08:00 | Conference Registration and Continental Breakfast in the Exhibit Hall. Exhibit Hall Opens. |
| Session Title: Emerging Themes and Technologies in Point-of-Care (POC) Diagnostics |
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09:00 | | Keynote Presentation Point of Care, Companion Diagnostics, and the Personal Diagnostic Environment Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation, United States of America
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09:30 | | Keynote Presentation Mobile Health Care: Patient-Centered and Frictionless Gene Dantsker, Director, Business Development and Licensing, Qualcomm LIFE, Inc., United States of America
Modern health care is undergoing an unprecedented shift from volume-driven to value-driven medicine, characterized by outcome-based payment models and enabled by disruptive technologies that are decentralizing health care and engaging the patient. As new technologies continually promise to deliver quality diagnostics to patients much closer to the point-of-care, the point-of-care itself is shifting and the home is now the fastest growing health care setting in the US. The power and reach of wireless technology is making this care setting safe, secure, and ideal for healing. We will talk about factors that are driving the shift toward mobile, patient-centered health and how connected health solutions using mobile technology are transforming health care. |
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10:00 | | Keynote Presentation Evolving Reimbursement Landscape’s Impact on Point-of-Care Testing Yolanda Cillo, Medical Director, Abbott Diagnostics, United States of America
Some insurers and reimbursement agencies regard point of care testing as a simple technology that should therefore receive less reimbursement. But not all point of care testing uses the same technology and point of care testing that does not utilize a ‘strip’ to measure values produces results comparable to the central laboratory employing complicated and advanced scientific principles and technologies. Recent changes in reimbursement for point of care testing places increasing pressure on companies to demonstrate the value of such point of care testing to justify sufficient reimbursement for these technologically advanced point of care tests. This talk will review the changes in current reimbursement status, explore how the economics of point of care testing impacts more than just the laboratory budget and discuss how outcomes and quality measures are related to the value of point of care testing. |
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10:30 | Coffee Break, Networking, Visit the Exhibitors and Poster Viewing |
11:00 | | Keynote Presentation Non-Communicable Diseases in Global Health Settings – New Opportunities, True Value and Proper Valuation of Point-of-Care Diagnostics Bernhard Weigl, Director, Center for In-Vitro Diagnostics, Intellectual Ventures/Global Good-Bill Gates Venture Fund, United States of America
The emergence of point-of-care (POC) diagnostics specifically designed for low-resource settings (LRS) coupled with the rapid increase in need for routine care of patients with chronic diseases should prompt reconsideration of how health care can be delivered most beneficially and cost-effectively in developing countries as well as in non-traditional and home care settings in developed countries. Bolstering support for primary care in LRS to provide rapid and appropriate integrated acute and chronic care screening, diagnosis, and treatment may be a possible solution. POC diagnostics can empower local and primary care providers and enable them to make better clinical decisions. This talk explores the opportunity for POC diagnostics to strengthen primary care and chronic disease diagnosis and management in a low resource setting (LRS) to deliver appropriate, consistent, and integrated care, as well as present examples of diagnostic technologies for diabetes and other chronic conditions that are targeted to those settings. We analyze the requirements of resource appropriate chronic disease care, the characteristics of POC diagnostics in LRS versus the developed world, the many roles of diagnostics in the care continuum in LRS, and the process and economics of developing LRS-compatible POC diagnostics. |
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11:30 | Point of Care Technologies in the Diagnosis of Breast Cancer in Both Resource-Rich and Poor Settings Jane Brock, Chief of Breast Pathology, Brigham and Women’s Hospital, Harvard Medical School, United States of America
Breast Cancer care includes prevention, early detection, diagnostics and therapeutics. Therapeutic decisions are made based on traditional prognostic factors including tumor size, lymph node status, and factors obtained from pathological assessment including tumor grade, immunohistochemical profile of Estrogen and Progesterone Receptor (ER and PR) and Her2/neu gene amplification status. Point of care technology is not currently used in this routine pathological assessment, but there are opportunities to both expedite diagnosis and reduce costs in both resource-rich and poor settings. This presentation will discuss alternative methods of tissue biopsy handling and imaging, that can obviate the need for expensive processing equipment (that is rarely available in resource-poor settings), and can allow for rapid diagnosis, compared with traditional tissue processing (within fifteen minutes rather than > 24 hours). Tissue diagnosis by a pathologist remote from the point of care technology is also possible (pathologists are rarely available in resource-poor settings). The utility of providing a more rapid diagnosis in resource-rich settings will be increasingly apparent, as pre-treatment tumor samples are now routinely obtained to assess molecular signatures of targeted therapeutic susceptibility or resistance in the research setting. Rapid prognostic marker diagnosis, using either fresh or fixed tumor mRNA PCR, could easily replace the traditional histological evaluation for tumor grade, and ER, PR and HER2 status evaluation by immunohistochemistry on formalin-fixed, processed tissue specimens. Such simple PCR amplification technology can provide the prognostic marker results within just a couple of hours, and can be a cheaper viable alternative for providing prognostic marker information, as it requires less skilled labor, both for the testing procedure and reading the test results, along with fewer reagents and fewer pieces of equipment overall. As such, it is |
