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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