{"entity":{"id":"progensa-pca3","kind":"drug","name":"Progensa PCA3 Assay","aka":["PCA3 urine test","Progensa"],"tldr":"The first urine RNA test for prostate cancer approved in the United States; its approval has since been withdrawn, though Medicare still lists it.","summary":"The FDA approved the Progensa PCA3 Assay (PMA P100033, Gen-Probe) on 13 February 2012 to measure PCA3 and PSA RNA in post-examination first-catch urine; the FDA database records a withdrawal date of 12 April 2023. Palmetto MolDX billing article A58700 still lists the Progensa PCA3 assay (CPT 81313) after a negative biopsy.","status":"withdrawn","asOf":"2026-11-04","links":[{"label":"FDA PMA P100033","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100033"},{"label":"CMS article A58700: Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer","url":"https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58700"}],"tags":["test","rna"],"related":["exodx-prostate"],"cancers":["prostate"],"sections":[],"technologies":["liquid-rna-biopsy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Progensa PCA3","modality":"Urine RNA test (PCA3 and PSA RNA, after a negative biopsy)","mechanism":"Nucleic acid amplification measures PCA3 and PSA RNA in first-catch urine collected after a digital rectal examination and reports their ratio.","approvals":[{"region":"US","year":2012,"indication":"FDA PMA approval (P100033) of a urine PCA3 RNA test to aid the decision on repeat biopsy for prostate cancer; withdrawn 12 April 2023"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/progensa-pca3/","neighbours":{"drug":[{"id":"exodx-prostate","kind":"drug","name":"ExoDx Prostate (IntelliScore)","route":"/drugs/exodx-prostate/"}],"cancer":[{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"liquid-rna-biopsy","kind":"technology","name":"Liquid RNA biopsy (cell-free, vesicle and platelet RNA)","route":"/technologies/liquid-rna-biopsy/"}]}}