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A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests.
The suit, filed in a Texas federal court by the American Clinical Laboratory Association and PCR lab HealthTrackRx, claims the FDA does not have the authority to scrutinize lab-developed tests. When the FDA finalized its test regulation plan last month, several experts said it was only a matter of time until someone in the lab industry sued.
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Tests made in labs have historically gone unregulated by the FDA, as the agency considered them low-risk when it started regulating medical devices in 1976. But the tests have since become more numerous and complex, and the regulatory gray area enabled unreliable tests to thrive and harm patients. Infamous examples include Theranos’ blood tests, as well as misleading prenatal genetic tests from a range of companies.
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