Monday, November 16, 2015

FDA Tells World (And Hill) It Needs to Regulate LDTs

On November 16, 2015, the FDA released a detailed white paper on why LDTs need to be more stringently regulated.

The FDA Blog introduces the topic, authored by Peter Lurie (here).   The FDA's homepage for the report on LDT safety and problems is here.   The FDA's 39 page white paper is here and assesses potential risks and harms associated with twenty different LDT tests.

The report went up the day before FDA will testify at a Hill hearing on the need to regulate LDTs.

The WSJ covered the report in a home page lead article, online here.

The FDA reaches back to some golden oldies like Ovacheck and Ovasure and KIF6.  They discuss the major scandal that developed around a MAAA-like test used at Duke that "blew up" on its investigators and the medical school (e.g. Sixty Minutes, here).

FDA also cites some name-brand concerns, such as the "Oncotype DX Her2 Breast Cancer RT PCR Test."  They call into question some aspects of LDT based NIPT testing.  They also cite uncertainties regarding the Prolaris prognostic MAAA test.

They raise concerns about LDT equivalents, variants, or versions of FDA approved tests like V600E BRAF tests (e.g. Roche Cobas test).  Regarding the BRAF LDTs offered by labs, the "FDA is not aware of evidence to support claims of superior performance."  The FDA cites one company's broad gene panel test for management of advanced cancer against the FDA concern: "Patients undergoing this test may forego standard treatment and opt for the list of alternatives put forth on the test report, even though the test has not been clinically validated."

Throughout the document, there are locations here and there where the FDA makes some pretty wild swings in terms of extrapolations or concerns.