FDA Finally Moves to Scrutinize Specialized Health Screenings

May 1, 2024

An array of vials from blood tests.

(ProPublica) – The agency issued a rule that brings new scrutiny to a range of critical lab-developed tests, including certain cancer and prenatal screenings. ProPublica previously reported how lab-test accuracy and marketing had skirted federal oversight.

The Food and Drug Administration issued a rule on Monday that brings new scrutiny to a vast array of critical lab tests, including some popular prenatal genetic screenings, that reach patients without any federal agency checking to ensure they work the way their makers claim. (Read More)