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AMP urges inclusion of molecular diagnostic tests in comparative effectiveness research
Date:6/16/2009

Washington, DC June 12, 2009 -- The Association for Molecular Pathology (AMP) today released the text of a comment letter it has provided to the Federal Coordinating Council for Comparative Effectiveness Research (CER) in which AMP sets forth its recommendations for priority areas on which to focus CER activities.

"CER is garnering substantial attention in Congress and among other policy makers who see it as a method to examine the comparative effectiveness of treatments, including how they relate to coverage and reimbursement decisions" wrote AMP President Jan A. Nowak, MD, Ph.D. "Diagnostic tests will most definitely be included in this paradigm, especially when the effectiveness of treatments will vary among different population subgroups. Unfortunately, the value of diagnostics in improving clinical outcomes has not been appreciated adequately in the past; therefore, considering the role of genomics under CER will be critical."

Dr. Nowak continued to say that in order for CER to be a success, it will be essential to train experts in diagnostics (including molecular diagnostics) in current health services research methods as well as to train health services researchers in the technical areas they will assess. This cross training will be essential to ensure that the research methods are technology appropriate.

"There is much less experience in assessing the role of the diagnostic test itself in appropriate and cost effective management of individual patients," wrote Dr. Nowak. "Therefore, AMP encourages the Coordinating Council to invest in the cross-training of researchers and diagnostics experts as well as to build the infrastructure within the agencies to understand and review data from different types of technologies."

The AMP letter recommends the devepment of a model process for CER regarding clinical laboratory tests. This model should include the creation of a panel of experts consisting of physicians and scient
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Contact: Mary Steele Williams
mwilliams@amp.org
301-634-7921
Association for Molecular Pathology
Source:Eurekalert

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