12:00 | Networking Lunch in the Exhibit Hall, Visit the Exhibitors, and Poster Viewing |
13:00 | Technology Spotlight: Isothermal Amplification Detection Roberto Spricigo, OEM Manager, Point-of-Need, QIAGEN Lake Constance
The need for a thermal cycling instrument or a skilled technician to perform a PCR assay can sometimes be prohibitive for resource-poor settings. The presentation gives an overview on isothermal amplification technologies and the new dedicated solutions provided by QIAGEN Lake Constance GmbH. Sensing nucleic acid sequences is crucial for modern biology and medicine. This sector has grown exponentially since the 1990s and it is likely to continue to increase in its importance over the next few decades. |
| Session Title: Point-of-Care (POC) Diagnostics in Resource-Limited Settings and for Global Health |
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13:30 | | Keynote Presentation Your CD Player as a Medical Diagnostics Device Marc Madou, Chancellor's Professor, University of California-Irvine, United States of America
Nucleic-acid (NA) based diagnostics hold much potential, especially for the more rapid and accurate diagnosis of infectious diseases. However, nucleic acid diagnostics are still impractical to implement in many settings, requiring, to name a few, large and expensive labs with sophisticated equipment, a well-trained staff, and many hours of labor. As a part of the shift towards de-centralized and low-cost healthcare, microfluidic platforms aim to move nucleic-acid based diagnostics out of the laboratory and to the point-of-care (POC). This talk focuses on the research, design, and development of centrifugal microfluidic platforms as tools for nucleic acid analysis and diagnostics. In particular, novel microfluidic systems are presented towards sample-to-answer in vitro diagnostic applications, to make nucleic acid diagnostics a reality by overcoming many of the current hurdles. |
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14:00 | Non-Invasive Methods of Diagnostics for Women’s Health Barbara Smith, Assistant Professor, School of Biological and Health Systems Engineering, Arizona State University, United States of America
Development of translational diagnostics tools, including: (i) molecular diagnostics on paper, and (ii) olfactory sensing for early cancer detection. The goal of this work is to develop useful point-of-care devices that are translated from the bench-top into the hands of the user.
- Molecular diagnostics on paper. We are developing a completely on-board assay - from sample to results. In this work, paper is used as a microfluidic platform, where reagents are stored and the device provides a basis for multiplexed detection of nucleic acids. The detection is made to be low-cost, simple-to-use and easy-to-read, non-invasive, fieldable, and fully disposable.
- Olfactory sensing. We are detecting volatile organic compounds (VOC’s), specific to cancer cells. Through the determination of these biomarkers, we aim to develop an external sensor for the point-of-care, non-invasive detection of cancer.
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14:30 | Design for Point-of-Need Testing in the Developing World Marya Lieberman, Professor, University of Notre Dame, United States of America
This talk will focus on design of paper millifluidic devices for chemical analysis outside a laboratory setting. The main analytical applications that our group has pursued are detection of low quality or fake pharmaceuticals and quantitative analysis of the iodine content of iodized salt. Paper test cards for analysis of five antibiotics (ampicillin, amoxicillin, amoxicillin/clavulanate, azithromycin, and ciprofloxacin) are being implemented in the pharmacovigilance system of the second largest hospital in Kenya, and a titration-on-paper card is undergoing external validation studies and technology comparison studies at labs in South Africa and Burkina Faso. Because academic researchers in the developed world are sometimes frustrated when they attempt to translate laboratory prototypes to field studies in the developing world, this talk will focus on design features that made the test cards more acceptable for users in the developing world. Key design elements included bringing researchers to the field setting to better understand user constraints , maintaining connections to users; selection of analytical targets that our users think are most important; using cell phones to read card results, which makes the devices easier to use; and a life-cycle approach that maximizes ease of manufacture and minimizes the hazard and environmental impact of the cards. The resulting point-of-need devices balance sensitivity, selectivity, and robustness in order to meet the user's analytical goals in a field setting where instruments, electricity, reagents, and laboratory equipment are often not available. |
15:00 | Coffee Break, Networking, and Visit the Exhibitors |
15:30 | Creating Point-of-Care Diagnostics for Use in Resource-Limited Settings: Lessons Learned from South Africa Paul Drain, Instructor of Medicine, Harvard Medical School, United States of America
