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

In a press release, the College of American Pathologists have Stressed Need for Oversight of Direct-to-Consumer and Laboratory Developed Tests:

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.

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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.

Interesting, and this comes in the same timeframe in which the FDA are looking into regulating genetic testing as well.