Verified discoveries, trials, and approvals for this cancer type. Every story separates evidence strength, regulatory status, and guideline position.
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…
Primary source cited
Last reviewed
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…
Primary source cited
Last reviewed
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…
Primary source cited
Last reviewed
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…
Primary source cited
Last reviewed
Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.
Validation and three years of clinical experience in using an artificial intelligence algorithm as a second read system for prostate cancer diagnosis -- real-world experience (Modern Pathology). PMID 38868487.
Applies to the exact indication stated.
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…
Primary source cited
Last reviewed
CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.