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.
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., R&D Director, Diagnostics and Biosurveillance, MRIGlobal
TUESDAY, AUGUST 18
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 Devices in the Real World – A Patient’s Perspective
Anna McCollister-Slipp, Co-Founder, Galileo Analytics
9:25 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.
9:40 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.
9:55 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.
11:30 PANEL DISCUSSION:
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).
Panelists:
Noam Ziv, Founder & CEO, Kesembe, Inc.
Donald Jones, CEO, Trial Fusion, Inc.
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
Anna McCollister-Slipp, Co-Founder, Galileo Analytics
Robert Matthews, Ph.D., CEO, NudgeWorX
12:30 pm Genedrive®- An Innovative Point-of-Care device for Rapid Disease Diagnosis and DNA Genotyping in Near Patient Settings
Peter Foster, Ph.D., Technical Director, Research and Development, Epistem Ltd.
Epistem’s Genedrive® portable PCR device enables the rapid diagnosis of disease and DNA genotyping in a Point of Care setting. Genedrive assays are low cost, simple to use and can be deployed in resource limited settings as well as near patient testing for companion diagnostics. Approval in India has been granted for the detection of Tuberculosis and antibiotic resistance. Tests for the detection and quantitation of viruses and companion diagnostic have also been developed.
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.
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3:35 Reimagining the Future of Point-of-Care Molecular Diagnostics for Infectious Disease
Hemanth Shenoi, Ph.D., Vice President, Business Development and Diagnostics, Lucigen Corp.
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
4:45 Smart Microfluidic and Its Impact on POC Diagnostics
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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
WEDNESDAY, AUGUST 19
7:15 am Registration
7:30 – 8:25 Problem-Solving Breakout Discussions with Continental Breakfast
These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.
Expanding The Diversity of Users and Increasing Use of the mHealth and Wearables – How Do We Do That?
Moderator: Andreas Caduff, Ph.D., CEO, Biovotion AG
- What is really required to arrive at truly value adding and sustainable offerings?
- Many of today’s offerings are designed for healthy, young and athletic people – what are the challenges to arrive at offerings for those that really need it?
- Is there going to be a one-size-fits-all type of technology or will we heavily need customised and group specific technology?
Hands-on Demonstration and Tour: Ambulatory ELFT Point-of-Care Testing*
Moderator: Mustapha S. Fofana, Ph.D., Associate Professor, Mechanical, Biomedical and Manufacturing Engineering, Worcester Polytechnic Institute
This discussion will review the following topics:
- Basic Mechanics for EFLT Point-of-care Testing
- SCORE Algorithms for ELFT Point-of-Care Testing
- System, Equipment, Analysis and Data Visualization
- Patient Health Information Library and Monitoring
- CAWOO Management for a Sustained Environment
- ELFT: E-Ebola, L-Lassa, F-Fever, T-Trace infections
- CAWOO: C-Contaminant, A-Agent, W-Waster, O-Odor, O-Organism
*Attendees can take breakfast to-go and will be directed outdoors for a hands-on ambulance demo
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.
10:00 Improving Patient Care through Decentralizing Molecular Diagnostic Tests for Infectious Diseases
John 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.
10:15 Manufacturing Innovation for POC Devices
Erol Harvey, Ph.D., CEO, miniFAB
Microfluidics has matured to a point where production volumes reach into the millions per annum, and products are achieving market success. This journey to maturity has included many lessons, such as understanding the division of function between consumable and re-usable components. Dr Harvey’s presentation will discuss key design and manufacturing principles that, when considered, optimize the chances of commercial success.
10:30 Coffee Break in Exhibit Hall with Poster Viewing
12:40 pm Luncheon Presentation: Empowering In-Office Treatment Decisions with Point-of-Care Molecular Diagnostic Testing
Shana Kelley, Ph.D., CTO, Xagenic Inc.
Ihor Boszko, Vice President, Business Development, Xagenic Inc.
Point-of-care MDx testing is finally available in 2015, and it unlocks a huge opportunity for improvement of clinical outcomes and reduction of healthcare costs by delivering better diagnostic tools for physicians. Xagenic has developed the enzyme-free, highly multiplexed Xagenic X1™ platform that boasts a time to result of 20 minutes with a low cost of adoption. Our strategy will bring to market a menu of infectious disease tests with greatest utility for clinical decision-making during the initial patient visit.
1:10 Close of Enabling Point-of-Care Diagnostics