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2013 Archived Content

Enabling Point of Care Diagnostics 

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Recommended Conference Short Courses*

Applications of Detection Theory in Diagnostics

The Future of Point-of-Care Diagnostics 

*Separate registration required

Scientific Advisory Board

Harry Glorikian, Founder & Managing Partner, Scientia Advisors LLC
Matthew Lorence, Ph.D., M.B.A., SVP, Marketing, Sales, and Business Development, TessArae, LLC
Katherine Tynan, Ph.D., Business Development & Strategic Consulting for Diagnostics Companies, Tynan Consulting LLC
Penny Wilson, Ph.D., Lead Specialist, Detection and Identification of Infectious Agents, Technology Strategy Board


7:30 am Registration and Morning Coffee


8:30 Chairperson’s Opening Remarks

Gerald J. Kost, M.D., Ph.D., MS, Professor, Pathology and Laboratory Medicine; Director, Clinical Chemistry and Point-of-Care Testing; Faculty, Biomedical Engineering and Comparative Pathology, University of California, Davis

8:40 Emergency and Disaster Point-of-Care Testing: Cardiac Biomarkers, Complex Chaos, and Sustainable Resiliency

Gerald J. Kost, M.D., Ph.D., MS, Professor, Pathology and Laboratory Medicine; Director, Clinical Chemistry and Point-of-Care Testing; Faculty, Biomedical Engineering and Comparative Pathology, University of California, Davis

Point-of-care (POC) testing enables on-site decision-making where it counts most at points of need in ERs, complex emergencies/disasters, and small-world networks. New national policies and guidelines are harmonizing heretofore chaotic change, morphing “POC culture” where patients take ownership of medical care and improve sustainability in low-resource settings. Now, the U.S. also can adopt guidelines and national policy that enhance resiliency!

9:10 A New Open-Source Point-of-Care Test (POCT) System for Emergency Room and Physician’s Office Labs

Chong H. Ahn, Ph.D., Mitchell P. Kartalia Chair and Professor, Microsystems and BioMEMS Laboratory, School of Electronics and Computing Systems, University of Cincinnati

A new open-source POCT system for use in Emergency room labs and Physician’s office labs will be presented in this talk. The open-source and rapidly reconfigurable nature of the POCT system provides rapid assay conversion to POCT, “tunable” ultra-high sensitivity, and wide-dynamic range for cardiac Troponin-I as well as b-hCG. Thus, this POCT system allows the user of POCT have the quality of lab-based methods.

9:40 Biomarkers and POCT in Patients with Heart Failure

Adam J. SingerAdam J. Singer, M.D., Professor and Vice Chairman for Research, Department of Emergency Medicine, Stony Brook University

Heart failure is one of the most costly and common reasons for hospital admission and readmissions within 30 days in the USA. This lecture will briefly review the pathophysiology of heart failure and the role of biomarkers in the diagnosis and management of heart failure. It will then discuss the specific role of point-of-care testing in ED patients with suspected heart failure and its role in improving care.

10:10 Coffee Break


10:55 Chairperson’s Remarks

Matthew Lorence, Ph.D., MBA., Senior Vice President, Marketing, Sales, and Business Development, TessArae, LLC

11:00 The Changing Landscape in Point-of-Care Diagnostics: Advances in Developing World Applications and Their Potential Impact in Developed Markets

Rich ThayerRich Thayer, Managing Partner, Halteres Associates, LLC; CEO, Catalysis Foundation for Health

Understanding unmet needs and business model options prior to initiating development of POC systems for limited resource settings is essential for success. Learn how advancements in diagnostics technologies and communications, in addition to a better understanding of local market conditions and needs, are driving increased interest in delivering diagnostic solutions for these important markets.

11:30 Improving Patient Access to HIV/AIDS Diagnostics in Developing Countries

Randy AllenRandy Allen, Ph.D., Manager, Corporate Relations, Clinton Health Access Initiative (CHAI)

Diagnostics products used in the developed world do not adequately serve resource-limited settings (RLS) with insufficient electricity, transportation, and trained healthcare workers. Scale-up of patient access to diagnostics will require more productive use of conventional technologies and implementation of Point-of-Care (POC) products specifically designed for RLS. Opportunities now exist for widespread scale-up of cost-effective diagnostics in developing countries.

12:00 pm Enabling POC Diagnostics through Standard Setting

Gene Walther, MBA, Deputy Director, Diagnostics, Discovery, Bill & Melinda Gates Foundation

Accurate and timely medical diagnosis is a critical step in the successful treatment of disease. In the developing world, where illness due to malaria, TB, HIV and other infectious diseases is a daily reality for millions, appropriately designed diagnostic tests are often not available or affordable. Through the establishment of product, regulatory and business standards, the development of needed diagnostics can be developed and deployed more effectively. This session will discuss the efforts to establish these standards to improve POC diagnostics for the global health market.

QIAGEN12:30 Current Requirements in POC´s World: A Short Overview

Roberto Spricigo, Ph.D., Manager, Strategic Alliances & OEM, QIAGEN Lake Constance

Rapid point-of-care (POC) tests are emerging as tools for more efficient diagnosis and patient evaluation. They are becoming more meaningful to healthcare professionals by giving quantitative results. Here we explain the current requirements for POC devices for rapid test and isothermal amplification applications.

12:45 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

2:00 Session Break


2:15 Chairperson’s Remarks

John T. McDevitt, Brown Wiess Professor, Bioengineering & Chemistry, Rice University

2:20 Programmable Bio-Nano-Chip Systems for Serum CA125 Quantification: Toward Ovarian Cancer Diagnostics at the Point-of-Care

John T. McDevitt, Brown Wiess Professor, Bioengineering & Chemistry, Rice University

We report the adaptation of the programmable bio-nano-chip (p-BNC), an integrated, microfluidic, and modular (programmable) platform for CA125 serum quantitation, a biomarker prominently implicated in multimodal and multimarker screening approaches.

Axxin logo2:50 Bringing Molecular Amplification to Point of Care Settings

Andrew Lysikatos, MBA, CEO, Axxin

Isothermal amplification methods are coming of age and offer advantageous characteristics over the polymerase chain reaction method, bringing rapid molecular detection of infectious diseases to the clinical lab and to the point- of-collection settings. New equipment is being developed, simpler and less expensive than thermocyclers, allowing rapid deployment of the technology into R&D labs, clinical labs, POC settings and field applications.

3:20 Refreshment Break in the Exhibit Hall with Poster Viewing



4:10 Panel Discussion: What Stakeholders Want from POC

Moderators: Keith F. Batchelder, M.D., CEO, Genomic Healthcare Strategies

Peter S. Miller, COO, Genomic Healthcare Strategies

  • Patient empowerment
  • Help providers and payers measure outcomes
  • Prescription compliance
  • Drive to lower cost in healthcare system
  • Use in clinical trials and near patient testing in hospitals

Panelists: Sally Okun, RN, MMHS, Vice President, Advocacy, Policy & Patient Safety, PatientsLikeMe

Rob Havasy, Project Specialist and Operations Manager, Center for Connected Health, Partners HealthCare System, Inc.

James Kelly, M.S., Ph.D., Vice President, Regulatory Affairs, Alere, Inc.

Michael Nohaile, Ph.D., Vice President, Corporate Strategy, Amgen, Inc.

Mark Alexandre Rogers, M.D., Head, Near Patient Testing Unit, Novartis

5:10 Wine and Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing

6:10 Close of Day

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