Point-of-Care testing is one of the fastest-growing segments of the IVD market, with fifteen percent growth projected. Rapid testing can be used for clinical decision making to deliver an improved turnaround time and quality of care. Advances are changing the current treatment paradigm for cardiac, HIV, influenza, and a spectrum of infectious disease testing. Hear the experts discuss all aspects of the field, including technology, integration, adoption, clinical impact, regulatory approval and reimbursement.
Scientific Advisory Board
Gyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Department of Laboratory Medicine, Lahey Clinic Medical Center
Chong H. Ahn, Ph.D., Mitchell P. Kartalia Chair and Professor, Microsystems and BioMEMS Laboratory, School of Electronics and Computing Systems, University of Cincinnati
Matthew Lorence, Ph.D., M.B.A., Principal, Halteres Associates
Harry Glorikian, Healthcare Consultant
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TUESDAY, AUGUST 19
7:30 am Main Conference Registration & Morning Coffee
8:30 Chairperson’s Opening Remarks
Matthew Lorence, Ph.D., MBA, Executive Vice President, Marketing and Sales, Edge Biosystems, Inc.
8:40 Point-of-Care Diagnostics: Regulatory Perspective
Pawan K. Jain, M.D., Ph.D., Senior Regulatory Scientist, Division of Emerging and Transfusion Transmitted Disease, Office of Blood Research and Review, Center for Biologics Evaluation Research, FDA
CBER at FDA reviews the HIV diagnostic devices. The approved point-of-care devices for aid in diagnosis of HIV are being presented from the perspective of regulations and performance characteristics.
9:00 Moderator: Matthew Lorence, Ph.D., MBA, Executive Vice President, Marketing and Sales, Edge Biosystems, Inc.
Advancements in diagnostics technologies and communications are driving increased interest in delivering diagnostic solutions for resource limited settings (RLS). Diagnostics for RLS can be developed more effectively through the establishment of product, regulatory and business standards. This panel will discuss the opportunities for cost-effective POC diagnostics in RLS and current efforts to establish standards to develop POC diagnostics for the global health market.
John C. Carrano, Ph.D., President and Founder, Paratus Diagnostics, LLC
George M. Whitesides, Ph.D., Woodford L. & Ann A. Flowers Professor, Chemistry & Chemical Biology, Harvard University
Randy Allen, Ph.D., Director, Global Markets Team, Clinton Health Access Initiative (CHAI)
Pawan K. Jain, M.D., Ph.D., Senior Regulatory Scientist, CBER/OBRR/DETTD/PRB/FDA
Eric van Gieson, Ph.D., R&D Director, Diagnostics and Biosurveillance, MRIGlobal
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
10:55 Chairperson’s Remarks
Gyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Laboratory Medicine, Lahey Hospital & Medical Center
11:00 A Handheld Point-of-Care Medical Tricorder and Wearable Lab-on-a-Chip System Based on Novel Microfluidics
Zhenyu Li, Ph.D., Assistant Professor, School of Engineering and Applied Science, George Washington University
Co-Presenter: Baabi Das, MBA, President and Founder, Zansors
Recent microfluidic technology developments in the laboratories of George Washington University and commercialized by Zansors offer next-generation tools for realizing both medical tricorder-like handheld in vitro diagnostic (IVD) systems and wearable lab-on-a-chip systems. A fully automated handheld immunoassay system will be discussed as well as a bendable, stretchable microfluidic system based on oxidative stress and other biomarkers.
11:30 Technological Advances in Point-of-Care Diabetes Diagnosis and Management
Asad R. Zaidi, President & CEO, Epinex Diagnostics, Inc.
Analysis of the current status and potential impact of POCT on the diabetic and prediabetic population, changing healthcare guidelines, and patient outcomes. Includes a discussion on the latest, up and coming technologies, test markers, and testing systems and how these can change healthcare delivery and outcomes for millions of diabetics worldwide.
