The 4Kscore is the only blood test that accurately identifies risk for aggressive prostate cancer.

1. The 4Kscore® blood test for
risk of aggressive prostate cancer

2. Early detection of aggressive prostate cancer
Challenges
• Serum PSA has a high false positive rate
• Over 1 million prostate biopsies performed annually in US
• 75% biopsies will have low-grade, indolent (Gleason 6) or no prostate cancer
• Serious complications of biopsies include infection and hospitalization
• Overtreatment- 67% of Gleason 6 indolent cancers at prostate biopsy are
confirmed at radical prostatectomy
• Recommendation by USPSTF to stop PSA screening misses an opportunity to
detect and treat men with high grade (Gleason ≥7), the aggressive form of
prostate cancer

3. The 4Kscore Test
• The only blood test that accurately identifies risk for aggressive prostate
cancer
• Aggressive prostate cancer is defined by both high-grade disease and long
term clinical outcomes (rate of prostate cancer metastases)
• Based on 10 years of work by scientists at Memorial Sloan-Kettering
Cancer Center and evaluated in over 22,000 men in 12 clinical studies and
validated in a prospective, blinded prebiopsy study of 1,012 men in US
• Included in the 2015 NCCN Guidelines for Prostate Cancer Early
Detection

4. 2015 NCCN Prostate Cancer Early Detection Guidelines

5. What is the 4Kscore Test?
Components Results
Total PSA
Free PSA
Intact PSA
hK2
+ Age, DRE, and
prior biopsy status
Proprietary
to OPKO {
OPKO ALGORITHM
% risk of having
aggressive prostate
cancer for an
individual patient

6. 4Kscore Test: 10 years of clinical research conducted by Memorial Sloan Kettering Cancer
Center and leading international cancer centers

7. Prospective, blinded, multicenter US study
validates 4Kscore Test
• 1,012 patients enrolled in 26 academic
and community practices
• Referred for biopsy regardless of age,
PSA, clinical findings or prior biopsy status
• Minimum of 10 core TRUS-guided
biopsies performed
• The 4Kscore Test was performed at
OPKO Lab, Nashville, TN
• Pathology conducted according to the
established practice at each center
• Presented in the 2014 AUA Plenary Session
and published in European Urology
(http://dx.doi.org/10.1016/j.eururo.2014.10.0
21) Epub Ahead of Print
26 Clinical study sites

8. Gleason score distribution in Prospective US Study
Negative or Gleason 6
prostate cancer
Aggressive
(Gleason ≥ 7)
prostate cancer

9. The 4Kscore Test has the greatest accuracy for predicting aggressive
prostate cancer
Sensitivity
1 - Specificity
AUC = 0.5
4Kscore
AUC = 0.82 1
AUC = area under the curve
Larger AUC = better accuracy
for predicting aggressive
prostate cancer
PSA
AUC = 0.69 1
AUC of other tests when
applied to aggressive disease
PHI = 0.72, 0.67 2,3
PCA3 = 0.68 4
1. Parekh, D et al. http://dx.doi.org/10.1016/j.eururo.2014.10.021(Epub Ahead of Print)
2. Catalona et al. J Urol. 185:1650 2011
3. Wang, W et al. Scientific Reports 4:1-8 2014
4. Chevli, K et al. J Urol 191:1743 2014

10. The risk of aggressive prostate cancer predicted by the
4Kscore Test is confirmed by prostate biopsy
239 aggressive
prostate cancers
detected in 1,012
subjects

11. 4Kscore Test is more accurate than total PSA alone in predicting
aggressive prostate cancer in subset of men with PSA 16-20ng/mL

12. Improving the Specificity of Screening for Lethal Prostate Cancer Using Prostate-specific Antigen and a Panel of Kallikrein Markers:
A Nested Case–Control Study Stattin, P et al. http://dx.doi.org/10.1016/j.eururo.2015.01.009(Epub Ahead of Print)
4Kscore Test Biomarkers
> 7.5% (N =1510, 62%)
4Kscore Test Biomarkers
 7.5% (N = 922, 38%)
5 year
10 year
15 year
20 year
= 2.4%
= 5.6%
= 9.9%
= 16.4%
5 year
10 year
15 year
20 year
= 0%
= 0.2%
= 1.0%
= 1.8%
4Kscore
> 7.5%
all men
PSA ≥ 3
4Kscore
≤ 7.5%
all men PSA ≥ 3
The 4Kscore Test predicts the probability of distant metastases
within 20 years

13. Clear result reporting for informed decision making
4Kscore =
Personal Positive Predictive Value

14. The 4Kscore Test Summary
• Included in the 2015 NCCN Guidelines for Prostate Cancer Early Detection
• Clinical utility was validated based on a decade of research in over 22,000 men in
Europe and the United States
• Identifies the risk of aggressive prostate cancer for the individual patient
• High grade prostate cancer pathology
• Poor prostate cancer clinical outcomes within 20 years
• Has high sensitivity and high negative predictive value for aggressive prostate cancer
The only blood test that accurately identifies risk for aggressive prostate cancer