The point-of-care diagnostic market is expected to reach over $38 billion by 2022, and for good reason – POC diagnostics are quicker and more efficient, can eliminate follow up visits, can reach communities without access to major medical facilities, and save money in the healthcare system. Cambridge Healthtech Institute’s 8th Annual Point-of-Care Diagnostics program will examine new developments and future goals of major diagnostic companies, as well as the integration of current POC diagnostics in hospital systems, pharmacies, and resource-constrained settings. Special attention will be paid to emerging technologies in the field, from sensors to wearables and more. We will also discuss the regulatory and reimbursement landscape in point-of-care diagnostics. Test developments and end users alike will discuss implementation challenges, adoption strategies, and new and emerging tools that continue to shape the future of the field.

Final Agenda

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Arrive Early for:

SUNDAY, MARCH 10, 2:00 - 5:00 PM (AFTERNOON SHORT COURSES)
SC2: Coverage and Reimbursement for Advanced Diagnostics - Detailed Agenda

SUNDAY, MARCH 10, 5:30 - 8:30 PM (DINNER SHORT COURSES)
SC10: Regulatory Compliance in Molecular Diagnostics - Detailed Agenda
SC13: Microfluidics and Lab-on-a-Chip Devices for POCT: Technologies and Commercialization - Detailed Agenda

MONDAY, MARCH 11, 8:00 - 11:00 AM (MORNING SHORT COURSES)
SC18: Commercialization Boot Camp: Manual for Success in Molecular Diagnostics - Detailed Agenda

Monday, March 11

10:30 am Conference Program Registration Open  (South Lobby)

INTEGRATION OF POINT-OF-CARE DIAGNOSTICS IN HOSPITAL SETTINGS
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11:50 Chairperson’s Opening Remarks

Elsie Yu, PhD, DABCC, FACB, System Director, Chemistry, Toxicology and Point-of-Care Testing, Geisinger Medical Laboratories

12:00 pm Optimizing POCT Utilization in the Hospital: Impact on Cost, Quality of Care, and Patient/Provider Satisfaction

Gyorgy Abel, MD, PhD, Director, Molecular Diagnostics, & Clinical Chemistry/Immunology, Division of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, MA

POCT in the hospital setting tends to be resource intensive and more expensive than central laboratory testing but can save money in clinical situations where it makes a significant impact on clinical decision-making and when short turnaround time is needed. This talk will review 1) clinical scenarios in the hospital where POCT can improve outcomes and decrease overall healthcare costs, and 2) related innovative technologies, cost analysis and decision-support.

12:30 How We Use Point-of-Care Testing to Leverage the Growing Need of a Multi-Hospital Health Care System

Elsie Yu, PhD, DABCC, FACB, System Director, Chemistry, Toxicology and Point-of-Care Testing, Geisinger Medical Laboratories

At Geisinger, we employ POCT in a wide variety of settings. At hospitals and clinics, POCT typically is used to expedite patient management decision. In the home setting, testing is done to monitor and manage patient conditions away from the hospitals. This allows patients to rest in the comfort of his/her home while keeping healthcare costs down. In this presentation, we will provide an overview of the various point-of-care solutions we employ.

1:00 Session Break

1:10 Enjoy Lunch on Your Own

2:10 Session Break

2:30 Chairperson’s Remarks

Ping Wang, PhD, DABCC, Chief, Clinical Chemistry, Director, Core Laboratory Hospital of University of Pennsylvania

2:40 Clinical Needs, Validation and Implementation Strategies for Novel Point-of-Care Technologies

Ping Wang, PhD, DABCC, Chief, Clinical Chemistry, Director, Core Laboratory 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.

3:10 Medical-Legal Aspects of Direct-to-Consumer Testing

Timothy Craig Allen, MD, JD, Professor and Chair, Pathology, University of Mississippi Medical Center

Direct-to-consumer testing is a dynamic, growing business that is regulated to a great extent by the U.S. Food and Drug Administration. Perspectives in its regulation differ, and challenges exist in how accurate, reliable, and cost-effective direct-to-consumer testing can be best provided. Understanding its regulation and related medical-legal issues is critical for its successful future.

3:40 Challenges Related to User Compliance When Implementing POCT Within a Hospital Setting

Julie Shaw, PhD, FCACB, Head, Division of Biochemistry and Director for POCT, Department of Pathology and Laboratory Medicine, The Ottawa Hospital and EORLA

This presentation will outline practical challenges related to POCT operator compliance with hospital policies and procedures surrounding quality assurance for POCT.  Specifically, the following areas will be explored through the presentation:  Positive patient identification, preanalytical considerations, training and competency, quality control and results interpretation.  The presentation will also include a discussion on strategies aimed at dealing with the challenges outlined.

