They Trusted Their Prenatal Test. They Didn’t Know the Industry Is an Unregulated “Wild West.”

December 6, 2022

(ProPublica) – If she had taken any number of other common commercial tests — including certain tests for COVID-19 or, say, pregnancy — the company would have been required to inform the U.S. Food and Drug Administration about reports of so-called adverse events. But the test Amanda had falls into a regulatory void. No federal agency checks to make sure these prenatal screenings work the way they claim before they’re sold to health care providers. The FDA doesn’t ensure that marketing claims are backed up by evidence before screenings reach patients. And companies aren’t required to publicly report instances of when the tests get it wrong — sometimes catastrophically. (Read More)