Loading
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.
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).
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.
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Aid in the decision for prostate biopsy, men 45 and older with abnormal PSA and/or rectal examination (PMA P190022) |
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Query for this drug: (TITLE:"4Kscore Test" OR ABSTRACT:"4Kscore Test" OR TITLE:"OPKO Health" OR ABSTRACT:"OPKO Health" OR TITLE:"4Kscore" OR ABSTRACT:"4Kscore" OR TITLE:"4K score" OR ABSTRACT:"4K score") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about 4Kscore Test (OPKO Health), not a curated reading list.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/