CHI's 2nd Annual

Decentralized POC Testing

Advancing Testing in the Pharmacy, at-Home, and Beyond

August 20 - 21, 2024 ALL TIMES EDT

Point-of-care testing has emerged as a key diagnostic tool in the public health toolbelt. Although rapid testing surged during the COVID-19 pandemic, there has been a challenge in integrating additional use cases into healthcare workflows. At Cambridge Healthtech Institute’s 2nd Annual Decentralized Point-of-Care Testing, industry experts will cover the current status of a variety of point-of-care tests across different regions. Large pharmacies as well as community pharmacies and independent clinics are starting to make point-of-care testing available. The conference will explore how point-of-care tests can be sustainability integrated into health systems, as well as how reimbursement models can be leveraged for novel testing such as multiplex or syndromic tests. The conference will also cover the relationship between testing availability and antibiotic stewardship, the state of at-home testing, and how new tests can be scaled and commercialized.

Tuesday, August 20

Registration Open10:30 am

PLENARY SESSION

11:30 am PLENARY KEYNOTE PRESENTATION:

FDA Perspectives: Trends and Challenges

Courtney H. Lias, PhD, Director, OHT7: Office of in vitro Diagnostic Devices, United States Food and Drug Administration (FDA)

12:00 pm PLENARY PANEL:

Laboratory-Developed Tests: Proposed Rule, Reclassification Activities, Potential Impact, and Path Forward

PANEL MODERATOR:

B. Melina Cimler, PhD, CEO & Founder, PandiaDx LLC

Laboratory-developed tests (LDTs) are an important part of healthcare. The FDA released a final rule on May 6, 2024, to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal FD&C Act, including when the manufacturer of the IVD is a laboratory. FDA issued a policy under which the FDA intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach.  

This panel brings together stakeholders to: 

  • Discuss elements of the proposed rule, including classification of IVDs 
  • Impact on various stakeholders and expected activities  
  • CMS vs. FDA roles as to oversight of laboratory tests  
  • Regulation of LDTs under the IVDR?
PANELISTS:

Stefan Burde, PhD, Director, Global Strategic Business Development, TÜV SÜD America, Inc.

Girish Putcha, MD, PhD, Principal & Founder, Precision Medicine & Diagnostics

Lakshman Ramamurthy, PhD, Vice President, Regulatory Affairs, GRAIL

Anna Scrimenti, Associate Director, Public Policy & Advocacy, Association for Molecular Pathology

Enjoy Lunch on Your Own1:10 pm

Organizer's Welcome Remarks2:25 pm

Erin Kadelski, Associate Project Manager, Production, Cambridge Healthtech Institute

NOVEL TECHNOLOGIES FOR DECENTRALIZED POINT-OF-CARE TESTING

2:30 pm

Chairperson's Remarks

Giulia Pilla, PhD, Clinical Lead, Nostics

2:35 pm

Point-of-Care Smartphone-Enabled Fluorescence Microscopy Setup for Diagnostic Applications

Umer Hassan, PhD, Assistant Professor, Electrical & Computer Engineering, Rutgers University

Dr. Hassan's lab has developed a 3D-printed, portable, smartphone enabled fluorescence microscopy setup for point-of-care diagnostic applications. This hand-held setup can be easily used to image cells of interest or other micro-nano particles used in different biological assays.The validation of the device with clinical samples will be shown in the talk. The setup is user-friendly and can be easily adaptable to different diagnostic applications.

3:05 pm

A Novel Point-of-Care Diagnostics Platform to Revolutionize Antibiotic Prescription Practices

Giulia Pilla, PhD, Clinical Lead, Nostics

Nostics is developing a point-of-care diagnostics platform integrating photonics, nanotechnology, and machine learning, to detect and identify pathogens at species-level within minutes. With our first application DUTI, we target the identification of bacteria causing urinary tract infections from urine samples during the first patient visit, enabling more effective antibiotic treatments. The platform can be expanded to other pathogens (e.g., fungi) and sample types (e.g., blood cultures), revolutionizing infectious disease testing.

3:35 pm

Developing Cost-Effective, Rapid-Response Diagnostics for Snakebite Envenomation in Decentralized Healthcare Settings

Jonas Jürgensen, MSc, Co-Founder, CEO, VenomAid

Snakebite envenoming, one of the world's most neglected diseases, causes significant morbidity and mortality annually. Diagnosis largely relies on patient history and symptomatic assessment, with the availability of diagnostic tests varying globally. Timely diagnosis and treatment are warranted, emphasizing the need for novel, rapid, and affordable diagnostics to improve outcomes in both established and decentralized healthcare settings. This could enhance patient outcomes and reduce costs in resource-scarce healthcare institutions worldwide.

