Cambridge Healthtech Institute’s Fifth Annual

Point-of-Care Diagnostics

Examining Rapid Diagnostics from Clinic to Consumer

March 10-11, 2016 | Hilton San Francisco Union Square | San Francisco, CA
Part of the 23rd International Molecular Medicine Tri-Conference


Point-of-care testing is becoming 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. Cambridge Healthtech Institute's Fifth 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.

Final Agenda

Thursday, March 10

7:30 am Registration and Morning Coffee


9:00 Chairperson’s Opening Remarks

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

9:10 The Inconvenient Truth about Near Patient Testing at the Doctor’s Office

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

Performing laboratory testing at the doctor’s office allows practitioners to provide immediate consultations. This could improve patient engagement and satisfaction. However, proper laboratory practice and regulatory compliance issues add a layer of complexity to the management of testing. In this presentation, we will look at a few examples to explore the good and the burden of near patient testing at the doctor’s office.

9:40 Save a Penny, Lose a Dollar: POC vs. Central Lab Testing in the Hospital Setting

Gyorgy Abel, M.D., Ph.D., Director, Clinical Chemistry and Molecular Diagnostics, Lahey Hospital & Medical Center

Clinical demand, convenience, and innovation are driving POCT worldwide. POCT is resource intensive and generally more expensive than central laboratory testing. As healthcare budgets get tighter and laboratory fee-for-service system is melting away with the emergence of Accountable Care Organizations (ACOs), the potential advantages of POCT must be thoroughly evaluated in the context of clinical benefit and costs. Health economics studies are needed to delineate areas where POCT is cost-effective.

10:10 Microfluidic-Enabled Sample Collection Strategies for PoC Diagnostics

Erol Harvey, Ph.D., CEO, MiniFAB

Microfluidic structures can simplify sample collection and cleanup, making the process more accurate and less prone to user error. Quantitative diagnostics usually require precise sample volumes, from nanolitres to microliters, and this can be achieved without skilled user input.

Biocartis10:25 IdyllaTM: Shaping the Future of Point of Impact Testing in Oncology and Infectious Diseases

Rudi Pauwels, CEO, Biocartis

10:40 Coffee Break with Exhibit and Poster Viewing


11:15 Shifting the Paradigm: Bringing Lab Services to the Corner Drugstore

Casey Kozlowski, RPh, MBA, Director, Diagnostic Testing Product Development, Walgreens

Pharmacists and pharmacies play a vital role in patient care. By marrying diagnostic testing with dispensing and adherence-based monitoring, we can improve patient health outcomes and lower overall healthcare costs.

11:45 Implementing Collaborative, Community Pharmacy-Based Disease Management Programs Using CLIA-Waived POC Tests

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

CLIA-waived POCT can provide useful information to the pharmacist as part of collaborative disease management programs. Data from the successful implementation of such progr ams and the role of POCT in these programs will be discussed.

12:15 pm Reimagining the Future of CLIA-Waivable Point-of-Care Molecular Diagnostics for Infectious Diseases

Dipankar Manna, Ph.D., Principal Scientist, LucigenDx

LucigenDx will describe a new platform designed to bring molecular diagnostics to point-of-care. The platform consists of a test cartridge and a compact instrument designed for CLIA-waiver. Sample prep, amplification and detection are performed by the isothermal amplification platform with no mixing or measuring. A clinical trial for is planned for 2016.

12:30 Session Break

12:40 Luncheon Presentation: POCT One-Step Molecular Diagnostic System Brings Complex Clinical Testing Directly to the Patient

Jesus Ching, Ph.D., CTO, Research & Development, Coyote Bioscience

Coyote Bioscience is dedicated to making break-through innovations in molecular diagnostics that bring complex clinical testing directly to the patient. We would like to introduce both of our lab-in-a-box instrumentation systems based on PCR technology and our novel method of one-step gene test without nucleic acids extraction.

1:15 Session Break


1:50 Chairperson’s Remarks

Casey Kozlowski, RPh, MBA, Director, Diagnostic Testing Product Development, Walgreens

2:00 The Future of Mobile Health: Closing the Health Loop

Jordan Shlain, M.D., Managing Partner, Private Medical; Chairman, HealthLoop

Doctors are being asked to do more with more but are not being given more time. Information is exploding, patients are getting empowered and doctors are struggling to keep up with all the innovation. Dr. Shlain will talk about how he built Healthloop from a simple idea: follow up. He will also discuss how mobile is on the precipice of transforming the medical experience.

2:30 Implications of Emerging Mobile Health Technologies in Preventative and Point-of-Care Diagnostics

Babette Gresko, Director, Mobile Engagement Technology and Population Health Management, Clinical Operations, HealthSignal Partners 

Mobile health technology has the potential to capture a variety of user health data, and help drive early care intervention. The challenges and potential solutions associated with unifying patient data through mobile health applications will be presented, and examples of how mobile health technology provides low cost risk and health management tools, involving patients and care givers, will be discussed.

3:00 Refreshment Break with Exhibit and Poster Viewing


3:30 Bringing Point-of-Care Testing to the “Internet of Things”

Pat Arensdorf, MBA, Principal, Halteres Associates, LLC

Bela T. Matyas, M.D., MPH, Health Officer and Deputy Director, Solano County Health Department

James Killeen, M.D., Clinical Director, Informatics Fellowship; Associate Director Information Services; Director, Beach Program, University of California San Diego Department of Emergency Medicine

Point-of-Care Testing (POCT) is poised to change the practice of medicine in many diverse settings worldwide, providing critical information needed during patient encounters. Enabled by advances in information and communications technologies, POCT results can now also be integrated with both clinical and community data in real time, informing not only individual patient care, but also ongoing population health initiatives, health system responses and resourcing plans. This presentation will focus on initial results from current studies in process to determine the impact of having diagnostic data available in real time for urgent care and public health settings.  It will also offer a compelling view of a wider role for POCT in an internet-connected healthcare environment.

