Enabling Point-of-Care Diagnostics

Many countries around the world face the mounting challenges in healthcare with regard to escalating costs, managing antimicrobial drug resistance and providing increased patient access. Point-of-care technologies, which include wearable devices and sensors, remote monitoring and real-time analysis, provide innovative solutions that promise to improve treatment outcomes. Economic studies have demonstrated that point-of-care and rapid testing is cost-effective, but healthcare systems still need to adapt to take advantage of it and implement it where it makes sense. The ideal scenario would involve a closed-loop system where the rapid detection at the point-of-care, such as a doctor’s office, would provide and connect with a treatment regimen.

Scientific Advisory Board
Gyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Laboratory Medicine, Lahey Hospital & Medical Center
Holger Becker, Ph.D., Founder & CSO, microfluidic ChipShop GmbH
Eric van Gieson, Ph.D., Chief Technology Officer and Director of Research Strategy, National Strategic Research Institute



SC2: Method Validation According to CLSI Guidelines

SC5: Establishing the Value of Diagnostic Tests

*Separate registration required

7:30 am Main Conference Registration & Morning Coffee


8:30 Chairperson’s Opening Remarks

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

8:40 KEYNOTE PRESENTATION: Global Challenge of AMR and Importance of POC in the Fight

Debrah Boeras, Ph.D., Scientist and Consultant, The Global Health Impact Group, LLC

Diagnostics play a critical role in clinical decision making and disease control. Novel point-of-care (POC) tests that are highly accurate, easy to use and equipped with data transmission capacities can soon be deployed across all health care settings. In a digital age, linkage of data from diagnostic laboratories and POC testing sites can provide timely information on testing coverage, disease trends, and early warning of infectious disease outbreaks, thus increasing the efficiency of health care systems, and improving patient outcomes.

9:40 Global Perspective on Infectious Disease Testing with Point-of-Care Diagnostics

Gyorgy_AbelGyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Laboratory Medicine, Lahey Hospital & Medical Center

Innovative point-of-care molecular diagnostic platforms enable rapid and accurate identification of infectious disease pathogens, even in remote areas and resource-poor settings. Threatening, potentially global epidemics by the Ebola, MERS, Zika, Dengue and Chikungunya viruses, and the emergence of multi-drug-resistant "superbugs" world-wide demand for simple rapid molecular tests that can help determine optimal treatment, curb the spread of infections, and assist with allocation of resources. The presentation reviews clinical applications in diverse geographic and economic settings and discusses the related technologies.

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

11:00 A Molecular Diagnostic Platform For Point-of-Need Testing of Mosquito-Borne Diseases

John C. Carrano, Ph.D., President, Carrano Consulting, LLC

11:30 Using Informatics Solutions to Enable Appropriate and Compliant POC Testing

David McClintock, M.D., Medical Director, Pathology Informatics, Pathology, The University of Chicago Medicine

Point-of-care testing has traditionally been a manual, labor intensive process characterized by single use tests that do not readily interface with hospital and clinic information systems. Reliance on physicians, PAs, nurses, and other staff to accurately document the necessary order, result, quality control, and regulatory information required for each test can lead to patient safety, compliance, and billing errors. This talk will cover the current laboratory and regulatory challenges faced in point-of-care testing and how informatics solutions, both current and future, can help in hospital and clinic based practices.

GenePOC12:00 pm Enabling Molecular POCT - Beyond the Technology Driving Outcome

Patrice Allibert, Ph.D., CEO, Management, GenePOC

The need for actionable results has never been that expressed as today. The challenges healthcare providers are facing and the constant strive for increased efficiencies creates next to centralised non urgent (>4h TAT) Diagnostic testing a whole space for decentralised actionable (~ 1h TAT) diagnostic testing delivering actionable results at place of care impacting directly patient management.

12:30 Development of a Molecular HCV Assay on the Genedrive Point of Care Device

Gino Miele, Ph.D., Director, Research & Development, Epistem Ltd.

Genedrive® is a versatile, affordable and simple to use PCR based point of care device. This presentation will discuss the requirements and development of the Genedrive HCV viral detection assay which is targeted for use in high burden resource limited countries. Other adaptions of the Genedrive will also be discussed.

Invetech1:00 Luncheon Presentation: Why IVD Product Development Needs to Become Agile

Ludovic Labat, Ph.D., Global Vice President Sales, Diagnostics, Invetech

The IVD industry is increasingly challenged to deliver new instruments to market, while dealing with project delays, shrinking budgets and resource constraints. Learn how companies are adopting a new development paradigm to help teams respond to project unpredictability and result in reduced development costs and time to market.