Refreshment Break in the Exhibit Hall with Poster Viewing4:05 pm

4:45 pm KEYNOTE PRESENTATION:

Point-of-Care Diagnostics for Global Health

David Erickson, PhD, SC Thomas Sze Director, Professor, Director, PORTENT Center for Point-of-Care Technologies for Nutrition, Infection, and Cancer in Global Health, Mechanical, and Aerospace Engineering, Cornell University

In this talk, I will discuss our recent work on the development of, primarily, point-of-care diagnostic technologies for the differential diagnosis of febrile illnesses, quantification of antibiotic resistance, and some virus-causing cancers. In addition to covering the basic engineering science advancements that led to the development of these technologies, I will discuss our strategies for deployment and commercialization.

5:15 pm

Innovations to Enable Distributed Diagnostics to Drive Public Health, Medicine and Clinical Trials

Michael J. Mina, MD, PhD, CSO, eMed

Decentralized diagnostics have proven value as critical medical and public health tools, from self pregnancy tests, to HIV self testing, to the international COVID-19 response and much more. However, truly decentralized POC testing is too often seen as antithetical to public health for lack of robust test monitoring, reporting and connectivity to EHRs. In 2022, the Biden Administration and the NIH launched the Home Test to Treat Program to leverage home diagnostics to support fast treatment and public health reporting. That program leveraged eMed's Test-to-Treat platform, developed in conjunction with the CDC, and enabled millions of Americans to return to the US during the early days of the pandemic, based on a self test. With appropriate innovations, distributed diagnostics can overcome traditional barriers and accelerate medicine, trials and responses to public health emergencies.

Close of Day5:45 pm

Wednesday, August 21

Registration Open7:15 am

Interactive Discussions with Continental Breakfast7:30 am

Interactive discussions provide an opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. Please visit the interactive discussions page on the conference website for a complete listing of topics and descriptions.

TABLE 1: How to Successfully Partner with DDDI and BARDA (IN-PERSON ONLY BREAKOUT)

Christopher J. Knickerbocker, Contracting Officer Representative, United States Department of Health and Human Services

Kristy Stoudt, PhD, Biologist and Project Officer, Biomedical Advanced Research and Development Authority (BARDA)

  • Preliminary inquiries and interactions
  • Funding mechanisms
  • BAA solicitation process (Stage I – III)
  • Key questions before starting a submission/advice for submitters​

SUSTAINABLE AND SCALABLE DECENTRALIZED TESTING MODELS

8:25 am

Chairperson's Remarks

Donald G. Klepser, PhD, MBA, Professor and Senior Associate Dean for Academic Affairs, College of Pharmacy, University of Nebraska Medical Center

8:30 am

Reimbursement Models That Support Sustainable and Scalable Point-of-Care Testing Services in Non-Traditional Settings

Donald G. Klepser, PhD, MBA, Professor and Senior Associate Dean for Academic Affairs, College of Pharmacy, University of Nebraska Medical Center

With recent legislative changes, many regulatory barriers to providing point-of-care testing services in pharmacies and other non-traditional settings have been removed. Reimbursement for services in these settings remains as the largest barrier to wide-scale adoption and sustainability. While a barrier, models exist to reimburse providers for their services. In this session, current and potential reimbursement models for non-traditional settings will be presented along with the role diagnostic manufacturers can play in supporting reimbursement efforts.

9:00 am

Transforming Colorectal Cancer Screening: A Collaborative, Novel Approach to Patient-Direct Cologuard Testing

Tom Draney, MHA, Associate Director, Customer Experience, Exact Sciences

Kate Sowerwine, MD, CMO, Recuro Health

Explore the success story of our innovative collaboration, where Recuro Health's virtual care delivery seamlessly integrates with Exact Sciences, bringing large-scale colorectal cancer screening and care to patients nationwide within the comfort of their homes. Our talk will highlight the program's practical value, the rich data generated, and its notable success so far for Exact Sciences.

