivity of Lateral Flow Assays for Diagnostic Applications
David Fraser, MBA, Product Manager - Lateral Flow and Detection, Product & Marketing, BBI Group
Neil Polwart, PhD, BBI Group Head, Mobile, Commercial, Novarum DX
Lateral flow immunoassays (LFI) are commonly used for many point-of-care (POC) and diagnostic applications. A novel conjugation blocking service, Morffi™ signal enhancement technology, has been shown to improve LFI test line intensity and
assay limit of detection. Rate of appearance of the test line is also improved and the interpretation and subsequent sharing of test results are supported from the POC by next-generation smartphone-enabled diagnostic readers developed by Novarum
DX.
3:40 Networking Coffee Break (Independence Foyer)
4:15 pm Chairperson’s Remarks
Charles Mathews, Principal, ClearView Healthcare Partners
4:25 - 5:45 pm Global Dx Insights: Policy and Prediction for Diagnostics
Moderator: Cecilia Schott, PhD, Former Vice President, Precision Medicine, AstraZeneca
- Will value-based medicine replace fee-for-service?
- PAMA impact on reimbursement
- Changes in LDT oversight policy
- Changing landscape of IVD regulation in U.K. and Europe after Brexit
- What is the future of molecular diagnostics in medical care?
- How will these policy changes affect the patient?
Panelists:
Dennis J. Dietzen, PhD, DABCC, FAACC, President, AACC; Professor of Pathology & Immunology and Pediatrics, Washington University School of Medicine; Medical Director of Laboratory Services, St. Louis Children’s Hospital
John Leite, PhD, Vice President, Strategic Partnerships, Corporate and Business Development, Illumina
J. Leonard Lichtenfeld, MD, MACP, Deputy CMO, American Cancer Society, Inc.
Victoria M. Pratt, PhD, FACMG, Director, Pharmacogenomics and Molecular Genetics Laboratories, Department of Medical and Molecular Genetics, Indiana University School of Medicine (AMP President-Elect)
Susan Van Meter, Executive Director, AdvaMedDx
Ian S. Young, MD, PhD, Chief Scientific Advisor, Department of Health (Northern Ireland) and President, Association for Clinical Biochemistry and Laboratory Medicine (ACB), UK
5:45 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing (Independence Ballroom)
7:00 Close of Day
TUESDAY, AUGUST 21
7:15 am Registration (Independence Foyer)
7:30 Problem Solving Breakout Sessions with Continental Breakfast (Independence F-I)
Molecular Diagnostics and Detection of Rare Mutant Alleles at the Point of Care
Haim H. Bau, PhD, Professor, Mechanical Engineering and Applied Mechanics, University of Pennsylvania
- Molecular diagnostics at the point of care
- Detection of mutant alleles at the point of care
Evidence Review and Development for Advanced Diagnostics
Joseph Chin, MD, Deputy Director, Coverage & Analysis Group, US Dept of Health & Human Services, Centers for Medicare & Medicaid Services
- Framework for evidence review
- Translation and implementation science
- Clinical study networks to develop evidence
Challenges for Point-of-Care Blood Collection: Managing Quality in the Real-World
James H. Nichols, PhD, DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry and POCT, Vanderbilt University School of Medicine
- Describe current challenges with phlebotomy and transfer of blood to POCT devices
- Recognize inconsistencies in transfer of blood to POCT devices
- Identify problems processing pediatric specimens on modern laboratory automation
Getting POC NAAT Tests into the Home
Paul Yager, PhD, Professor, Bioengineering, University of Washington
- Ongoing changes in US domestic healthcare
- POC NAAT Testing
- New opportunities for home testing
8:30 Chairperson’s Remarks
James H. Nichols, PhD, DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine
8:35 Specimen Collection Devices for Infectious Diseases Testing
Marek Smieja, MD, PhD, Professor, Pathology & Molecular Medicine, McMaster University; Head, Microbiology,
Hamilton Regional Laboratory Medicine Program
Diagnostic tests for infectious diseases require appropriate specimens, like throat, respiratory tract, urine, stool or skin, that could be collected by minimally-trained staff or by the patient. Anatomically, collection devices need to be efficient,
safe, and yield reproducible results. We have developed and studied collection devices for oral, throat, nasal, skin, and stool specimens, for antibody, antigen, or nucleic-acid assays. Collection devices and transport media are essential
for high-quality infectious diseases testing, in laboratories and in point-of-care.
9:05 New POCT Devices in the Near Future: What Will POCT Look Like?
