The Science Behind
The 4Kscore® Test
The 4Kscore® Score Test is FDA-approved, and its accuracy has been demonstrated in two multi-center prospective validation studies in the United States.
![Representation of the US]](https://www.4kscore.com/wp-content/uploads/sites/68/2026/03/map1-1.gif)
A Multi-institutional Prospective Trial in the USA Confirms that the 4Kscore Test Accurately Identifies Men with High-grade Prostate Cancer
Parekh et al. Eur Urol. 2015;68:464-470.
- 1012 men prospectively enrolled in 26 academic and community practices
- Subjects had scheduled prostate biopsy as recommended by a urologist and blood drawn prior to biopsy
- Minimum of 10 core TRUS-guided biopsies performed on all patients
- AUC = 0.82
- 36% of biopsies could be avoided or delayed
![Representation of the US]](https://www.4kscore.com/wp-content/uploads/sites/68/2026/03/map2-1.gif)
A Multi-Institutional Prospective Trial Confirms Noninvasive Blood Test Maintains Predictive Value in African American Men
Study Results Show The 4Kscore Test Performance at 5.0 Cut-Point in the African American Population Identifies Men with High-Grade Prostate Cancer with 99% Sensitivity and 95% Negative Predictive Value (The 4Kscore Test PI)
Punnen et al. J Urol. 2018;199(6):1459-1463.
- 8 Veterans Affairs Hospitals
- 56% of the 366 men were African American
- Similar 4Kscore performance to first validation study
- No significant difference in 4Kscore accuracy between African American and non-African American men
- Sensitivity of 97% and Negative Predictive Value (NPV) of 95% for the detection of aggressive prostate cancer