Critical Path Institute’s Polycystic Kidney Disease Outcomes Consortium Secures FDA Qualification For Enrichment Biomarker In Autosomal Dominant Polycystic Kidney Disease (ADPKD)

TUCSON, Ariz.--(BUSINESS WIRE)--The Critical Path Institute (C-Path) announced today that the U.S. Food and Drug Administration (FDA) has issued a qualification decision in the form of a draft guidance to C-Path’s Polycystic Kidney Disease Outcomes Consortium (PKDOC) for total kidney volume (TKV) as a prognostic biomarker to select patients for clinical trials of new therapies for Autosomal Dominant Polycystic Kidney Disease (ADPKD).

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