Statement from Dr. Diana Zuckerman Regarding the FDA Final Rule on Regulation of Lab Developed Tests
April 29, 2024: We strongly support today’s FDA's decision to regulate lab-developed tests. Unfortunately, FDA’s final rules has compromised on the critical issue of grandfathering thousands of tests on the already on the market.
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April 29, 2024
Statement of Diana Zuckerman, Ph.D., President, National Center for Health Research
Washington D.C. – We strongly support FDA’s decision to regulate lab-developed tests because it is unconscionable that thousands of tests are currently being used by patients and consumers that have never been evaluated by independent experts to make sure they are accurate. Unfortunately, FDA’s final rule has compromised on a crucial issue — it “grandfathers” the thousands of tests – some dangerously inaccurate – that are already on the market, rather than requiring them to be proven to accurately diagnose serious medical conditions or genetic vulnerabilities. For example, a test that purports to tell a couple if their baby has a deadly genetic defect or that warns an adult that they are likely to develop breast cancer or stomach cancer may be wrong, resulting in parents aborting a wanted baby or the removal of a breast or stomach that would never have become cancerous. The previously proposed version of this LDT rule did not have that giant, deadly loophole – a loophole that was also in the VALID Act that Congress had considered on lab-developed tests. We are disappointed that the FDA did not stay with the stronger version that they had proposed just a few weeks ago.”because it is unconscionable that thousands of tests are currently being used by patients and consumers that have never been evaluated by independent experts to make sure they are accurate. Unfortunately, FDA’s final rule has compromised on a crucial issue — it “grandfathers” the thousands of tests – some dangerously inaccurate – that are already on the market, rather than requiring them to be proven to accurately diagnose serious medical conditions or genetic vulnerabilities. For example, a test that purports to tell a couple if their baby has a deadly genetic defect or that warns an adult that they are likely to develop breast cancer or stomach cancer may be wrong, resulting in parents aborting a wanted baby or the removal of a breast or stomach that would never have become cancerous. The previously proposed version of this LDT rule did not have that giant, deadly loophole – a loophole that was also in the VALID Act that Congress had considered on lab-developed tests. We are disappointed that the FDA did not stay with the stronger version that they had proposed just a few weeks ago.
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