Point-of-care diagnostics have improved dramatically in accuracy, rapidity, accessibility, and cost during the last several decades. While rapid diagnostic tests for HIV have been widely adopted worldwide, newer molecular tests for tuberculosis are facing operational challenges and programmatic resistance. The Xpert MTB/RIF assay–a rapid molecular diagnostic test for tuberculosis–was endorsed by the World Health Organization in 2010. By June 2014, 3,269 GeneXpert instruments and over 7.5 million Xpert MTB/RIF tests had been procured in developing countries. South Africa has a very high burden of tuberculosis, and started implementing the Xpert MTB/RIF assay throughout national laboratories in 2011. Although the test has been called a “game changer,” nearly every study in South Africa has shown that Xpert MTB/RIF has not had a significant clinical impact or been cost-effective. I will present our study data demonstrating that centralized use of Xpert MTB/RIF was slower than conventional tuberculosis tests (e.g. culture and smear microscopy), and summarize additional studies on the application and clinical impact of the test’s rollout in South Africa. By reviewing the experience of South Africa’s real-world experiment in introducing a rapid molecular diagnostic test, I will highlight the critical lessons learned for the future design and implementation of advanced diagnostics for infectious diseases. I will present our revised criteria for an ideal diagnostic point-of-care test, which were recently published in The Lancet. Finally, I will summarize the appropriate clinical evaluations of these tests and conclude with common benchmark criteria that novel point-of-care diagnostics should achieve in order to gain widespread global use. |
16:00 | One Size Fits All – A Microfluidics-enabled Platform for a Broad Range of POC Diagnostic Assays Holger Becker, Chief Scientific Officer, Microfluidic ChipShop GmbH, Germany
Microfluidics has emerged as one of the crucial enabling technologies for POC diagnostics. The ability to integrated complex diagnostic assays, especially molecular diagnostic assays onto a single consumable has led to a dramatic growth of academic and commercial activities in this field. The big challenge however remains that such solutions in the past have typically been disease-specific, leading to the necessity to have a variety of different systems in a diagnostic lab. We present here a universal microfluidic-enabled POC platform which is capable of performing molecular diagnostic, immunodiagnostic and clinical assays with a single system. As demonstrator cases, a molecular assay for TB, an immunoassay for HIV and a clinical assay for ALT will be presented which all run on this single benchtop instrument platform. |
16:30 | Non-Invasive Biomarker Sensing Through Sweat Jason Heikenfeld, Professor and VP Operations, UC Office of Innovation, University of Cincinnati, United States of America
Using sweat for non-invasive access to biomarkers has shown promising clinical results for decades. A compelling commercial scenario is now upon us, enabled by advances in wearable electronics, low-cost electronic mM to pM sensing techniques, and a deeper understanding of how biomarkers partition into sweat. We present the latest results from a large consortium of researchers lead by the University of Cincinnati, in creation of sweat patches for continuous physiological monitoring. |
17:00 | Microfluidic Blood Cell Counters for Biomedical Diagnostics Rashid Bashir, Professor And Head, University Of Illinois, United States of America
Integration of biology, medicine, and fabrication methods at the micro and nano scale offers tremendous opportunities for solving important problems in biology and medicine and to enable a wide range of applications in diagnostics, therapeutics, and tissue engineering. Microfluidics and Lab-on-Chip can be very beneficial to realize practical applications in detection of disease markers, counting of specific cells from whole blood, and for identification of pathogens, at point-of-care. The use of small sample size and electrical methods for sensitive analysis of target entities can result in easy to use, one-time-use assays that can be used at point-of-care. In this talk, we will present our work on detection of T cells for diagnostics of HIV AIDs for global health, development of a CBC (Complete Blood Cell) analysis on a chip, electrical detection of multiplexed nucleic acid amplification reactions, and detection of epigenetic markers on DNA at the single molecule level. While the above mentioned devices are built with PDMS or silicon, bio-printing with stereolithography can be a very powerful technology to produce bio-hybrid devices made of polymers and cells such as biological machines and soft robotics. These devices could have potential applications in drug delivery, power generation, and other biomimetic systems. |
17:30 | Portable Platform Technologies for Detecting Pathogens and Cells at the Point-of-Care Utkan Demirci, Professor, Stanford University School of Medicine, United States of America Fatih Inci, Postdoctoral Research Fellow, Stanford University School Of Medicine, United States of America
Micro/nano-scale technologies can have a significant impact on medicine and biology in the areas of cell manipulation, diagnostics and monitoring. At the convergence of these new technologies and biology, we research for enabling solutions to the real world problems at the clinic. Emerging nano-scale and microfluidic technologies integrated with biology offer innovative possibilities for creating intelligent, mobile medical lab-chip devices that could transform diagnostics and monitoring, tissue engineering and regenerative medicine. In this talk, we will present an overview of our laboratory's work in these areas focused on applications in point-of-care and primary care settings including applications for ovarian cancer detection from urine, rapid CD4 counts for global health, multiple pathogen detection with a focus on viral load from unprocessed whole blood and bedside peritonitis detection for end-stage kidney disease patients going through peritoneal dialysis therapy. These emerging technologies could shape our future creating broadly applicable platforms for scientific discovery, providing clinical solutions for resource-constrained settings in the developing world as well as for primary care settings in the developed world. |
18:00 | Networking Reception: Enjoy an Awesome Evening and Network with your Fellow Delegates, Visit Exhibitors, and View Posters. Beer, Wine, and Appetizers will be Served |
20:00 | Close of Day 2 of the Main Conference |