September 2022—Like so many pathologists, I have been keeping a close eye on the VALID Act, which would create a new framework for FDA oversight of laboratory-developed tests (LDTs). As I write this, the VALID Act has been voted out of a Senate committee and now awaits further action by the full Senate. I have heard from some pathologists and laboratorians who are concerned about this legislation and about the CAP position on it since the Senate HELP Committee released a draft on May 17, 2022. If you have not followed this bill and the issues of LDT oversight, allow me to offer some context. Regulatory oversight of LDTs has been in active discussion since 2008 when the FDA intervened with a national reference laboratory that was selling a test that had been developed at a prestigious university to identify high-risk women who might have ovarian cancer. Patient advocacy groups had raised a concern because several women had undergone unnecessary prophylactic bilateral oophorectomy based on this LDT. In response, the FDA expressed concern about the public harm, and the reference laboratory pulled the test from the market.
