2015 Next Generation Dx Summit

Cambridge Healthtech Institute’s Ninth Annual
Enabling Point-of-Care Diagnostics
Impacting Patient Care
August 18-19, 2015 | Capital Hilton | Washington, DC

Rapid point-of-care testing is branching out and finding applications in a multitude of settings. This year, we will explore wearable and home use technologies, cell-based devices, ambulatory testing for infectious disease including Ebola virus, integrated diagnostic and treatment devices and point-of-care assays for antibiotic resistance. This meeting is the preeminent source for industry, research and clinical community and is influencing the course of adoption. Join us in DC this August to stay up to date on point-of-care diagnostics and utility in the clinic for impacting patient care.

Day 1 | Day 2 | Short Courses | Download Brochure 


7:30 am Main Conference Registration & Morning Coffee


8:30 Chairperson’s Opening Remarks

Eric van Gieson, Ph.D., Director, R&D, Diagnostics and Biosurveillance, MRIGlobal

8:40 KEYNOTE PRESENTATION: A Bionic Pancreas for Automated Type 1 Diabetes Management

Edward R. Damiano, Ph.D., Professor, Biomedical Engineering, Boston University

We have developed a bionic pancreas for automated management of type 1 diabetes. The device consists of a continuous glucose monitor, subcutaneous infusion pumps to deliver insulin and glucagon, and an iPhone, which executes mathematical algorithms that determine the precise amount of insulin and glucagon to deliver. Results of our outpatient clinical trials testing the system in people with type 1 diabetes will be presented.

9:10 Wearable Diagnostics in Clinical Practice

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

In experiments our group previously conducted at USAMRIID, analysis of telemetry signals of vital signs and cardiac electrical activity was able to identify fatal cases of Ebola-challenged primates prior to the development of symptoms. Exploiting real-time physiologic signals could greatly expand providers’ insight into patient health over time and potentially identify acute illness. The growing availability of personal monitoring devices, such as FitBit, are revolutionizing the fitness world but have yet to be incorporated into daily medical practice. This will inevitably change. Real-time and continuous monitoring will have a profound impact on future medical practice.

9:25 Wearable Technology for Threat Awareness

Christian Whitchurch, Manager, Detection, Diagnostics & Biosurveillance, Defense Threat Reduction Agency (DTRA)

Two very interesting fields of technology are converging: wearable technologies for health monitoring, and biomarker discovery for exposure/infection. Progress in these fields predicts the development of a wear-and-forget, host-based sensor suite that continually monitors the soldier/doctor/first responder for signs of infection or exposure to chemical or biological hazards. If realized, this could be a hugely enabling technology for the warfighter, the first responder, healthcare workers, BSL4 staff, and others.

9:40 Quantified Self and the Future of Diagnostics

Maarten den Braber, MSc, Co-Founder, Quantified Self Europe

The convergence and exponential developments of technology puts power in the hands of individuals that was previously not available at all, or restricted to labs or other capital-intensive owners. Quantified Self is a world-wide community of people working on research for n=1. What does that mean for current organizations and the quality of our health? This presentation will feature many examples, scenarios, demos and room for discussion.

9:55 A Next-Generation Wearable Physiological Monitoring System

Andreas Caduff, Ph.D., CEO, Biovotion AG

Wearables and wearable monitoring along with digital health or mHealth are often heard terms these days. But what will need to be done to make such solutions sustainable offerings that have the potential to be used over a longer period of time? What will really need to be offered to allow for truly added value that succeeds to outweigh often seen inconveniences? This talk will illustrate relevant elements and considerations to arrive at value creating offerings.

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

11:00 The rHEALTH Technology for Universal Biomedical Diagnosis

Eugene Chan, M.D., Founder, CEO, DNA Medicine Institute

We have developed the rHEALTH technology for measurement of many laboratory tests off a single drop of blood. To date, the technology has been demonstrated on over 22 tests, many of which against FDA gold-standards. These include blood counts, chemistry, biomarkers, small molecules, and vital signs. The rHEALTH technology is designed to empower individuals and professionals to get as much access to individual biomedical information as possible.

11:15 Science Fiction Becoming a Reality

Grant R. Campany, Senior Director & Prize Lead, Qualcomm Tricorder XPRIZE & Nokia Sensing XCHALLENGE

In the fictional TV/movie series Star Trek, Captain Kirk talks to his crew via a communicator, has his medical officers assess conditions through a handheld tricorder, and synthesizes food and physical goods using his replicator. This, of course, is science fiction, however, in some cases it is becoming science reality. Many of the technologies that we saw in Star Trek are actually beginning to materialize. Captain Kirk’s communicator could be seen as inspiration for today’s smartphones, 3D printing could be compared to Star Trek’s replicator, and most recently, the $10M Qualcomm Tricorder XPRIZE is challenging teams to develop a mobile device capable of giving consumers access to diagnostic tools that deliver meaningful information about their health status.



