Infectious disease laboratory-developed tests (ID LDTs) should be permitted to rely on the same clinical validations previously proven to the agency via commercial tests already marketed for high-risk diseases, three clinical groups urged FDA Commissioner Robert Califf in an April 27 letter.
The Infectious Diseases Society of America, along with the American Society for Microbiology and the Pan American Society for Clinical Virology, argued to the agency that ID LDTs need a quicker pathway to approval than would
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