Shuren: LDT Reliability Critical To Precision Medicine Initiative
This article was originally published in The Gray Sheet
The head of CDRH said the agency's efforts to oversee laboratory developed tests are critical to ensuring reliability of genetic tests in conjunction with the president's Precision Medicine Initiative.
You may also be interested in...
ACLA has recruited Laurence Tribe and Paul Clement, two prominent constitutional legal guns with Supreme Court expertise, to fight FDA over its proposed lab-developed test guidance. The announcement is perhaps the lab industry's most high profile move yet to oppose FDA's plan to regulate lab-developed test services under the device statute with a risk-based phase-in plan.
Two promised draft guidances on FDA’s framework for regulating laboratory developed tests and notification and medical device reporting requirements for LDTs have been posted. The agency wants swift notification from labs for most available LDTs once a framework is finalized.
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.