Moderator: Eric van Gieson, Ph.D., R&D Director, Diagnostics and Biosurveillance, MRIGlobal

Participants will discuss the steps necessary to extract diagnostic value from wearable monitoring systems and home-use diagnostic applications, given that most products destined for home-use are not able to provide specific diagnosis or provide early warning of potential disease onset. The discussion will center on reliability, regulatory hurdles that need to be overcome, and the likelihood of user adoption (how to engage users through a positive user experience and perception of utility).


Noam Ziv, Founder & CEO, Kesembe, Inc.

Donald Jones, CEO, Trial Fusion, Inc.

Erik Viirre, M.D., Ph.D., Adjunct Professor, Neuroscience, University of California, San Diego; Surgery and Cognitive Science, Arthur C. Clarke Center and XPRIZE Foundation

Matthew C. Lorence, Ph.D., Executive Vice President, Marketing and Sales, Edge Biosystems, Inc.

Edward R. Damiano, Ph.D., Associate Professor, Biomedical Engineering, Boston University

Epistem12:30 Presentation to be Announced

Invetech(1)1:00 Luncheon Presentation: Designing Point-of-Care Instruments: Challenges and Proven Tools for Success    

David James, Senior Vice President, Diagnostics, Invetech
Developing market-leading instruments and consumables to meet the demanding requirements for point-of-care requires specialist skills and experience. Stakeholders with competing priorities are often challenged to find a method to agree on the “critical few” requirements that will provide the best product solutions. In this session we discuss proven tools and processes critical to defining a winning design and then delivering a robust and competitive final product in the shortest time to market. 

1:30 Refreshment Break in the Exhibit Hall with Poster Viewing


2:00 Chairperson’s Remarks

Holger Becker, Ph.D., Founder & CSO, microfluidic ChipShop GmbH

2:05 Point-of-Care Diagnostics for Clinical Hematology: Towards Novel Cell-Based Hemostasis Assays and Patient-Operated Self-Tests

Wilbur A. Lam, M.D., Ph.D., Assistant Professor, Pediatrics and Biomedical Engineering, Emory University and Georgia Institute of Technology

Hematologic disorders, almost by definition, can be diagnosed via sampling and analysis of blood and as such, are especially amenable for point-of-care and cell-based diagnosis. In this presentation, newly developed microfluidic cell-based assays for assessing hemostatic function that offer improvements over standard clinical tests will be described. In addition, a clinical assessment of a recently developed patient-operated, disposable, self-test for anemia will also be discussed.

2:35 POC Diagnostics – A New Era for Portable Devices

James F. Leary, Ph.D., Professor, Basic Medical Sciences & Biomedical Engineering, Purdue University

Portable devices required evolution of new technologies (e.g. low-power LEDs, nanophotonic sensors, “smart-nanoparticles”) that permit small, light-weight, low-power instruments to be brought to the patient. This represents a fundamental paradigm shift in medicine changing the way healthcare decisions can be made. If rapid tests can be made within 15-20 minutes, important medical decisions can be made during an initial patient visit to improve patient outcomes.

3:05 Cell-Based Microfluidic Assays for Cardiovascular and Ocular Diagnostics

Shashi K. Murthy, Ph.D., Associate Professor, Chemical Engineering, Northeastern University

Cell-based microfluidic assays have advanced significantly, particularly in targeting circulating tumor cells. The mode of operation of such assays is typically target cell identification followed by enumeration. However, it is now possible to leverage cellular function to obtain diagnostic readouts. This presentation will describe examples of both current generation and next generation cell-based microfluidic diagnostic assays in the context of cardiovascular and ocular diagnostics, respectively.

Lucigen Diagnostics3:35 Reimagining the Future of Point-of-Care Molecular Diagnostics for Infectious Disease 

Hemanth Shenoi, Ph.D., Director, Business Development, Lucigen

Lucigen is developing ClariLight™, a CLIA-waivable molecular diagnostic platform that provides results in about 30 minutes. The simple format will be usable by laboratory and non-laboratory health care staff to accurately diagnose infectious diseases at the point-of-care. Our initial focus is hospital-acquired infections, specifically Clostridium difficile infection. This presentation will describe the patented isothermal amplification technology, pre-clinical data and plans for a dual 510(k) and CLIA-waiver clinical trial.

