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AMP asks FDA to address barriers to device innovation
Date:6/25/2010

Washington, DC (June 25, 2010): Yesterday, the Association for Molecular Pathology (AMP) gave public comments at the FDA's Center for Devices and Radiological Health (CDRH) Council meeting on Medical Device Innovation: Barriers to Market for Molecular Diagnostic Tests.

AMP commends the Federal departments and agencies that compose the Council on Medical Device Innovation for making efforts to identify and remove barriers to innovation and progress in transitioning basic and transitional research findings into routine clinical practice. In its remarks, AMP identified three barriers that impede the path to FDA clearance or approval for diagnostic tests and reduce the motivation to submit some medically useful tests for review.

Barrier 1. The paucity of standard reference materials for all areas of molecular diagnostics, i.e., genetic, oncology, and infectious disease testing, inhibits the production of appropriate control materials and methods. "AMP is eager to see more progress and investments in this area," said Dr. Mark Sobel, AMP's Executive Officer. "FDA can assist by providing a list of needed standard reference materials to relevant organizations such as the National Institute of Standards and Technology (NIST) and World Health Organization (WHO)."

Barrier 2. The difficulty of obtaining rare specimens for studies presents a barrier to submission of applications for the approval of new indications for currently approved tests. Herpes Simplex Virus (HSV) testing has been the standard of care for the diagnosis of central nervous system (CNS) disease (HSV encephalitis and meningitis) for over a decade, yet an FDA approved test does not yet exist. HSV CNS infections are relatively rare and any individual laboratory may receive only 1-2 HSV encephalitis positive specimens a year. Manufacturers who developed assays for the novel 2009 influenza H1N1 strain encountered similar difficulties in validating their assays using prospect
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Contact: Mary Steele Williams
mwilliams@amp.org
301-634-7921
Association for Molecular Pathology
Source:Eurekalert

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