William Clarke, PhD, MBA, DABCC, Associate Professor of Pathology, Johns Hopkins University School of Medicine
In this lecture, we will discuss the current state of POCT and where developments in technology will change the types of devices that are available. Specifically, we will discuss gaps in existing technology and clinical care relative to existing
devices, and how research and technology development can meet those challenges. In addition, we will discuss emerging technology that may become POCT products in the future.
9:35 Innovations in Phlebotomy: Beyond the Needle and Vacutainer for Point-of-Care Sample Collection
James H. Nichols, PhD, DABCC, FAACC, Professor, Pathology, Microbiology and Immunology; Medical Director,
Clinical Chemistry and Point-of-Care Testing, Vanderbilt University School of Medicine
Hospital acquired anemia from routine laboratory testing is a concern for critically ill patients. POCT utilizes minimal sample volumes and has advantages over modern laboratory automation equipment that cannot process, aliquot or sample directly
from pediatric microtainers. This presentation will identify innovations in blood collection devices that are minimizing sample volumes, standardizing phlebotomy processes and integrating POCT with sample collection.
10:05 Coffee Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)
11:00 CLIA Regulations and Waived Testing
Karen W. Dyer, MT(ASCP), DLM, Director, Division of Clinical Laboratory Improvement and Quality, Centers for Medicare
& Medicaid Services
This presentation will provide background on the CLIA law and corresponding regulations with focus on requirements for waived, moderate and high complexity testing. Updated CLIA laboratory statistics will be presented as well as findings from
Certificate of Waiver educational surveys.
11:30 FDA Update on CLIA Waiver and Point-of-Care Testing
Peter Tobin, PhD, Chemist, Division of Program Operations and Management, Office of In Vitro Diagnostics and
Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration
This presentation will provide an update on recent developments, regulatory pathways and study design recommendations for CLIA waiver, including how the Dual 510(k) and CLIA Waiver by Application pathway can help speed the process of bringing
simple and accurate tests to CLIA-waived settings through valuable time and study efficiencies. Study design recommendations for over-the-counter tests and non-waived point-of-care tests will also be discussed.
12:00 pm Improving the Diagnosis and Treatment of Sexually Transmitted Infections
John Clarkson, PhD, Founder & Non-Executive Director, Atlas Genetics
Atlas Genetics is broadening access to diagnostic tests for sexually transmitted infections. Two complementary approaches are being used - rapid, POC molecular Chlamydia and Gonorrhoea tests for use in STD and planned parenthood clinics, and
a physician-mediated digital health solution where patients self-collect specimens at home for remote analysis.
12:15 Microfluidics & Design for Manufacture
Jason Hayes, PhD, Head, Product Development, MiniFAB
Taking a microfluidic product from concept stage through to mass manufacture requires rigorous application of Design-for-Manufacture (DFM) principles at every stage of development. A design-for-manufacture approach ensures products can rapidly
transition from prototype to high volume delivery simply and at lower overall cost.
12:30 Luncheon Presentation: Out-Sourced Diagnostics Device Development: Getting It Right
Yan Lin Lye, MPhil, Head, Clinical Diagnostics Asia, Global Medical Technology, Cambridge Consultants
- How to know when you're ready to outsource
- Understanding the art of the possible
- Critical questions that challenge potential partners
- The top three considerations when selecting your partner
1:00 Refreshment and Cookie Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)
1:30 Chairperson’s Remarks
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH
1:40 Naat Testing for Pathogens at Home or under a Tree
Paul Yager, PhD, Professor, Bioengineering, University of Washington
Our lab is pursuing development of low-cost rapid diagnostics to identify the agents of infectious diseases; these tools must be appropriate for use in low-resource settings. Under support of DARPA and the Bill & Melinda Gates Foundation,
we have been developing single-use, disposable, inexpensive swab-to-result NAAT tests with human samples. These tests use isothermal amplification of DNA or RNA, coupled to lateral flow detection.
2:10 Sample Preparation and Discretization Strategies for Portable Multiplexed Nucleic Acid Diagnostics
Don L. DeVoe, PhD, Professor, Mechanical Engineering, University of Maryland, College Park
Microfluidic diagnostics for use in near-patient settings demand the development of simple, inexpensive, and robust methods for sample preparation, enabling diagnostic targets to be isolated from blood with minimal instrumentation and
operator input. This talk will describe new methods for sample preparation using thermoplastic microfluidics suitable for use at the point of care, combined with a novel technique for passive sample discretization enabling effective
multiplexed analysis in the low-cost devices.
