Time is running out for Congress to act on medical device regulation

Early this year, the New York Times ran a story about a woman who almost terminated her pregnancy because a genetic non-invasive prenatal screening (NIPS) test showed that her baby may be at risk for Prader-Willi syndrome. But NIPS tests for rare conditions like Prader-Willi syndrome often incorrectly predict illness, and this proved to be the case for this woman. A follow-up invasive procedure showed that her NIPS test result was a false positive and she delivered a healthy baby.   

NIPS tests are a type of medical device called laboratory-developed tests (LDTs). They differ from conventionally manufactured tests in that they are developed and used in one laboratory. Although the U.S. Food and Drug Administration has the clear authority to review these tests for safety and effectiveness, it has chosen not to do so to date. In part, this is because these tests were once small in number and used on few patients. However, with recent advances in science and technology, companies are increasingly offering them for more common conditions. Consequently, the FDA is not even aware of the vast number of LDTs on the market and their safety and effectiveness, and many, including some for COVID-19, have been found to be inaccurate.

The Verifying Accurate Leading-edge IVCT Development Act of 2021 (VALID) offers a solution – albeit imperfect – to unreliable LDTs. Its risk-based framework would ensure that the highest-risk tests are properly vetted by the FDA for their safety and effectiveness. It would also give FDA the authority to require test developers to conduct surveillance of higher-risk tests on the market if it identifies problems with a test’s performance.

Congress had the chance to pass VALID when it was included in legislation that funds FDA, which needed to pass by the end of September. Instead, Congress passed a “clean” Continuing Resolution that left out all LDT provisions.

Now Congress has another chance to include the provisions in VALID when the Continuing Resolution expires on December 16. In an opinion piece published in MedPage Today, we urge Congress to pass legislation that will protect consumers before this window of opportunity slams firmly shut.