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pathologist-owned lab
Goodbye Clinical Labs! Hello Genetic Testing Labs!
By R. Lewis Dark | From the Volume XXVIII, No. 10 – July 26, 2021 Issue
IS THE CLASSIC MODEL OF THE INDEPENDENT PATHOLOGIST-OWNED CLINICAL LABORATORY that is the sole source provider of all routine, reference, and esoteric testing to physicians in its community on its way to extinction? There is strong evidence to support a “yes” answer to that question….
CURRENT ISSUE
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Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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