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Clinical Groups Call For 'Me-Too' Pathway For Infectious Disease LDT Approvals

A group of infectious disease and clinical virology societies are asking FDA to establish an alternative under the agency's proposed lab-developed test framework for infectious disease test services. Clinical laboratories should be able to use commercial high-risk tests as predicates for ID LDTs so they won't have to go through the costly PMA submissions process.

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...

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