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CAP Leaders Stress Need for Oversight of Direct-to-Consumer and Laboratory Developed Tests

Tue, 07/20/2010 - 5:33am
Bio-Medicine.Org

College of American Pathologists Outlines Recommendations at Food and Drug Administration Meeting

WASHINGTON, July 20 /PRNewswire-USNewswire/ -- With the increasing importance of laboratory tests in diagnosing and treating disease, representatives of the College of American Pathologists (CAP) today presented recommendations to the Food and Drug Administration (FDA) urging increased oversight of laboratory developed tests (LDTs) and "direct-to-consumer" tests. Most genetic tests fall into one or both of these testing categories.

"As physicians responsible for ensuring laboratory quality and rendering diagnoses based on laboratory tests, the CAP believes there is a need for FDA to increase its oversight of certain laboratory developed tests, including high-risk and direct-to-consumer tests," said Gail Habegger Vance, MD, professor of Medical and Molecular Genetics at the Indiana University School of Medicine (IUSM) in Indianapolis and a member of the CAP Board of Governors.  

Since the implementation of the 1976 Medical Device Amendments, the FDA has generally not used its oversight authority to enforce applicable regulations with respect to LDTs.  The FDA convened today's meeting to hear testimony about key issues that it will consider as it develops new regulations that would apply risk-based oversight of LDTs.

Late last year, the College introduced its own model for increased oversight of LDTs, and shared it with the FDA at that time. The

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