Point-of-care testing is a crucial component of healthcare both in an out of the clinical setting. Rapid care centers are now commonplace in many pharmacies and mobile diagnostics applications are allowing the consumer to take their health into their own hands. In addition to applications in infectious disease detection and antimicrobial stewardship, the field is opening up to include rapid molecular diagnostics in autoimmune diseases and cancer. Cambridge Healthtech Institute's Sixth Annual Point-of-Care Diagnostics symposium will examine how point of care is being used in the clinic, in pharmacies, and by the consumer. 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 23
7:00 am Registration and Morning Coffee
8:55 Chairperson’s Opening Remarks
Susan Kretz, MHA, MT(ASCP), Manager, Point-of-Care Testing, PCL Alverno Clinical Labs
9:00 Standardizing Point-of-Care for Two Large Hospital Systems, Can It Be Done?
Susan Kretz, MHA, MT(ASCP), Manager, Point-of-Care Testing, PCL Alverno Clinical Labs
In most hospital systems Point-of-Care testing is overseen by the hospital. What happens to POC when operation is taken under laboratory control? We will discuss why the lab was granted oversight and why standardization is important in POC testing. We will look at the process of how devices were evaluated/selected and discuss the challenges that were seen by moving two very different hospital systems to one POC test and device menu.
9:30 How to Generate Health Economic Claims for POC Testing
Katherine Tynan, Ph.D., Business Development & Strategic Consulting for Diagnostics Companies, Tynan Consulting LLC
Point-of-care testing for a variety of disease states provides an excellent opportunity for many providers to expand patient care services while improving health at the patient and population level. Measuring those improvements and tying them to quality metrics is key in the world where providers will be paid for quality not quantity. POC device developers are under increasing pressure to substantiate claims of cost reduction 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 traditional approaches will be discussed.
10:00 Three Essential Factors for Successful Development of a Microfluidic POC Diagnostic
Erol Harvey, Ph.D., CEO, MiniFAB
Three important factors for success of microfluidic POC diagnostics. Developments must be driven by user/market requirements. Devices must be designed with high integration and manufacturing simplicity. Representative integrated systems must be quickly achieved to facilitate assay testing and KOL feedback.
10:15 Designing for Humans in Point of Care Testing
Cece O’Connor, Global Director, UX Strategy & Design, Invetech
Successful POCT integration into health systems incorporates a deep knowledge of the people involved. Human-Centered Design Research uncovers powerful insights into user needs, leading to innovative, intuitive workflows and digital interactions. We will outline challenges faced with POCT design along with UX techniques to drive differentiated, streamlined experiences.
10:30 Coffee Break with Exhibit and Poster Viewing
11:15 The Trials and Tribulations of POCT: A Clinical Biochemist’s Perspective
Julie Shaw, Ph.D., Assistant Professor, Department of Pathology and Laboratory Medicine at The University of Ottawa - The Ottawa Hospital
This presentation will touch on practical challenges related to implementation of POCT. Specific challenges related to user compliance, order and result documentation, operator training and meeting accreditation requirements will be discussed.
11:45 Barriers to Point-of-Care HIV Testing - Evidence and Possible Solutions
Nitika Pant Pai, M.D., MPH, Ph.D., Associate Professor, Medicine, Divisions of Clinical Epidemiology & Infectious Diseases, McGill University
Point-of-care technologies offer a potential to expedite an initial screening/potential diagnosis, and/or clinical decisions at the point of clinical care. However, barriers at various levels exist and posing a challenge to their ideal implementation. Using data from field settings, this talk will provide an overview of the barriers at four levels- health systems, providers, patients and technologies. Some potential innovative solutions to facilitate the integration of POCTs in global health will also be presented.
12:15 pm Laser-Diodes: A Cost-Effective Step Up from LEDs
Henry Schek, Ph.D., Chief Technical Officer, Chroma Technology Corp
Laser-diodes are an under-utilized resource for achieving some of the best performance features of LEDs and costly lasers. We review a platform for flexible, custom, cost-effective, laser-diode sources for broad application in research, diagnostics and treatment.
12:30 Session Break
12:40 Luncheon Presentation: Handheld, Single Molecule Sensitive Diagnostic Platform
Dan Heller, CEO, Two Pore Guys, Inc.
