The Pew Charitable Trusts wrote to the U.S. House and Senate sponsors of the Verifying Accurate Leading-edge IVCT Development (VALID) Act on Aug. 23 recommending changes intended to ensure that patients are protected under the proposed regulatory framework for in vitro clinical tests (IVCTs), which analyze blood, tissue, and other human samples. The legislation, introduced in June, seeks to bring all diagnostic tests under one risk-based review system, but the letter from Pew experts says the current structure does not strike an appropriate balance between enabling rapid market entry for diagnostic tests and ensuring patient safety.
Pew’s comments identify key ways to strengthen the legislation so that consumers and their health care providers can benefit from innovative tests and trust the accuracy of the results. The recommendations call for updating the language to:
- Ensure that exemptions from premarket review are risk-based and carefully defined.
- Establish a pilot program, subject to evaluation, for the new proposed technology certification review pathway before imposing an untested system on a large proportion of the diagnostics market.
- Protect the Food and Drug Administration’s ability to act when it becomes aware of a test on the market that may pose a risk to public health.
- Provide adequate resources to allow FDA to effectively oversee the diagnostics market.