9:30 am

Zero to Waiver: Challenges, Innovation, Lessons and Principles

Chris Harder, PhD, Chief Technology Officer, Kenota Health

Join me on a journey of developing an IVD medical device from scratch to obtaining CLIA Waiver. The challenges of creating a non-conventional Point-of-Care IVD are unique and varied. I will take you through the development process during the pandemic (non-COVID), from concept to regulatory clearance. I’ll describe our innovation, share the challenges we encountered, explore the lessons we learned, and outline the principles we believe enable success. The goal is to inform, encourage, share, and inspire others on this journey and suggest ways to collaborate in bringing safe and effective products to market as soon as possible.

Networking Coffee Break10:00 am

10:30 am

Operationalizing a Service and Expanding the Scope of the Community Pharmacist

Brian Strong, PharmD, Director, New Services Development, Walgreens Co.

As patient needs evolved throughout the pandemic, Walgreens stepped up to uncover and address the challenges and root issues that continue to impact community health. From parking lot testing sites to over 7000 testing locations, learn how Walgreens operationalized testing, assessment, and treatment services to not only offer alternatives to traditional channels but also allow our pharmacists to provide services to and help bridge care gaps.

11:00 am PANEL DISCUSSION:

Pushing Past the Tipping Point: Scalability of Pharmacy-Based Testing Models

PANEL MODERATOR:

Michael E. Klepser, PharmD, FCCP, FIDP, Professor, Ferris State University College of Pharmacy

During this session, panelists will: discuss the current state of community-based POCT services, provide prospective about the types of POCT and services that have been successful, identify historical barriers that have begun to fall, discuss what needs to happen to allow for testing services to continue to grow and expand, and suggest future tests and services that may be viable in this space.

PANELISTS:

Brian Strong, PharmD, Director, New Services Development, Walgreens Co.

John Warren, Owner and Principal Consultant, Gettysburg Healthcare Consulting, LLC

Donald G. Klepser, PhD, MBA, Professor and Senior Associate Dean for Academic Affairs, College of Pharmacy, University of Nebraska Medical Center

Enjoy Lunch on Your Own12:00 pm

THE ROLE OF POCT AT THE PHARMACY LEVEL

1:10 pm

Chairperson's Remarks

Adam S. Chesler, PharmD, MBA, Senior Vice President, Pharmacy Integration and Strategic Alliances, VillageMD

1:15 pm

Nationwide Study of Influenza POCT in U.S. Community Pharmacies 

Kenneth C. Hohmeier, PharmD, Associate Professor, Director of Community Affairs, PGY-1 Community-Based Pharmacy Residency Program, The University of Tennessee Health Science Center

Community pharmacists remain one of the most accessible healthcare providers in the U.S., with 9 in 10 Americans living within five miles of a pharmacy. Post-pandemic, there continues a shift in the perception of the role of the pharmacist as it relates to acute infectious disease treatment. However, there is sparse literature on pharmacist POCT service impact. This session will shed light on the topic with insights from a nationwide study.

1:45 pm

Supporting CLIA-Waived POCT in Community Pharmacies

Michael E. Klepser, PharmD, FCCP, FIDP, Professor, Ferris State University College of Pharmacy

Integrating CLIA-waived POCT into the workflow of a pharmacy is critical to the success of a testing service. Means to track scheduling, clinical notes, and other data are essential for such programs. Additionally, understanding and tracking compliance with state-level legislative requirements for disease reporting, record keeping, and training of personnel is vital.

2:15 pm

Empowering Pharmacists—Point-of-Care Testing for Enhancing Patient Care 

Adam S. Chesler, PharmD, MBA, Senior Vice President, Pharmacy Integration and Strategic Alliances, VillageMD

This presentation aims to empower pharmacists and technicians in point-of-care testing (POCT) for improved patient care. Attendees will gain insights into the pivotal role pharmacists and technicians can play in POCT, explore the process and workflow of pharmacy-conducted POCT, and discover how these practices can elevate value-based care.

2:45 pm

How Point-of-Care Testing Can Fight Antibiotic Resistance—Antimicrobial Stewardship and the CHARM Project

Benjamin Pontefract, PharmD, BCPS, Director of Research, CHARM; Assistant Professor, College of Pharmacy, Ferris State University

Point-of-care testing (POCT) provides unprecedented amounts information to outpatient healthcare practitioners. If used correctly, these tests can help reduce inappropriate antibiotic use by a substantial amount. In this talk, we will discuss how the appropriate use of POCTs can fuel antimicrobial stewardship efforts. We will also discuss the Collaboration to Harmonize AntiMicrobial Registry Measures (CHARM) project and how tracking antibiotic use is essentially to monitoring antimicrobial stewardship efforts.

Close of Summit3:15 pm