Point-of-Care Diagnostics

Point-of-care diagnostic testing is currently a $16 billion market. Given its proven ability to increase efficiency, eliminate follow up visits, and save time and money, that value is estimated to grow to $36 billion by 2021 according to market reports. Cambridge Healthtech Institute's Seventh Annual Point-of-Care Diagnostics symposium will examine how point-of-care is being used in health systems, critical care, pharmacies, resource limited settings, and more.Point-of-care test developers and end users will address barriers to implementation and present solutions to encourage adoption. Finally, innovative point-of-care and mobile health technologies will be presented to showcase the latest tools and provide insights into the future of the field.

Thursday, February 15

7:00 am Registration Open and Morning Coffee

STANDARDIZING POCT ACROSS HOSPITAL AND HEALTH SYSTEMS

8:25 Chairperson’s Opening Remarks

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

8:30 Standardizing POCT Across Multi-Hospital Health Systems

Elsie_YuElsie Yu, Ph.D., DABCC, FACB, System Director, Chemistry, Toxicology and Point-of-Care Testing, Geisinger Medical Laboratories

With the increasing number of hospitals consolidations in North America, healthcare networks are becoming bigger, with more hospitals and clinics. Standardizing laboratory practice across all sites is an essential component in ensuring patient safety, patient satisfaction and efficient clinical operations. In this presentation, we will discuss the importance and challenges of standardizing POCT across a healthcare network.

9:00 POCT in Health Care Systems: Factors to Consider

Gyorgy_AbelGyorgy Abel, MD, PhD, Director, Molecular Diagnostics, & Clinical Chemistry/Immunology, Division of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, Massachusetts, United States

Challenges to system-wide standardization of POCT include: 1) diverse uses and utilization of POCT across the system in a variety of settings, 2) multiple technologies and equipment vendors, 3) various, coexisting EMR and LIS solutions, and 4) conflicting interests and opinions of key stakeholders. The talk reviews these challenges, offers examples, and an approach toward developing and implementing evidence-based, cost-effective solutions.

9:30 Developing Next Generation POC Diagnostics for Precision Medicine: Clinical Needs and Translation Opportunities

Ping_WangPing Wang, Ph.D., DABCC, FACB, Chief of Clinical Chemistry and Director of Core Laboratory Hospital of University of Pennsylvania

There is great potential for developing next generation POC diagnostic technologies to facilitate precision-based therapy and intervention. For these technologies to be successfully translated to clinical practice, they need to meet unmet clinical needs and demonstrate unique advantages. In this talk, I will cover needs in clinical diagnostics, some examples and translation opportunities being developed at Penn.

 

10:00 Top Tips for Successful Manufacture and Commercialization of Microfluidic Systems for MDx

Jason_HayesJason Hayes, Ph.D., Head, Product Development, MiniFAB
Product developers typically sit between a number of stakeholders, each with their own core requirements.  Hear some of the tips learned over the last 15 years in our role as a microfluidic product developer and manufacturer, translating molecular diagnostics systems to the market place.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

POC IN RESOURCE-CONSTRAINED CONDITIONS

11:15 Tele-Medicine and Point-of-Care Ultrasound: A New Paradigm for Resource-Constrained Settings

Andrea_LevineAndrea Levine, Fellow, Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh

Point-of-care ultrasound (POCUS) integrates into the tele-medicine infrastructure allowing bedside providers to obtain high quality, diagnostically relevant POCUS images guided by geographically removed ultrasound experts. This technology is prohibitively expensive in resource-limited countries. Video chat software available via smartphones, tablets, and other mobile computing devices can connect bedside providers with ultrasound experts around the globe transforming a technology ubiquitously carried in our pockets into a mobile tele-medicine platforms usable worldwide.

11:45 Evolution of Far-Forward Infectious Diseases Detection and Diagnostic Devices Used by the U.S. Military in Resource-Constrained Environments

Russell_ColemanRussell E. Coleman, Senior Market Manager (Medical/CBRN), Battelle Memorial Institute

U.S. military personnel deploy world-wide where they may be exposed to a variety of naturally occurring and intentionally disseminated infectious agents that can impact military operations. As a result, the military has a long history developing field-deployable diagnostics. In this presentation, COL (Retired) Coleman will provide an overview of factors affecting the development and deployment of diagnostic devices during military deployments over the past 25 years.

