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The FDA granted 510(k) clearance -- a real FDA regulatory action for a diagnostic device, distinct from the drug-approval pathway most other records on this site describe -- to Ibex…
Across two validation cohorts, an 18-gene urine test (MPS2) substantially outperformed PSA alone (AUC 0.81–0.82 vs. 0.60) for detecting higher-grade prostate cancer, with modeled reductions in unnecessary biopsies, including in…