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


FUNAI4:45 Smart Microfluidic and Its Impact on POC Diagnostics 

Yimin Guan, Ph.D, Microfluidic Business Development, Funai TSG Group

Funai, a leader in inkjet technology innovation, has developed novel microfluidic modules based on MEMS process of thermal inkjet technology, which include on-chip pico pump, mixer, filter and output jetting array. Fabricated by using standard semiconductor process and with built-in CMOS control, the modules are low-cost, small, intelligent and ready for mass production. The integration of these intelligent, low-cost modules will enable various new POC diagnostic platforms.

5:00 Ultrasensitive Rare Cell Disease Diagnostics on Hybrid Microfluidic/Microelectronic Chips

David Issadore, Ph.D., Assistant Professor, Bioengineering and Electrical Engineering, University of Pennsylvania

The impact of the growth in microelectronics has been profound - computing is pervasive and portable, communication is instant and global, and information is ubiquitously gathered and shared. My research aims to harness these same electrical engineering approaches, which have enabled the microelectronic revolution, to solve high impact problems in medical diagnostics. To accomplish this goal my lab develops hybrid microchips, where microfluidics (i.e. micrometer sized plumbing) are built directly on top of semiconductor chips.

5:25 Low Cost, Non-Invasive, Onsite Paper-Based Multiplex Device for Early Prediction of Kidney Damage

Kadamb Patel, Ph.D., Program Manager, Biosensor, Research Scientist, Centre of Molecular Diagnostics, School of Applied Science, Temasek Polytechnic

We have developed simple, user-friendly, inexpensive, noninvasive, and accurate, low cost, point-of-care paper-based multiplex device for early prediction of kidney damage. Paper-based device was developed using selected urine biomarkers with high sensitivity and specificity, namely the Kidney injury molecule-1 (KIM-1) and Neutrophil gelatinase-associated lipocalin (NGAL) which can be used for early prediction of acute kidney injury.

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

6:50 Close of Day

Day 1 | Day 2 | Short Courses | Download Brochure 


7:15 am Registration

7:30 – 8:25 Problem-Solving Breakout Discussions with Continental Breakfast


8:25 Chairperson’s Opening Remarks

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

8:30 KEYNOTE PRESENTATION: Coming to a Lab Near You: Global Review of POCT

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

Clinical demand, convenience, and technological advancements have contributed to the increasing popularity of point-of-care testing (POCT) world-wide. Yet there are considerable differences in the utilization of POCT depending on the different medical needs, health care delivery and reimbursement systems in various countries. The presentation reviews these differences, the key drivers, challenges, trends, and the attitudes toward POCT by geographic/economic region.

9:00 Use of a POC Laboratory to Successfully Manage Ebola Patients

James C. Ritchie, Ph.D., Medical Director & Professor, Pathology & Laboratory Medicine, Emory University

Our hospital has successfully treated 4 Ebola patients. These patients were entirely managed using laboratory values generated by a point-of-care testing laboratory located within the treatment unit. We will discuss the instrumentation used, the staff preparation, and the teamwork needed to make this approach viable. We will also briefly discuss the results for the common chemistry analytes on these patients throughout their treatment course. Finally we will discuss the shipping of specimens and decontamination of equipment and the laboratory after the patients depart.

9:30 Ambulatory POCT for Ebola, Lassa, Fever and Trace Infections

Mustapha S. Fofana, Ph.D., Associate Professor, Mechanical, Biomedical and Manufacturing Engineering, Worcester Polytechnic Institute

The Ambulatory Point-of-Care Testing (POCT) vehicles are designed for rapid verification of people suspected of Ebola, Lassa, Fever and Trace (ELFT) infections. We will discuss the basic mechanics for POCT, explain engineering innovations of the POCT vehicles, outline new approach of POCT for ELFT infections, discuss safety topics related to renewable standards for evaluating and treating ELFT patients.

Atlas Genetics10:00 Improving Patient Care through Decentralizing Molecular Diagnostic Tests for Infectious Diseases 

John ClarksonJohn Clarkson, Ph.D., CEO, Atlas Genetics Ltd.

Diagnostic test accuracy and turn-around time are vital characteristics in the fight against infectious diseases. Decentralizing diagnostic tests to the doctors’ office, specialist clinics or hospital ER can improve response time and increase test coverage of the population. In this presentation, attendees will gain an understanding of recent developments in decentralized diagnostics and what aspects of the system specification will drive clinical uptake.

MiniFab10:15 Manufacturing Innovation for POC Devices

Erol Harvey, CEO, miniFAB

10:30 Coffee Break in Exhibit Hall with Poster Viewing

PLENARY KEYNOTE SESSION: Click here for details 

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

1:10 Close of Enabling Point-of-Care Diagnostics

Day 1 | Day 2 | Short Courses | Download Brochure 

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2015 Brochure


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