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The H1N1 epidemic has illuminated the need for new rapid molecular tests. Opportunities for point-of-care have arisen around the need for faster turnaround time and more sophisticated assays that differentiate strain types of emerging agents and that generate reliable results. This promises to improve healthcare delivery and make patient management more efficient with accurate diagnosis. This conference will provide a forum to discuss how the tests will be reimbursed. Newer applications for point-of-care testing will also be explored that branch out from traditional markets and have the potential to greatly impact treatment. New developments in affordable and innovative options that represent cost savings in healthcare delivery will be given priority status.

Scientific Advisory Board

Shuqi Chen, Ph.D., CEO, IQuum, Inc.

Harry Glorikian, Managing Partner, Scientia Advisors

Jorge A. León, Ph.D., President, Leomics Consulting

Thomas Li, Ph.D., Senior Director, Technology Management, Chief Technology Office, Roche Diagnostics, Pleasanton

Matthew Lorence, Ph.D., M.B.A., Vice President, Marketing and Sales, Tessarae, LLC

Boris Nikolic, M.D., Senior Program Officer, Bill & Melinda Gates Foundation 

Valerie Ng, Ph.D., M.D., President-Elect, ACMC Medical Staff; Chairman, Pathology; Director, Clinical Laboratory, Alameda County Medical Center/Highland General Hospital

Hakan Sakul, Ph.D., Senior Director and Global Head, Diagnostics and Oncology Leads, Molecular Medicine Group, Pfizer Global R&D

7:30 am-6:00 pm Registration 

7:30 Morning Coffee 

 Matthew Lorence, Ph.D., M.B.A., Vice President, Marketing and Sales, Tessarae, LLC 

8:40 Retrospective Study, 1918 Pandemic Virus and 2009 H1N1: Lessons for POCT 

 Jeffery K. Taubenberger, M.D., Ph.D., Chief, Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health 

Novel influenza A virus strains that are transmissible in humans can cause global pandemics. There have been four such pandemics in the last one hundred years - 2009, 1968, 1957, and 1918. The address will examine the genetic relationships between these pandemic and seasonal influenza viruses and discuss diagnostic approaches for different influenza virus strains.  

9:10 Point-of-Care Testing Transforming Health Care and Improving Outcomes 

Christopher Price, Ph.D., Visiting Professor in Clinical Biochemistry, Oxford University 

The challenges in health care today include improving the access to, efficiency and effectiveness of care, as well as poor history of innovation. Point-of-care testing has the potential to address these challenges through transforming clinical practice to improve health outcomes. In order to achieve this there has to be a better understanding of clinical need and evidence of effectiveness, as well as a commitment to changing practice.

9:40 Regulation of Novel Molecular Diagnostic Devices for POC Testing 

Francisco Martinez-Murillo, Ph.D., Staff Fellow, Food & Drug Administration 

Advances in molecular biology research and technology drive innovation in the design and development of new in vitro diagnostic devices. In particular, automation, portability, and usability are making these devices more amenable to function within a point-of-care environment. The talk will cover current FDA approaches to assess the safety and efficacy of new molecular diagnostic IVDs when applied to point-of-care settings.

10:10 Coffee Break 

10:55 Chairperson’s Remarks 

Matthew Lorence, Ph.D., M.B.A., Vice President, Marketing and Sales, Tessarae, LLC

11:00 Revolutionizing the Diagnostic of Infectious Diseases with SMART Point-of-Care (POC) CDs that “Read” DNA Instead of Music 

 Michel G. Bergeron, O.Q., M.D., FRCPC, FCAHS, Professor, Director and Founder, Centre de Recherche en Infectiologie (CRI) de l’Université Laval 

In 2010, it still takes at least two days to identify microbes responsible for infections. By merging genomics, bioinformatics, nanotechnologies, microfluidics, biosensor, microarray and compact disc (CD) technologies, we are developing POC-CDs which detect nucleic acid of microbes in less than one hour. These rapid devices should revolutionize clinical practice by insuring real-time diagnostic of infectious diseases at point-of-care.