12:15 pm Optimizing Illumination for Fluorescence Diagnostics

Henry Schek, Ph.D., CTO, Chroma Technology Corp.

Efficient design and performance of fluorescence assays in POC devices requires a holistic approach to the integration of both illumination and detection systems, however, illumination and optical filtering of excitation light are often considered late in the design process. Dr. Schek will review illumination considerations for the cost and performance of POC fluorescent assays focusing on laser-based options that were formerly cost-prohibitive.


12:30 Session Break

12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Session Break

POC IN PHARMACY SETTINGS

1:55 Chairperson’s Remarks

Donald Klepser, Pharm.D., MBA, Associate Professor and Vice Chair, Department of Pharmacy Practice, College of Pharmacy, University of Nebraska Medical Center

2:00 Implementing Collaborative, Community Pharmacy-Based Disease Management Programs Using CLIA-Waived POC Tests

Donald_KlepserDonald Klepser, Pharm.D., MBA, Associate Professor and Vice Chair, Department of Pharmacy Practice, College of Pharmacy, University of Nebraska Medical Center

Community pharmacies have a long but limited history of providing CLIA-waived point-of-care testing (POCT) services. Much of the testing has taken place as part of small research or pilot programs. Based on the success of the pilots, pharmacies are expanding these services to a larger number of stores. This session will describe the current landscape of pharmacy-based POCT and the challenges of moving from a pilot to a sustainable service.

2:30 The Practical Implementation of Pharmacogenetics in Community Pharmacy

Olivia_BentleyAmina Abubakar, PharmD, AAHIVP – Owner/CE, Rx Clinic Pharmacy

Learn from community pharmacists providing innovative clinical services such as pharmacogenetic testing. The lead pharmacists of the Pharmacogenetics Centers of Excellence will share successful business models that incorporate best practices for the clinical application and implementation and their journey on how they making pharmacogenetic testing in a community and ambulatory care setting a reality.

3:00 Qorvo Biotechnologies Novel Platform for Point of Need Applications

Bryan_BothwellBryan Bothwell, Director, Strategy and Business Development, Qorvo Biotechnologies

Qorvo Biotechnologies has developed a biosensor platform that creates a paradigm shift in point of need testing. By combining novel multi-GHz bulk acoustic wave detection arrays with microfluidics and electronics integration, centralized lab results at the true point of need are enabled- breaking the technological barrier limiting ubiquitous deployment of liquid-based biosensors across all markets. Sample flexibility and performance across both Immunoassays and Molecular Dx make this a truly universal platform.

3:30 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall

4:15 Use of CLIA-Waived POCT to Support Outpatient Antimicrobial Stewardship

Michael_KlepserMichael E. Klepser, Pharm.D., FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy

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.

4:45 Rapid, Real-Time Infectious Disease Detection and Antibiotic Susceptibility Testing Directly from Positive Blood Cultures Using Novel CMOS-Based Electrical Biosensors

Oren_KnopfmacherOren Knopfmacher, Ph.D., CEO, Avails Medical

Appropriate real-time antibiotic therapy is critical in the management of severe sepsis and septic shock to reduce mortality, morbidity and health costs. Avails CMOS-based biosensor technology shortcuts cumbersome microbial subcultures. It allows for the first-time rapid pathogen quantification and multiplexed antibiotic susceptibility testing directly from a positive blood culture, in real-time, cutting diagnosis time from days to hours.

5:15 Analytical Testing Opportunities to Support Autologous Gene Therapy

Chaminda_SalgadoChaminda Salgado, Ph.D., Scientific Leader, Cell & Gene Therapies, GlaxoSmithKline

Autologous gene therapies require a paradigm shift change in QC analytics, with a degree of sophistication-only pursued by the Point-of-Care Diagnostic sector. This presentation highlights a new market opportunity for those willing to consider expanding the existing capabilities of their instrumentation. Doing so will provide a faster route to market due to the lower regulatory barriers to overcome, compared to the IVD sector.