4:10 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.

4:40 Refreshment Break and Transition to Plenary Session

5:00 Plenary Keynote Session  (Room Location: 3 & 7)

6:00 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:30 Close of Day

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Tuesday, March 12

7:30 am Registration Open and Morning Coffee (South Lobby)

8:00 Plenary Keynote Session  (Room Location: 3 & 7)

9:15 Refreshment Break in the Exhibit Hall with Poster Viewing

POINT-OF-CARE IN PHARMACIES
4

10:15 Chairperson’s Remarks

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

10:25 Technical and Practical Advances Necessary to Maximize the Value of Point-of-Care Testing by Pharmacists

Donald Klepser, PhD, MBA, Associate Professor and Vice Chair, Pharmacy Practice, University of Nebraska Medical Center

This presentation will look at the future of the pharmacy-based point-of-care testing. In particular, it will focus on the advances necessary to maximize the value of testing in pharmacy settings. This will include the technical advances necessary, such as the type and performance of the tests, and the practical advances, such as workflow and regulatory changes.

10:55 CO-PRESENTATION: Community Pharmacists Can Effectively Provide POC HCV and HIV Ab Screening

Betty J. Dong, PharmD, FASHP, FAPHA, FCCP, AAHIVP, Professor, Clinical Pharmacy and Family and Community Medicine, University of California Schools of Pharmacy and Medicine

Maria Lopez, PharmD, President, Clinical Pharmacy Services, Mission Wellness Pharmacy

Community pharmacists from one independent local pharmacy provide POC HCV and HIV Ag/AB screenings in collaboration with the San Francisco Department of Public Health. To date, more than 300 HCV-Ab POC screenings have been conducted since the initial pilot began. The HCV POC screening began in 2016. Incorporating pharmacy led HIV and HCV screening into routine pharmacy work for the at-risk community is feasible.

11:25 Point-of-Care Testing and New Community Practice Models: Not Business as Usual

Kenneth C. Hohmeier, PharmD, Director, Community Affairs, Associate Professor, Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center

An unprecedented level of innovation and practice evolution is occurring in the community pharmacy industry allowing pharmacists to engage in more direct patient care services such as Point-of-Care Testing (POCT). Learn how to spot these innovators and understand future trends in community pharmacy which will allow for scalable POCT implementation.

11:55 Lyophilizing PCR Master Mixes for Molecular Diagnostic Assays

Timothy Pearcy, Managing Director, Executive, BIOLYPH LLC

BIOLYPH provides lyophilization services for Molecular diagnostic reagents. A single Master Mix LyoSphere™ can contain Enzymes, Oligonucleotides, Dyes, RNAse Inhibitors, Cations, dNTPs, Buffers and Excipients in a stable, consistent form, which rehydrates instantly and can be packaged into any device.

12:10 pm NEW: Bringing the Next Generation of PoC Multiplexed and Multimodality Diagnostics by Leveraging a Nanopore Based Platform

Trevor Morin, CSO, Biochem, Two Pore Guys, Inc.

Using solid-state nanopores for single-molecule analysis of human and agricultural samples, 2PG provides a technology that is multimodal, highly accurate, rugged and fast, at an affordable price point. I'll present the data from partner studies that show its utility in infectious disease, oncology and pharmacology. 

12:25 Session Break

12:35 Luncheon Presentation I: Next-Generation Sample Prep: Faster, Smaller, and Cartridge-Ready

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

Point of care molecular may be the fastest growing segment in diagnostics, but it’s a small fraction of the overall molecular testing market. We are developing on-cartridge sample prep to enable lab-quality performance, helping more molecular tests move to POC.

1:05 Late Breaking Presentation

1:35 Refreshment Break in the Exhibit Hall with Poster Viewing

POINT-OF-CARE IN PHARMACIES (CONT.)
4

2:05 Chairperson’s Remarks

Donald Klepser, PhD, MBA, Associate Professor and Vice Chair, Pharmacy Practice, University of Nebraska Medical Center

2:10 CLIA-Waived POCT and Outpatient Stewardship

Donald Klepser, PhD, MBA, Associate Professor and Vice Chair, Pharmacy Practice, University of Nebraska Medical Center

The White House has published a national action plan to combat antibiotic resistant bacteria. Central to the plan is the use of POC diagnostics. This talk will review the goal of the action plan and review data regarding the use of CLIA-waived POCT to improve antibiotic use in the outpatient setting. Areas of future needs will be discussed.

