What is the 4Kscore® Prostate Cancer Biomarker Test?
Using a clinically validated algorithm, The 4Kscore® Test integrates results of Total PSA, Free PSA, Intact PSA, Human Kallikrein 2 (hK2) plus age, prior biopsy status, and DRE (if available), and generates a probability score of detecting Gleason ≥7 / Grade Group ≥2 prostate cancer on biopsy.
Clinical Utility
Improve Risk Stratification
The 4Kscore Test provides objective risk information beyond PSA alone, helping distinguish men who may benefit from biopsy from those who can be safely monitored.
Reduce Avoidable Biopsies
Studies demonstrate that the 4Kscore Test can help avoid upward of 30% of biopsies, depending on the risk threshold used, while preserving detection of aggressive disease.
Support Shared Decision-Making
The numeric risk output is intuitive for patients and aligns with guideline-driven discussions around benefits and harms of early detection.
Guideline Alignment
The 4Kscore Test is consistent with recommendations from leading professional organizations that endorse the use of secondary biomarkers prior to biopsy:
Both the NCCN Prostate Cancer Early Detection Guidelines and The AUA/SUO Early Detection of Prostate Cancer Guideline recognize kallikrein-based tests as tools that may improve specificity and reduce avoidable procedures.
Intended Use Population
The 4Kscore Test is indicated for men age 45 and above, prostate biopsy naive or had a prior negative biopsy, and meet the age-specific elevated PSA or abnormal DRE defined below:
Age-stratified PSA
45-54 years old: total PSA ≥ 2 ng/mL
55-75 years old: total PSA ≥ 3 ng/mL
≥76 years old: total PSA ≥ 4 ng/mL
OR
Suspicious nodule on DRE,
regardless of whether PSA is elevated
Contraindications
The 4Kscore Test is Not Indicated in Men With:
- Digital rectal exam (DRE) performed within 96 hours (4 days) before blood draw.
- Use of 5-alpha reductase medication within previous 6 months.
- Prostate procedures within the previous six (6) months. Procedures include, but are not limited to, prostate biopsy, thermotherapy, microwave therapy, laser therapy, Transurethral Resection of the Prostate (TURP), urethral catheterization, and lower genitourinary tract endoscopy.
Precautions
The 4Kscore Test is:
- For in vitro diagnostic use
- For use by healthcare professionals
- Prescription use only