12:00 pm Utilizing High Sensitive Troponin I Assay in the Emergency Department
Shahriar Dadkhah, M.D., MBA, FACC, FSCAI, Associate Professor, Medicine, University of Illinois; Director, Cardiology Research, Saint Francis Hospital
12:30 Genedrive®: A Major Advance in Molecular Diagnostic Testing of Infectious Disease in POC Settings
Matthew Walls, CEO, Epistem Plc
Genedrive® is targeting a major advance in molecular diagnostic testing by providing a rapid, low cost, simple to use 'Point of Care' device with high sensitivity and specificity for use in diagnosis of infectious diseases and companion diagnostics. The first infectious disease assay for launch on Genedrive® is in Tuberculosis (TB) and aims to set a 'new standard' for the testing of TB & antibiotic resistance in low resource settings.
1:00 Luncheon Presentation I: What Do Point-of-Care
Product Developers Need to Know—Advice from the Field
Judy Macemon, Director, Marketing, invetech Diagnostics
Marjorie Toth, Program Manager, Invetech Diagnostics
Development of point-of-care (POC) products presents a range of challenges at every stage from initial concept and design through to launch. This session will provide field-proven strategies to address the risks and roadblock in the product development process in order to improve the chances of commercial success. Through working on more than 30 different POC projects, real-world insights will be provided on how to balance market needs with quality, performance and costs factors.
1:30 Luncheon Presentation II: (Sponsorship Opportunity Available)
2:00 Session Break
2:15 Chairperson’s Remarks
Holger Becker, Ph.D., Founder & CSO, microfluidic ChipShop GmbHx
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2:20 Next-Generation Imaging and Diagnostics through Mobile Phones
Aydogan Ozcan, Ph.D., Chancellor’s Professor, Electrical Engineering and Bioengineering, University of California Los Angeles; Associate Director, California NanoSystems Institute (CNSI)
As computational resources are becoming more powerful, while getting cheaper and more widely available, traditional imaging, sensing and diagnostic tools will continue to experience a revolution. We will summarize our recent work on emerging computational imaging, sensing and diagnostics techniques that utilize mobile phones to potentially transform the delivery of health care globally.
2:50 Smartphone-Based Lab-on-a-Chip Diagnostics
David Erickson, Ph.D., Associate Professor, Sibley School of Mechanical & Aerospace Engineering, Cornell University
In this talk I will discuss the transformative opportunity for the use of smartphone based technology in lab-on-a-chip diagnostics. Applications will focus on nutrition monitoring and cancer diagnostics in limited resource settings.
3:20 Moving Molecular Diagnostics for Infectious Diseases to Point-of-Care
Hemanth Shenoi, Ph.D., Director, Business Development, Lucigen Corporation
Point-of-care testing can lower cost and improve healthcare outcomes; however molecular diagnostic tests are currently not available at POC. Through a case study example, attendees will gain an understanding of the product development and regulatory approval path for a CLIA-waivable molecular diagnostic point of care test platform.
3:35 Sponsored Presentation (Opportunity Available)
3:50 Refreshment Break in the Exhibit Hall with Poster Viewing
4:30 Sample Preparation for Point-of-Care Multiplexed Bloodstream Infection Diagnostics
Ian White, Ph.D., Assistant Professor, Fischell Department of Bioengineering, University of Maryland
In this presentation we will review the challenges of a sample-to-answer PCR-based microfluidic bloodstream infection diagnostics system. We will then present novel approaches to enable automated sample preparation in a pragmatic integrated microsystem.
5:00 Digital Microfluidics for Clinical Applications
Aaron Wheeler, Ph.D., Director, Wheeler Microfluidics Lab, University of Toronto
Digital microfluidics (DMF) is an emerging alternative to traditional channel-based microfluidics. In DMF, discrete droplets of samples and reagents are controlled electrodynamically on the surface of an array of electrodes. In this talk, I will review several clinical applications that my lab has implemented that take advantage of the unique properties of DMF.
5:30 Wine and Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing
6:30 Close of Day
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