12:00 AM
Sep 20, 2016
 |  BC Extra  |  Politics & Policy

HELP committee hears testimony on LDT oversight

Members of the U.S. Senate Health, Education, Labor and Pensions Committee and the four witnesses who testified in front of the committee on Tuesday agreed that there is a need for more oversight of laboratory-developed tests, but disagreed which agency should regulate the tests.

In 2014 draft guidance, FDA proposed an oversight framework that would phase in regulation over a nine-year period and enforce premarket review requirements based on risks associated with LDTs. According to the draft, CMS, which currently oversees LDT regulation under the Clinical Laboratory Improvement Amendments (CLIA), would continue to oversee laboratory operations (see BioCentury, Aug. 11, 2014).

"We believe additional regulatory oversight of our labs, such as that proposed by FDA,...

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