The longstanding debate about FDA regulation about lab developed tests rears its head again in February 2022. After a New York Times report that was negative about NIPT (and, I think, pretty misleading), 100 legislators wrote the FDA this month asking for FDA to take action on LDTs. FDA has responded already, that it would be happy to, given better legislation.
See the full story and numerous hyperlinks in an open-access article released on February 24, 2022, by Michael Mezher at REGULATORY FOCUS.
See also a story on this week's Friends of Cancer Research meeting, where FOCR released a white paper on faster approval of rare biomarkers. At the same FOCR meeting, drop-in speakers Repr. Bucshon and DeGette championed their regulatory bill, which is called VALID.