5:45 Reception in the Exhibit Hall with Poster Viewing

6:45 Close of Day

Friday, February 16

8:00 am Registration Open and Morning Coffee

EMERGING POC TECHNOLOGIES AND APPROACHES

8:25 Chairperson’s Remarks

Katherine Tynan, Ph.D., Tynan Consulting LLC

8:30 Medical Tricorders — Taking Science Fiction into Reality (Hint: Winning the XPRIZE Is Just the First Step!)

Philip_CharronPhilip Charron, Head of Experience Design, Basil Leaf Technologies

In April, 2017, our home-grown team of seven won the Qualcomm Tricorder XPRIZE competition against 311 other teams. The challenge was to create a consumer device that continuously tracks five vital signs, diagnoses 13 medical conditions, weighs under 5 lbs, and receives high usability scores from a group of test users. We will discuss our data-oriented approach to our work and how critical user experience was to our success.

9:00 Point-of-Care Devices to Transform Sepsis Care

Bobby_ReddyBobby Reddy Jr., Ph.D., CEO, Prenosis

Point-of-care (POC) products, sensors that enable the collection of information regarding a patient’s health state in convenient locations in a timely fashion, provide significant value in many healthcare settings. Because of the lack of specific anti-sepsis treatments available today, most successful management strategies depend on early recognition of potential cases and subsequent swift therapeutic response. In this talk, we will describe the current state of POC sensors for sepsis diagnosis/monitoring and outline many exciting opportunities for these devices.

9:30 Low-Cost Bioelectronic Detection of Microbes: A New Generation of Fast, Cheap, Accurate Diagnostics

Lisa_DiamondLisa Diamond, CEO, Pinpoint Diagnostics, Pinpoint Science LLC

Pinpoint Science is building novel diagnostics based on functionalized nanopipettes developed by Dr. Nader Pourmand, professor of biomolecular engineering at University of California, Santa Cruz. In seconds, tests using this new technology can detect pathogens - viral, bacterial or fungal-with a simple, handheld device and disposable cartridges. Accurate, instant point-of-care results with no lab, no technicians, no refrigeration, no sample prep.

 Two Pore Guys 10:00 Handheld, Single-Molecule Sensing Platform

Dan HellerDan Heller, CEO and Co-founder, Two Pore Guys, Inc.

Two Pore Guys (2PG) has developed a handheld, single-molecule sensing platform with sample-to-result capability. It can detect nucleic acids and protein targets from human, animal, agriculture, and environmental samples. The development platform accepts third party reagents, including those already developed for centralized lab equipment. More information is available at twoporeguys.com.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

REIMBURSEMENT AND DEMONSTRATING ECONOMIC VALUE

11:15 Health Economics for POC Testing “the Good, the Bad, and the Ugly”

Katherine_TynanKatherine Tynan, Ph.D., Tynan Consulting LLC

Device developers are under increasing pressure to substantiate claims of cost reduction or equivalence through increased efficiency (reduction in testing & clinical visits, improvement in work flows, reduction in prescriptions for antibiotics, etc.) through health economic modeling. Examples of how to demonstrate these claims to convince stakeholders/payers to favor POC diagnostics over more central lab approaches will be discussed.

11:45 Demonstrating Economic Value of POC Diagnostics

Dwight Denham, MBA, Vice President, Global Health Economics & Reimbursement, Danaher Corp., Diagnostics & Life Science Platforms

 


12:15 pm POC Adoption of Molecular Infectious Disease Testing within an Integrated Healthcare Delivery Network

Diana Hernandez, Ph.D., Research Director, Clinical Microbiology, Geisinger Health System

While it is true that there is ambiguity within the reimbursement landscape, in most cases, the lack of reimbursement in our industry is the result of self-inflicted wounds. Payors have made it clear what industry must do to get paid and the industry continues to ignore what they hear.

12:45 Close of Symposium

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