2:40 Rapid Diagnostic of the Pharmacy Point-of-Care Legal Landscape

Tim Frost, PharmD, Pharmacy Regulatory Affairs Advisor, Retail Chain Pharmacy; Adjunct Professor of Pharmacy Law, Pacific University School of Pharmacy

The presentation will review the opportunities and barriers within the regulatory landscape of point-of-care testing in community pharmacies. The presentation will address the uptake of POCT in community pharmacies, the variation of pharmacy POCT laws between states, and the authority for pharmacists to act on the test results through collaborative practice agreements, statewide protocols, and independent prescribing.

3:10 PANEL DISCUSSION: What’s Next in POCT for Pharmacy?

Moderator:
Donald Klepser, PhD, MBA, Associate Professor and Vice Chair, Pharmacy Practice, University of Nebraska Medical Center

Panelists:

Kenneth C. Hohmeier, PharmD, Director, Community Affairs, Associate Professor, Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center

Tim Frost, PharmD, Pharmacy Regulatory Affairs Advisor, Retail Chain Pharmacy; Adjunct Professor of Pharmacy Law, Pacific University School of Pharmacy

Maria Lopez, PharmD, President, Clinical Pharmacy Services, Mission Wellness Pharmacy

This panel will discuss where the field of POCT for pharmacy is headed in the next ten years.

3:40 A Multiplexed Platform for Point-of-Care Precision Medicine

Chris Myatt, PhD, CEO, MBio Diagnostics, Inc.

MBio has developed a point-of-care platform that has been adapted to a variety of testing applications. In medicine, it would be transformative to deliver precision medicine answers in the context of acute care. In particular, sepsis and acute infections present complex disease states that require precision medicine results in real time.  With multiple biomarkers, and often algorithmic approaches to analysis, a multiplex platform is essential to delivering the necessary data on-the-spot.  We will present the architecture and design features of the MBio Diagnostics LightDeck® evanescent planar waveguide sensor. We will then detail host response biomarker panels with applications in risk stratification and therapy optimization.

4:10 St. Patrick’s Day Celebration in the Exhibit Hall with Poster Viewing

5:00 Breakout Discussions in the Exhibit Hall

6:00 Close of Day

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Wednesday, March 13

7:30 am Registration Open and Morning Coffee  (South Lobby)

8:00 Plenary Keynote Session  (Room Location: 3 & 7)

10:00 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall

POINT-OF-CARE IN RESOURCE-LIMITED SETTINGS
4

10:50 Chairperson’s 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

11:00 FEATURED PRESENTATION: Point-of-Care Biomarkers in Vietnam: International Exchange, Needs Assessment, and Spatial Care Paths

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

We will address needs assessment and strategic planning for rapid diagnosis and treatment of AMI patients in Central Vietnam, a limited-resource region suitable for POCT. Early upstream cardiac troponin (cTn) testing on Spatial Care PathsTM will expedite transfers directly to hospitals capable of intervening, improving outcomes following coronary occlusion. POC Coordinator certification and financial support will enhance standards of care cost-effectively. Training young physicians pivots on high value evidence-based learning when POC cTnT/I biomarkers are in place for fast decision making, especially in emergency rooms.

11:20 FEATURED PRESENTATION: The Status of POC Coordinators in Vietnam and the Future of Rapid Response at Points of Need

Chi Thuy Loan Nguyen, MD, Medical Laboratory Doctor, Point-of-Care Coordinator, Franco-Vietnamese Hospital (FV Hospital)

Point-of-care diagnosis, a relatively new concept in Vietnam, presents several challenges of implementation and management, but also offers striking advantages for rapid response, patient-focused test clusters, and equitable rural healthcare. This talk reviews needs in limited-resource regions, presents successful POCT in a referral hospital, recommends the development of a national network of POC coordinators, underscores the importance of education and certification, and projects future most impactful practice at points of need in Vietnam.

11:40 C-THAN: A Newly Formed Center for Innovation in Point-of-Care Technologies to Improve Treatment of HIV/AIDS Infected Individuals in Low- and Middle-Income Countries

Sally McFall, PhD, Deputy Director, Biomedical Engineering Department, Northwestern University, Center for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern University (C-THAN)

C-THAN’s mission is to support the development and commercialization of point-of-care technologies for HIV/AIDS treatment in low-and-middle-income countries. The Center, composed of administrative, technology development/refinement, clinical translation and validation, and technology training and dissemination cores, operates in concert to deliver: 1) clinical needs assessment; 2) collaboration with scientists, physicians, and engineers; 3) development of technical, clinical, industrial and regulatory partnerships; 4) clinical testing of prototypes; 5) training opportunities for stakeholders.