Presenting technology and use cases for a handheld PoC testing platform using a saliva-to-results demonstration of HIV antibody test. 2PG's nanopore-based platform supports a broad menu of assays that can be adapted from existing reagents used on lab-based systems.
1:15 Session Break
1:50 Chairperson’s Remarks
Donald Klepser, Pharm.D., MBA, Associate Professor, Pharmacy Practice, University of Nebraska Medical Center
2:00 Telemedicine for Acute Care Diagnostics in Resource-Constrained Settings: A New Paradigm
Alfred Papali, M.D., Assistant Professor, Pulmonary & Critical Care Medicine, Institute for Global Health, University of Maryland School of Medicine
Low- and middle-income countries (LMICs) carry a substantial burden of critical illness worldwide, but material and human resource constraints in these environments often limit accurate diagnosis. Telemedicine is an emerging modality that can help to overcome these limitations. Novel telemedicine applications, combined with task shifting and point-of-care ultrasound, may help to improve acute care diagnostics in LMICs if scaled up as part of an organized, collaborative approach among diverse interests.
2:30 Lessons Learned in the Spread and Scale of Telehealth at Massachusetts General Hospital
Ronald Dixon, M.D., Director, Virtual Practice Project, Massachusetts General Hospital
With the aging of the population and the increasing burden of chronic disease, new models of health care delivery are required to achieve the triple aim of improving the experience of care, improving the health of populations, and reducing per capita costs of health care. POCT may have a role in all aspects of this triple aim, with widespread adoption being essential to success. This session will highlight five key lessons learned from the virtual healthcare sphere to ensure sustainable clinical adoption. Lessons learned include: expect failure and pivot creatively, iterate and adapt relentlessly, welcome collaborators as “co-conspirators”, embrace opposition, and provide continuous feedback.
3:00 Qorvo Biosensor Solution for Mobile and Point of Care Applications
Bryan Bothwell, Director, Strategy and Business Development, Qorvo
Qorvo has developed a biosensor platform to enable a paradigm shift in point of care (POC) testing. By combining multi-GHz bulk acoustic wave detection arrays with microfluidics and electronics integration, the platform delivers centralized lab results at the POC, breaking the technological barrier limiting ubiquitous deployment of liquid-based biosensors across all markets.
3:30 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall
4:15 Implementing Collaborative, Community Pharmacy-Based Disease Management Programs Using CLIA-Waived POC Tests
Donald Klepser, Pharm.D., MBA, Associate Professor, Pharmacy Practice, University of Nebraska Medical Center
CLIA-waived POCT can provide useful information to the pharmacist as part of collaborative disease management programs. Data from the successful implementation of such programs and the role of POCT in these programs will be discussed.
4:45 Pharmacist Point-of-Care Testing: A State Law Framework
Alex J. Adams, Pharm.D., MPH, Executive Director, Idaho State Board of Pharmacy
Presented by: Donald Klepser, Pharm.D., MBA, Associate Professor, Pharmacy Practice, University of Nebraska Medical Center
Pharmacists must navigate a complex maze of federal and state laws in order to fully engage in point-of-care testing. This session will discuss federal CLIA laws, state-level restrictions on CLIA-waived testing, and Collaborative Practice laws that enable pharmacists to act on the results of tests.
5:15 CLIA-Waived Cholesterol Point-of-Care Tests for Community Pharmacies
Deanna Tran, Pharm.D., BCACP, Assistant Professor, Pharmacy Practice and Science, University of Maryland School of Pharmacy
CLIA-waived cholesterol point-of-care tests are used in community pharmacies to assist with improving health outcomes of patients by providing health screenings and referring patients with dyslipidemia for further evaluation. Studies including pharmacists’ use of CLIA-waived cholesterol point-of-care devices and accuracy will be discussed.
5:45 Reception with Exhibit and Poster Viewing
6:45 Close of Day
Friday, February 24
7:00 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:00 Registration Open
8:25 Chairperson’s Remarks
Tharini Sathiamoorthy, Vice President, AdvaMedDx
8:30 Role of Pathogen Diagnostics in Antimicrobial Stewardship
Rangarajan Sampath, Ph.D., Senior Research Fellow and Senior Director, R&D, Ibis Biosciences, Abbott
The spread of multi-drug resistant organisms presents an increasing challenge to the management and treatment critical infections. Rapid and broad diagnostics are an unmet need. We describe a molecular method using PCR and electrospray ionization mass spectrometry (PCR/ESI-MS) that is capable of providing organism identifications for over 500 pathogens directly from patient specimens in less than 8 hours that has the potential to transform the way we use antimicrobials.