2:40 Point-of-Care Infectious Disease Diagnosis via Inexpensive, User-Friendly Nucleic Acid Testing Devices
Angelika Niemz, PhD, Arnold and Mabel Beckman Professor, Keck Graduate Institute
Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) cause sexually transmitted infections that can lead to pelvic inflammatory disease, ectopic pregnancy, or infertility in women. To enable diagnosis and treatment in the same clinical
encounter, our goal is to develop a CLIA-waived minimally instrumented system for POC detection of CT/NG infections that combines the sensitivity of central laboratory based nucleic acid amplification tests with the simplicity of lateral
flow tests.
3:05 A Multiplex Platform for Precision Medicine at the Point of Care: Sepsis
Chris Myatt, PhD, CEO, MBio Diagnostics, Inc.
Sepsis presents a complex disease state that requires precision medicine results in real time. A multiplex panel of biomarkers and algorithmic analysis—delivered at the point-of-care—can provide essential data and information
on-the-spot. We report progress on applications in risk stratification and therapy optimization.
3:20 Consumable Case Studies: Boosting Sensitivity, Reducing COGS
Richard Spero, PhD, CEO, Redbud Labs
The wrong instrument design decisions can doom a diagnostic product, especially when moving from a bench-top assay to a cartridge format. We will discuss case studies of cartridge designs that were limited by assay sensitivity, speed,
or cost, then show how our microfluidic mixing chip, MXR, addressed the challenge.
3:35 Refreshment Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)
4:20 Chairperson’s Remarks
Gerald J. Kost, MD, MS, PhD, Director, Point-of-Care Testing Center for Teaching and Research (POCT•CTR);
Emeritus Professor, Pathology and Laboratory Medicine, School of Medicine, University of California, Davis
4:25 Rethinking Strategies to Increase Resilience in Disasters: Public Health Perspective of Technical and Community Solutions at Points of Need
Ann M. Sakaguchi, MPH, PhD, Specialist, Director, Pacific Emergency Management, Preparedness, Response,
Information Network and Training Services (Pacific EMPRINTS), National Disaster Life Support Regional Training Center-Pacific, Anthropology, University of Hawaii, College of Social Sciences
This presentation sets the stage by: a) informing the audience that 2017 was the costliest year in U.S. history for natural disasters, 2) alerting people that patients with chronic and acute medical conditions often experience declining
health conditions at evacuation centers that can be further exacerbated by infectious disease outbreaks, and 3) describing why rapid detection via POCT is an essential technical and community solution at points of need.
4:55 Is Instrument-Free Molecular Detection of Highly Infectious Diseases Possible?
Haim H. Bau, PhD, Professor, Mechanical Engineering and Applied Mechanics, University of Pennsylvania
We describe a two-stage multiplexed isothermal assay and an inexpensive, simple, rapid platform for molecular detection of pathogens at the point of care. Our system isolates, concentrates, amplifies, detects, and quantifies target nucleic
acids and interfaces with a smartphone for sensing, data analysis, and communications. We have successfully tested our assay with samples of Zika virus patients in Panama.
5:25 Capabilities of Select Multiplex Point-of-Care Technologies
Hayden Huang, Senior Engineer, Center for Science, Technology and Engineering, Government Accountability Office
We examined the performance characteristics of eight multiplex point-of-care technologies, currently available or under development, for diagnoses of infectious diseases. These technologies met or nearly met requirements of two federal
agencies. We found that key performance characteristics, such as sensitivity and time to result, varied among the different technologies. These findings raise questions about how end users can determine which technology is most appropriate
for their purposes.
5:55 Using Drones Instead of Couriers to Deliver Specimens to Laboratories
Timothy Amukele, MD, PhD, Assistant Professor of Pathology, Johns Hopkins University School of Medicine
Several recent reports demonstrate that medical samples can be transported by drones without affecting the laboratory results. In addition, drones can go where roads are non-existent or poor (rural areas, across bodies of water) as well
as outperform cars in traffic and in unusual road configurations e.g. two hospitals separated by a highway. Has the time come to replace vehicle-based couriers with drones? What are the real-life barriers to achieving this vision?
6:25 End of Enabling Point-of-Care Diagnostics
6:00 Dinner Short Course Registration (Independence Foyer)
6:45 - 9:15 pm Recommended Dinner Short Course*
SC6: Rapid Diagnostics for Antimicrobial Stewardship
Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and Virology, Children’s Hospital Los Angeles; Associate Professor, Pathology and Laboratory Medicine, Keck School of Medicine, University of Southern California
April Abbott, PhD, D(ABMM), Director, Microbiology, Deaconess Health System
Amanda Harrington, PhD, Associate Professor, Pathology; Medical Director, Microbiology, Loyola University Medical Center
*Separate registration required