The Tests Are Vital. But Congress Decided That Regulation Is Not. — ProPublica

"Do I need a pile of dead bodies before somebody says enough is enough?"… 

While the Centers for Medicaid and Medicare monitor the quality standards in labs, no federal agency checks to make sure lab-developed tests work the way they claim to before they reach patients; similarly, no agency vets the marketing before the tests are sold. Companies aren't required to publicly report so-called adverse events — incidents that happen when the tests get it wrong. And no federal agency has recall authority….

https://www.propublica.org/article/prenatal-screening-cancer-tests-regulation