 11:30 Printable Paper-Based Immunodiagnostics 

 Tomi Erho, Senior Research Scientist, VTT Technical Research Centre of Finland 

We modified the structural properties of paper and applied inkjet printing to biofunctionalize paper in order to fabricate inexpensive, sustainable and disposable bioassays. We demonstrated a paper-based immunoassay in which transport of fluids and particles, amount of capturing antibodies, as well as the strength of paper in aqueous conditions were controlled. This research is conducted towards the development and design of paper-based diagnostics in the fields of health, well-being, and environmental POC diagnostics, where the main focus is versatility, novel test formats with new design opportunities and low-cost mass production.

12:00 pm Thread-Based Microfluidics and Their Possible Use in Semi-Quantitative Diagnostics 

 Wei Shen, Ph.D., Associate Professor, Australian Pulp and Paper Institute, Department of Chemical Engineering, Monash University 

Multi-filament hydrophilic threads are able to transport liquid through capillary wicking. It has been shown that 3D microfluidic liquid transport channels can be fabricated by sewing a hydrophilic thread onto a supporting material such as a polymer film, or by knitting hydrophilic and hydrophobic threads into a simple pattern. Thread-based microfluidic devices can be used to conduct semi-quantitative chemical and biochemical analysis and therefore have potential in POC applications. In this presentation we report our preliminary studies of the fabrication and application of the thread-based and the thread-paper-based microfluidic devices.

12:30 Luncheon Presentation (Sponsorship Available) or Lunch on Your Own 

2:00 Chairperson’s Remarks 

Harry Glorikian, Managing Partner, Scientia Advisors 

2:10 Assessing the Wider Benefits and Economic Impact of a New Diagnostic/Treatment: The UK Experience 

Mirella Marlow, M.B.A., Programme Director – Devices and Diagnostic Systems, Centre for Health Technology Evaluation, National Institute for Health and Clinical Excellence 

NICE provides national guidance and sets standards on good health promotion and the prevention and treatment of ill health for the UK’s NHS. NICE uses comparative effectiveness to achieve consistent clinical standards across the NHS and to ensure uptake of cost-effective healthcare innovations. Dr. Garner will present NICE’s new arrangements for the evaluation of diagnostic technologies and discuss the implications.

2:40 Cradle to Grave Issues with Reimbursement 

 Vickie Baselski, Ph.D., D(ABMM), FAAM, Professor, Department of Pathology and Laboratory Medicine, University of Tennessee Health Science Center 

One of the major factors enabling point-of-care diagnostics is the ability to correctly code and get adequately paid for testing performed. Accomplishing this requires both time and effective interaction between many stakeholders including the IVD industry, the laboratory industry, the physician community, professional societies representing these groups, particularly AMA for correct coding, and most importantly, both CMS and other third party payers who establish fee schedules and criteria for payment. This presentation will describe the many issues that may arise during this complex set of interrelated interactions.

3:10 Refreshment Break 

4:00 Point-of-Care Testing Beyond Glucose Management: Enhancing Clinical Decision Making through Patient Side Testing  

Yolanda A. Cillo, M.D., M.B.A., Medical Director, Abbott Point of Care

Clinical diagnostic and therapeutic decisions are judgments made by health care providers arrived at through the collection and analysis of information including patient history, physical examination and available diagnostic information. Providing lab quality diagnostic information rapidly at the patient’s side provides real time information that can expedite the diagnosis, treatment and ultimately disposition of a patient to the proper hospital setting or to home. Streamlining the process associated with laboratory analysis through patient side testing can enhance compliance with guidelines and may impact safety and diminish the amount of blood required to be drawn for analysis.
 

4:30 Exporting Cervical Cancer Prevention to the Developing World: The Promise and the Challenges 

 Philip Castle, Ph.D., Senior Investigator, Hormonal and Reproductive Epidemiology Branch, Division of Cancer Epidemiology and Genetics, U.S. National Cancer Institute, NIH, DHHS 

Cervical cancer is the second most common female tumor worldwide, with almost 500,000 incident cases and 275,000 related deaths annually. Low-cost molecular screening tools for detection of human papillomavirus, the necessary cause of cervical cancer, may provide a robust method for secondary prevention for this highly preventable disease.

5:00 Opening Reception in the Exhibit Hall

6:00 Close of Day

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