Posts Currently viewing the tag: "LDT Regulation"

Following quickly on the heels of the AACR statement in support of FDA regulation of LDTs, the co-founder of The Coalition for 21st Century Medicine, Kathleen Wilsey, today presented to Congress testimony that includes significant concerns about the potential for negative impacts from FDA regulation. The Coalition’s general concerns are that FDA’s…(Read More)

In response to congressional pressure, FDA has released a copy of its long-awaited draft guidance covering regulation of LDTs. FDA seems to have addressed many if not all of the concerns regarding negative impacts from LDT regulation, at least in writing the guidance. Actual implementation will be interesting to watch, but several things about…(Read More)

Five U.S. Senators have signed a letter urging the Office of Management and Budget (OMB) to released a draft guidance on LDT regulation. OMB apparently has 90 days to review regulatory policies but has held the FDA’s draft guidance on LDTs “for several years.” While FDA has hinted in the past that it…(Read More)

FDA’s warnings to 23andMe illustrate some of the major problems with current regulation of diagnostic tests. 23andMe uses a CLIA-certified lab to perform its test and so is within its rights, like all CLIA labs, to offer a test developed and run in its own lab (a lab-developed test, or LDT). FDA…(Read More)

Margaret Hamburg took the opportunity, at the end of a speech honoring a colleague at the annual meeting of the American Society of Clinical Oncology (ASCO), to make some pointed comments that should make LDT developers every more concerned about impending regulation of their wares. Key quote: Hamburg then states that the FDA “is working…(Read More)