1:30 Refreshment and Cookie Break in theExhibit Hall with Poster Viewing


2:00 Chairperson’s Remarks

 James V. Lawler, M.D., MPH CDR MC USN, ACESO Director, NMRC - Frederick

2:10 Building the Healthcare Internet of Things

Matthew_QuinnMatthew Quinn, MBA

Some estimate that by 2020, there will be 50B smart devices with 212B sensors generating 44 ZB of data. The Internet of Things or IoT holds great promise in transforming the way that we work and live. This presentation will describe the steps and challenges in building the broader IoT and how we can leverage it to support the creation of an interconnected collection of diagnostic platforms.

2:30 Wearable and Home-Based Sensors: Can They Improve Patient Outcomes?

Steve Steinhubl, M.D., Director, Digital Medicine, Scripps Translational Science Institute; Cardiologist, Scripps Clinic

Remarkable advances in miniaturized computing power and connectivity over the last several decades have changed nearly every aspect of our lives, but they have yet to make a substantial impact on healthcare. However, mobile health (mHealth) technologies currently being developed are capable of enabling unprecedented changes in the manner and quality of clinical care available to the growing majority of the world’s population with mobile connectivity.

2:50 Challenges in Developing the Next Generation of Diagnostics: The Role of Prizes

Erik_VirreErik Viirre, M.D., Ph.D., Adjunct Professor, UCSD Departments of Neurosciences, Surgery and Cognitive Sciences, Arthur C. Clarke Center and XPRIZE Foundation

The wide range of diagnostic sensors and analysis systems demands that the next generation will be integrated systems. The Qualcomm Tricorder XPRIZE was designed to spur the development of such integrated systems, with the demand that they be useable by consumers. The competition shows the great promise of these systems, but also the challenges to overcome for products that will actually be used. In this presentation the competition design will be used, some lessons learned from operation of the competition and what the future of sensor development, clinical trials, massive data management and regulatory review will look like.

3:10 Highly Versatile POC Diagnostic Devices

David_EckerDavid J. Ecker, Ph.D., Divisional Vice President and Carlsbad Site General Manager, Ibis Biosciences Inc., an Abbott Company

With increasing pressure on healthcare costs, point-of-care diagnostic devices need to deliver increasing value. No matter how hard you try, there is a minimum cost of materials to conduct a point-of-care molecular test, so absent a major breakthrough in technology we must look towards increasing the value of the result. I will describe a strategy for doing this.

3:35 Sample Collection Solutions for Successful Microfluidic PoC Diagnostics

Erol_HarveyErol Harvey, Ph.D., CEO, MiniFAB

Quantitative Point-of-Care diagnostics usually require precise sample volumes, from nanoliters to microliters, and often need to be performed without skilled user input. Microfluidic structures can simplify sample collection and clean-up making the process more accurate and less prone to user error.

3:50 Reimagining the Future of CLIA-Waivable Point-of-Care Molecular Diagnostics for Infectious Diseases

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

LucigenDx will update on the development of a point-of-care MDx platform designed for CLIA-waiver. The platform consists of an instrument and test cartridge allowing sample extraction, amplification and detection. Data will be presented on the planned C. difficile clinical trial.

4:05 Refreshment Break in the Exhibit Hall with Poster Viewing

4:50 PANEL DISCUSSION: Guiding Treatment with Instantaneous Diagnostic Results

  • Harnessing the “Internet of Things” movement to bring better connectivity between health care decisions and diagnostic results
  • Providing instantaneous diagnostic data to the care provider through the use of wearable diagnostics in settings where diagnostics were not available
  • Creating entirely new care bundles and protocols for sepsis and other acute diseases where instantaneous medical diagnostic data can have significant impacts on patient outcome

5:20 Innovative Point-of-Need Tools

Roberto_SpricigoRoberto Spricigo, Manager, Strategic Alliances & OEM, PON, QIAGEN Lake Constance

The point-of-care (POC) market is overloaded with instruments that are almost equivalent in their use, yet offer a very limited test menu. The presentation will highlight the need for a new universal open platform for a broad range of rapid tests.

5:35 Emerging Technologies for Next-Generation Microfluidics

Tom_TisoneTom Tisone, CEO, BioDot, Inc.

Microfluidics are increasingly more complex and focused on miniaturization. Fabrication of these devices requires reagent-dispensing approaches capable of delivering picoliter to microliter volumes. These systems must be compatible with a wide range of reagent classes and capable of producing millions of dispenses with a high level of precision and accuracy.

Slone Partners
 5:50 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing

6:50 Close of Day


7:15 am Registration

7:30 Problem-Solving Breakout Discussions with Continental Breakfast

Point-of-Care and Neurology

Erik Viirre, M.D., Ph.D., Adjunct Professor, UCSD Departments of Neurosciences, Surgery and Cognitive Sciences, Arthur C. Clarke Center and XPRIZE Foundation

  • What molecular indicators will be optimal for Strokes?
  • What Biophysical Indicators would be useful for POC Neuro assessment
  • What advanced technologies are coming in the next 5 years for Neuro assessment

How Necessary is Sequencing-based Diagnostics at the Point-of-Need?

