{"entity":{"id":"4kscore","kind":"drug","name":"4Kscore Test (OPKO Health)","aka":["4K score","4Kscore"],"tldr":"A blood test that estimates the chance that a biopsy would find an aggressive prostate cancer, approved by the FDA in December 2021 for men 45 and older with an abnormal PSA or examination.","summary":"The 4Kscore Test (OPKO Health, PMA P190022) was approved by the FDA on 7 December 2021. It combines four immunoassays (Roche Elecsys total PSA and free PSA, intact PSA and human kallikrein 2) with the patient's age, previous biopsy and digital rectal examination into a single score, and is indicated \"as an aid in the decision for prostate biopsy in men 45 years of age and older who have an abnormal age-specific total PSA and/or abnormal DRE\", to aid detection of Gleason Grade Group 2 or higher cancer. In the approval order a 4Kscore below 5.0 is associated with a decreased likelihood of a Gleason score of 7 or more on biopsy; the test is not recommended more than once every six months and is performed at a single laboratory (BioReference Laboratories).","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA PMA P190022","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190022"}],"tags":["test","screening-test"],"related":["prostate-health-index","isopsa","fda-device-databases"],"cancers":["prostate"],"sections":["early-detection","diagnostics"],"technologies":["prostate-screening-psa-mri"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["psa","screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"4Kscore","modality":"Blood test combining four kallikrein measurements with clinical information","mechanism":"Combines total, free and intact PSA and human kallikrein 2 with age, previous biopsy and rectal examination findings into one score for the chance of an aggressive cancer.","approvals":[{"region":"US","year":2021,"indication":"Aid in the decision for prostate biopsy, men 45 and older with abnormal PSA and/or rectal examination (PMA P190022)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/4kscore/","neighbours":{"drug":[{"id":"isopsa","kind":"drug","name":"IsoPSA Assay (Cleveland Diagnostics)","route":"/drugs/isopsa/"},{"id":"prostate-health-index","kind":"drug","name":"Prostate Health Index (phi, Beckman Coulter)","route":"/drugs/prostate-health-index/"}],"collection":[{"id":"fda-device-databases","kind":"collection","name":"FDA medical device databases (PMA, 510(k), De Novo)","route":"/collections/fda-device-databases/"}],"cancer":[{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"prostate-screening-psa-mri","kind":"technology","name":"PSA and MRI-first prostate cancer screening","route":"/technologies/prostate-screening-psa-mri/"}],"term":[{"id":"psa","kind":"term","name":"PSA (prostate-specific antigen)","route":"/terms/psa/"},{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}]}}