# 4Kscore Test (OPKO Health)

Source: https://onco.cc/drugs/4kscore/  
OnCo record `4kscore` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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).

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-04
- Also known as: 4K score; 4Kscore
- Tags: test; screening-test
- 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: US 2021: Aid in the decision for prostate biopsy, men 45 and older with abnormal PSA and/or rectal examination (PMA P190022)

## Sources

- FDA PMA P190022: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190022

## Connected records

- drugs: [IsoPSA Assay (Cleveland Diagnostics)](https://onco.cc/drugs/isopsa/), [Prostate Health Index (phi, Beckman Coulter)](https://onco.cc/drugs/prostate-health-index/)
- collections: [FDA medical device databases (PMA, 510(k), De Novo)](https://onco.cc/collections/fda-device-databases/)
- cancers: [Prostate cancer](https://onco.cc/cancers/prostate/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [PSA and MRI-first prostate cancer screening](https://onco.cc/technologies/prostate-screening-psa-mri/)
- terms: [PSA (prostate-specific antigen)](https://onco.cc/terms/psa/), [Screening](https://onco.cc/terms/screening/)

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