IRVINE, California, and AMSTERDAM, July
15, 2010 /PRNewswire/ — Agendia, a world leader in
molecular cancer diagnostics, announced today that company CEO Dr.
Bernhard Sixt will provide testimony
at a public meeting on July 20 in
Washington D.C. on the federal
regulation of laboratory developed tests (LDTs). Jointly organized
by the Food and Drug Administration (FDA) and Center for Devices
and Radiological Health (CDRH), the Public Meeting on Oversight of
Laboratory Developed Tests will be a forum for key stakeholders,
including laboratory professionals, clinicians, patients and
industry leaders, to discuss and define the issues surrounding LDT
regulation which pose the greatest risk to the public health. Dr.
Sixt will present in Session II, “Oversight of LDTs: Clinical
Laboratory Challenges.”
Since the implementation of the 1976 Medical Device Amendments,
the FDA has exercised enforcement discretion over LDTs, but has not
pursued active regulation of the category. However, in recent years
these tests have become increasingly complex and high risk in
nature, and are playing an important role in clinical
decision-making. As a result, the FDA has decided that LDTs which
have not been properly validated put patients at risk, and that a
risk-based application of oversight for the category is
appropriate.
Agendia joins the FDA among other leading organizations,
including Genentech, the College of American Pathologists, and the
Genetics & Public Policy Center at Johns
Hopkins University, in calling for a tiered risk-based
approach to the regulation of LDTs. As the nation’s leading
authority for patient safety, Agendia believes that only the FDA
can regulate the
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