4:30 Profound Need to Substantiate Health Economic Claims for POC Testing

Katherine Tynan, Ph.D., Tynan Consulting LLC

One of the major enablers of healthcare changes is the availability of more sophisticated point of care testing and monitoring devices. However 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 etc) through health economic modeling. Examples of how to demonstrate these claims to convince payers to favor POC diagnostics over more traditional approaches will be discussed.

5:00 Reception with Exhibit and Poster Viewing

6:00 Close of Day

Friday, March 11

8:00 am Morning Coffee


7:55 Chairperson’s Remarks

Gyorgy Abel, M.D., Ph.D., Director, Clinical Chemistry and Molecular Diagnostics, Lahey Hospital & Medical Center

mBioDiagnostics8:00 Innovative Plastic Waveguides Enable Fast, Low-Cost Multiplexing at the Point of Care

Chris Myatt, Founder & CEO, MBio Diagnostics

Optical waveguide sensors combined with fluorescent detection enable sensitive and highly multiplexed tests for point of care use. We will detail a simple disposable cartridge and portable reader design that permits scalable manufacturing while maintaining laboratory-quality performance. We will provide data from clinical studies run at more than a dozen sites worldwide, including an 88-feature proteomic array for tuberculosis, a blood-borne pathogen panel, and an isothermal molecular influenza test. This approach can open up new decentralized testing applications.

8:30 Polystyrene Plastics for Production of On-Demand Antibody Arrays for Point-of-Care Detection

Matthew A. Coleman, Ph.D., Physics and Life Sciences, BBTD, L-452, Lawrence Livermore National Laboratory

Inexpensive plastic biochips are being used as non-traditional alternatives to quantify data rapidly for medical diagnosis, drug development and discovery, and other biological research. We demonstrate that biochips made of polystyrene sheet (PS), commonly known as “Shrinky Dinks” for protein and antibody generation prior to biological detection. These PS devices are able to quantify protein and antibody interactions with 3-4 orders of detection sensitivity. Collectively, these results further expand the utility PS for use in point-of-care settings.

9:00 The Potential for Single Molecule Fluorescence Methods in Point-of-Care Technologies

Ted A. Laurence, Ph.D., Materials Science Division, Physics and Life Sciences, Lawrence Livermore National Laboratory

Single molecule fluorescence measurements at the interface of physics, chemistry and biology provide a new way to understand biological processes. We are developing single molecule-based methods for detection and monitoring of DNA and proteins in un-diluted biological samples. It is not often appreciated that, although technologically advanced, the basic techniques used are relatively simple and amenable to automation. With improved assays and miniaturization, these technologies have great potential to impact point-of-care.

9:30 Next-Generation Point-of-Care Testing: Clinical Needs, Technologies and Opportunities

Ping Wang, Ph.D., Director, Clinical Chemistry, Pathology and Genomic Medicine, Houston Methodist Hospital

Next-generation point-of-care diagnostic technologies are emerging, with potential applications of nanotechnology, microfluidics, sensors compatible with mobile phones and wearable electronics. The challenges lie in how to bridge these novel technologies with current clinical needs. This presentation will review current clinical needs from a clinician perspective, trends and promises of next-generation POCT, and discuss opportunities and strategies needed to realize these promises.

10:00 Rapid Diagnosis of Infectious Diseases at Point-of-Care

Anna Dixon, Ph.D., Research Manager, Research & Development, Atlas Genetics Limited

Atlas has developed an integrated system that can be deployed and used
at decentralised settings to identify nucleic acid targets from multiple sample
types in under 30 minutes. The io™ system performs all the steps of the assay from DNA extraction through to multiplex detection with no operator intervention following the addition of an unprocessed sample.

10:30 Coffee Break with Exhibit and Poster Viewing


11:00 Giving the Patient Power - Opening Pandora’s Box or Future Enlightenment?

Francis White, EU General Manager, AliveCor Ltd.

We have developed the AliveCor® Heart Monitor, a clinical-quality low-cost ECG recorder that records, displays, annotates, stores, and transfers single-channel electrocardiogram (ECG) rhythms wirelessly, using the ubiquitous smartphone. The device has US FDA approval, and is CE marked in Europe, available through leading retailers such as Amazon. The device has received an enthusiastic reception by users and has many presented and published clinical trial papers and abstracts that have demonstrated AliveCor’s usability, clinical accuracy, and ECG interpretation capabilities.

11:30 Lumify: App-Based Ultrasound on Your Own Compatible Android Smartdevice

Ajay Agarwal, Head, UltraMobile Product Mangement, Philips Healthcare

12:00 pm Biomarker-Based Diagnosis of Alzheimer’s Disease Using Acoustic Detection Techniques

Samantha Swarbrick, Ph.D. Student, Mechanical and Manufacturing Engineering, Loughborough University

Here we report feasibility studies for rapid detection of synthetic short single-stranded DNA sequences (ssDNA) in physiological buffer, which are a close model for microRNA, using complementary acoustic techniques. The sensitivity and selectivity of measurements with this entirely electronic technique suggest potential for a rapid and portable diagnostic for Alzheimer’s Disease, and in general for any biomarker-mediated clinical diagnostic.

12:30 Close of Symposium