9:00 Influence of POC Testing on Antimicrobial Stewardship (AS) of Acute Exacerbation of Chronic Bronchitis (AECB) and Community-Acquired Pneumonia (CAP)
David Gilbert, M.D., Chief, Infectious Diseases, Providence Portland Medical Center
Increasing antibiotic resistance and a paltry pipeline of new, effective antibiotics is a crisis. Overuse of empiric antibiotics for respiratory tract infections is a major contributor to the problem. It is possible to reduce overuse by the POC use of multiplex PCR platforms to detect the presence of potential pathogens plus serum levels of procalcitonin. Procalcitonin levels can separate viral from bacterial infection and/or allow determination of whether detected bacteria are colonizing or invading. Two recent prospective studies will illustrate how this approach benefits AS.
9:30 Featured Poster: 30 Minute Phenotypic Antibiotic Susceptibility Test Directly from Clinical Samples
Travis Schlappi, Student, Chemical Engineering, California Institute of Technology
We used digital PCR (dPCR) to precisely measure DNA replication in bacteria exposed to antibiotics, and to shorten the required antibiotic exposure by allowing very high resolution quantification of DNA replication on timescales faster than cell division. Partitioning bacterial chromosomal DNA into many small volumes during dPCR enabled rapid AST via (i) precise quantification and (ii) a measure of how antibiotics affect the states of macromolecular assembly of bacterial chromosomes. This digital AST (dAST) determined susceptibility of clinical isolates from urinary tract infections (UTI) after 15 min of exposure for all four antibiotic classes relevant to UTIs. We then optimized the chemistries and performed the entire dAST workflow directly from clinical UTI samples in less than 30 min. This work lays a foundation for the development of a rapid, point-of-care AST that would improve patient outcomes and strengthen global antibiotic stewardship.
10:00 Panel with Session Speakers
10:30 Coffee Break with Exhibit and Poster Viewing
11:15 Point-of-Care Diagnostics for Personalized, Precision Dosing of Biologic Drugs
Bradley Messmer, Ph.D., CEO, Abreos Biosciences, Inc.
Biologic drugs have proven highly efficacious in the treatment of cancer and numerous chronic diseases, but they are also very costly. Despite evidence of a relationship between circulating drug levels and clinical efficacy for the majority of these drugs, dosing usually follows a one-dose-fits-all approach. Direct monitoring of drug levels in patient blood samples would enable precise, personalized dosing that can improve outcomes, minimize side effects, and reduce costs.
11:45 A Point-of-Care Platform for the Detection of Plasma Circulating microRNAs in the Low Resource Setting
Jorge Soto, CTO, Miroculus
Miroculus has developed a low-cost microRNA detection platform designed for laboratory technicians without specialized training and in a low-resource setting. The platform encompasses: a) a molecular assay capable of semi-quantitative reporting of miRNAs in biofluids, b) an instrument that fully automates the assay and minimizes user effort to simple deposition sample in a digital microfluidics cartridge inlet, c) real-time data analysis through cloud computing. The first application is stomach cancer detection.
12:15 pm Ultra Low-Cost, Portable Smartphone Optosensors for Mobile Point-of-Care Diagnostics
Lei Li, Ph.D., Assistant Professor, Mechanical and Materials Engineering, Washington State University
Optical biosensing in point-of-care (POC) diagnostics, including fluorescence, luminance, absorbance or colorimetric, has been widely accepted in almost every area of diagnostics/detection. Currently, high-performance optical elements are expensive and become a barrier for developing low-cost POC diagnostics. We have developed a serial of optosensing platforms that covers a wide range of applications. Especially, we have developed a low-cost miniaturized multichannel smartphone optosensing platform with high accuracy and sensitivity. Our unique optomechanical system design and manufacturing process made our platforms appropriate for low-cost in-field applications.
12:45 Close of Symposium