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# Congress Should Pass VALID Act on LDTs: Advocates
- URL: https://www.fdaweb.com/congress-should-pass-valid-act-on-ldts-advocates/
- Published: 2022-11-30T12:00:00.000Z
- Updated: 2026-09-14T18:08:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153289

Friends of Cancer Research CEO **Jeff Allen** and American Cancer Society Action Network president **Lisa Lacasse** say Congress should pass the VALID (Verifying Accurate Leading-edge IVCT Development) Act to “set a clear, modernized regulatory framework to ensure that any test, no matter where it is developed, meets the same quality and performance standards.” Writing in a *Stat News* online [post](https://www.statnews.com/2022/11/30/valid-act-improve-standards-lab-tests-precision-medicine/?utm%5Fcampaign=rss&ref=fdaweb.com), Allen and Lacasse say the bipartisan [bill](https://www.congress.gov/bill/117th-congress/house-bill/4128/text?q=%7B%22search%22%3A%5B%22valid+act%22%5D%7D&r=1&s=1&ref=fdaweb.com) allows for continued innovation by providing detailed flexibilities that will ensure labs can still meet individual patient needs without delaying patient care.

The two say the ongoing development of precision medicine to treat cancers emphasizes the need for accurate diagnostic tests. “Oversight of such tests has not kept pace with innovation,” they write.

According to the post, FDA currently regulates and ensures only the accuracy of tests used in multiple laboratories or healthcare facilities. Those designed for only a single laboratory, known as laboratory-developed tests (LDTs), are left to meet less stringent standards, the writers say. “That means,” they say, “a growing number of lab tests, including those used to determine cancer treatment for a specific patient, are offered without assurances that they work.”

The post cites a [study](https://academic.oup.com/ajcp/article/157/4/628/6454342?login=false&ref=fdaweb.com) published in the *American Journal of Clinical Pathology* which reported that LDTs offered for the same intended use as an FDA-approved test had significant variability in their results. “Errors in tests, including false negatives (when the test inaccurately states the genetic marker is not present), may impede patients’ access to safe and effective treatments for their cancers,” the authors say.