Eric van Gieson, Ph.D., Chief Technology Officer and Director of Research Strategy, National Strategic Research Institute


  • How will it be accomplished and for what diseases?
  • For infectious disease, what is the better strategy: amplicon sequencing, shotgun, or assembly-based identification?
  • Is there value in point of care sequencing vs. array or multiplexed, amplification-based molecular diagnostics?
  • What is the most likely regulatory pathway to sequencing-based diagnostics for emerging infectious disease?


Microfluidic Devices: The Coming of Age of the Next Generation Diagnostic Devices

Christoph Mauracher, Ph.D., Managing Director, Sony DADC BioSciences GmbH

  • Past requirements
  • Current applications
  • Future possibilities


    8:25 Chairperson’s Remarks

    Bernard H. Weigl, Ph.D., Principal Investigator, Flow Based Diagnostics, Intellectual Ventures Management LLC

    8:30 3D-Printed Microfluidics for Point-of-Care Medicine

    Albert_FolchAlbert Folch, Ph.D., Associate Professor, Bioengineering, University of Washington

    Present technology for microfluidic device fabrication is based on plastic molding. However, molded devices are inherently limited by layered 2D designs, cannot be quickly disseminated from laboratory to bedside, and cannot be easily personalized to each patient. We are developing 3D-printing approaches that allow for custom fabrication of transparent, biocompatible 3D microfluidic devices. This microfluidic technology will be readily available via the web to biomedical scientists at very low cost.

    9:00 Micro Flow Cytometry: Automated Sample Prep Enabling A Broad POC Menu

    Dan_McPeakDan McPeak, Ph.D., Director, Microfluidics, Ativa Medical

    The clinical value of high-volume tests, such as CBC, is enhanced when coupled with commonly co-ordered, lower-volume assays. With a broad menu of tests available, POC practitioners would be better equipped to complete a diagnosis within the span of patient contact. This presentation discusses how Ativa Medical’s CBC technology creates opportunities for lower-volume, high-value cytometry assays at the point-of-care.

    9:30 High Performance Lateral Flow Assays

    Bernard_WeiglBernard H. Weigl, Ph.D., Principal Investigator, Flow Based Diagnostics, Intellectual Ventures Management LLC

    Immunochromatographic (or lateral flow) assays have long been the workhorse of diagnostics in global health settings. They are extremely low cost, easy to use, can be manufactured easily, and are available for the diagnosis of a number of infectious diseases that are common in developing countries. However, the format suffers from relatively low sensitivity, dynamic range, and generally is mostly used to provide qualitative answers. We present our work that aims to improve the platform across the board by making the format much more sensitive, quantitative, and usable for a much wider range of diagnostic analytes.

    10:00 Finally, a Point-of-Care Molecular System for the Physician’s Office

    Emily_Winn-DeenEmily Winn-Deen, Ph.D., Chief Strategy Officer, Mesa Biotech, Inc.

    Rapid and accurate identification of respiratory viruses is extremely important for accurate treatment of patients in outpatient physician office practices. Current CLIA-waived POC diagnostics either lack adequate sensitivity and/or specificity, or require relatively expensive instrument systems. Mesa Biotech has developed a rapid, easy-to-use, CLIA-waivable molecular diagnostic platform comprised of an inexpensive palm-sized, reusable dock and disposable test cartridges which together form a user-friendly system for use in the physician’s office and the urgent care clinic.

    10:30 Coffee Break in Exhibit Hall with Poster Viewing

    11:15 PLENARY KEYNOTE SESSION: Click here for details

    12:40 pm Luncheon Presentation: Point-of-Care Molecular Diagnostics Enable Better Testing Compliance and Immediate Patient Management Decisions

    Shana_KelleyShana Kelley, Founder & CTO, Xagenic Inc.

    Ihor_BoszkoIhor Boszko, Vice President, Business Development, Xagenic Inc.

    Recent availability of CLIA-waived molecular diagnostic tests has enabled improved patient care at a lower cost to the healthcare system. Xagenic is entering this rapidly growing market by commercializing a combination chlamydia/gonorrhea test, allowing better compliance with USPSTF and CDC screening recommendations. The Xagenic X1™ platform will permit in-office molecular testing in <20 minutes using non-refrigerated cartridges. We will produce a menu of multiplexed infectious disease tests with greatest utility during first clinical presentation.

    1:20 Close of Enabling Point-of-Care Diagnostics

    1:25 Ice Cream and Cookie Break in the Exhibit Hall with Poster Viewing