12:05 pm NEW: Stabilization of Biologicals and Bioplasmonic Devices for Point-of-Care Applications

Joseph Slocik, PhD, Senior Research Scientist, Air Force Research Lab, WPAFB

In this talk, I will highlight an approach that we have developed in stabilizing biomolecules in extending shelf-life and temperature stability for eliminating the cold-chain logistics. In addition, I will describe recent research in developing low-cost bioplasmonic devices for the sensitive detection of biomarkers of interest. These devices are ideal for application in resource-limited settings.

12:30 Session Break

12:40 Enjoy Lunch on Your Own

1:10 Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing

SENSORS, WEARABLES, AND EMERGING POC TECHNOLOGIES
4

1:50 Chairperson’s Remarks

Sally McFall, PhD, Deputy Director, Biomedical Engineering Department, Northwestern University, Center for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern University (C-THAN)

2:00 Low-Cost Disposable Point-of-Care Bioanalytical Devices Based on Porous Materials for Detection of Pathogens in the Developing World

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

Presented will be three approaches for identification of pathogens: 1) via antibodies specific to pathogens, 2) via proteins from the pathogens, and 3) via DNA or RNA sequences derived from the pathogens. All projects have as goals prototypes of simple, sensitive, paper-based, disposable, instrument-free systems that perform rapid point-of-care tests.

2:25 Paper-Based Surface-Enhanced Raman Scattering Lateral Flow Strips for Point-of-Care Applications

Nianqiang (Nick) Wu, Professor, Mechanical and Aerospace Engineering, West Virginia University

This presentation will present our effort to develop plasmonic nanostructures for amplifying surface-enhanced Raman scattering (SERS) signals. It will also show how to incorporate SERS sensors into paper-based lateral flow strips (PLFS) as point-of-care tools. The PLFS is composed of the on-chip sample pretreatment, flow control and detection components. Moreover, this talk will demonstrate measurement of the traumatic brain injury (TBI) protein biomarkers in clinical samples by the SERS-based PLFS.

2:50 Smartphone Optosensing Platform as Mobile Health Devices for Point-of-Care Diagnostics

Li-Ju Wang, PhD, Assistant Research Professor, Mechanical and Materials Engineering, Washington State University

The capabilities inherent in smartphones represent a huge, untapped opportunity to improve point-of-care (POC) diagnostics. Smartphone optical sensing platform adapts smartphone features including fast computing power, internet connectivity, high-quality cameras and long-lasting power/batteries to increase POC diagnostic sensitivity and specificity to clinical level through optical sensing and machine-interpreted results. 12 viral and bacterial infectious diseases and 4 types of autoantibody were clinically validated on our smartphone optical sensing platform.

3:10 Point of Care Molecular Diagnostics for Infectious Disease Diagnosis

Angelika Niemz, PhD, Professor, Applied Life Sciences, Keck Graduate Institute

We are developing a rapid, affordable, and easy to use minimally instrumented nucleic acid testing system for point of care infectious disease diagnosis. This platform technology is designed to detect viruses or bacteria from blood, urine, or swab samples through integrated sample preparation, isothermal nucleic acid amplification, and lateral flow detection.

3:30 Session Break

REIMBURSEMENT IN POINT-OF-CARE DIAGNOSTICS
4

3:40 Chairperson’s Remarks

Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories

3:45 PANEL DISCUSSION: The Value Proposition of Point-of-Care Testing

John Warren, Senior Director, McDermottPlus Consulting

Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories

Joseph Rubino, PhD, Senior Reimbursement Specialist, Cepheid

Chelse Dyer, Senior Director, Business Operations, Abbott

Christos J Petropoulos, PhD, Vice President R&D, Monogram Biosciences, Inc., Laboratory Corporation of America

Maria Lopez, PharmD, President, Clinical Pharmacy Services, Mission Wellness Pharmacy

Join a panel of experts from payers, providers and patients discussing the value and future of point-of-care testing. During this informative panel discussion, listen to these leaders as they discuss:

• Reimbursement challenges for point-of-care testing
• How point-of-care testing adds value to the patient experience
• What role point-of-care testing plays in a value-based payment system
• What new advancements in point-of-care testing are on the horizon

5:15 Close of Conference Program

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