2023-06-08 09:56:15 ET
The Food and Drug Administration (FDA) is moving to more tightly regulate a class of laboratory-developed tests designed to detect conditions such as cancer and cholesterol, The Wall Street Journal r eported Thursday, citing people familiar with the plans.
The regulator is preparing a draft proposal to ensure that the tests perform as intended and are accurate, the people said, without disclosing when the proposal would be ready.
During the pandemic, lab-developed PCR tests regulated by the FDA helped detect COVID-19. Unlike traditional lab tests and FDA-approved machines or kits, the agency does not usually regulate lab-developed tests.
Those tests are conducted by academic institutions as well as public companies such as Laboratory Corporation of America ( NYSE: LH ) and Quest Diagnostics ( NYSE: DGX ). According to Grand View Research, lab-developed tests account for about half of all tests conducted in professional labs.
“If the regulations become too burdensome, this could limit a lab’s ability to provide those tests,” WSJ reported quoting Shannon Haymond, president of the American Association for Clinical Chemistry, a group of more than 8,500 lab professionals.
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FDA to more closely regulate lab-developed tests – WSJ