Wednesday, February 1, 2017

Brief Blog: ACS and Others Ask Hill for LDT Oversight

In November, post-election, the FDA announced it was tabling the release of final guidance documents on LDT regulation (here, here).   Two months later, in mid January, the FDA released a white paper on its latest thinking as a result of two years of back-and-forth on LDT regulation (here, here, here, here).

On January 24, 20-17, 30-plus organizations, including the American Cancer Society, urged that "updating the LDT framework" be a priority of this Congress.   The two-page PDF is online here.

These stakeholders write,
There is no systemic way to be sure of the accuracy and reliability of these tests. Several cases illustrate the challenges with this lack of oversight. Researchers sent samples from the same cancer patients to different LDT providers for cancer testing, and found only 25 percent of the drug recommendations based on test results overlapped.
...The current system of LDT oversight is inadequate and needs updating.
The letter is addressed directly to the Senate Majority Leader and the Senate Minority Leader, rather than to committees in the House or in the Senate.  Coverage at Genomeweb, here.

On February 1, 2017, the trade journal CQ Healthbeat ran an article that LDT regulation is again on the Hill agendas for this year, given the support both of the clinical groups cited above and the joint support for some level of regulation revision at both Advamed and ACLA.