Photo of a clinical lab professional preparing a lab developed test.
Adding this additional oversight would create an expensive and potentially contradictory regulatory environment.
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Medical Community Urging Congress to Remove the VALID Act

The VALID Act would block patients from accessing essential diagnostic tests

Photo portrait of Miriam Bergeret
Miriam Bergeret, MSc
Jun 06, 2022 | 1 min read

More than 100 medical and patient organizations are urging the United States Congress to remove the VALID Act from the FDASLA Act, an important bill that must soon be passed and enacted by Congress.

Passing the VALID Act would add FDA oversight to existing Centers for Medicare & Medicaid Services (CMS) oversight of laboratory developed tests (LDTs)—essential tests developed by individual clinical labs to fill gaps in testing where no commercially available FDA-approved test is available. 

Adding this additional oversight would create an expensive and potentially contradictory regulatory environment that would prevent many clinical labs from developing and using lab developed tests, affecting patient care, including genetic testing for newborns or pre-surgery tests for cancer patients, wrote the AACC in a recent press release.

In May, The Pew Charitable Trusts, National Center for Health Research, and Living Beyond Breast Cancer, among others, also sent a letter to Congress outlining “serious concerns about the current version of the legislation.”

The American Medical Association and the American Hospital Association have also both expressed concerns on the issue of laboratory developed test regulation.

According to AACC, passing the VALID Act would overwhelm the FDA, which does not currently have the resources to meet the demand of more than 132,000 annual submissions from more than 11,000 clinical laboratories in the US.

“The fact that all of these different organizations have issues with the VALID Act underscores that it is a deeply problematic piece of legislation that would cause significant patient harm,” wrote AACC. “We strongly advocate for the removal of VALID from the FDASLA Act so that Congress can assess VALID’s potential impact on patient care and correct its serious flaws.”