OPKO Health, Inc

4Kscore Test

The 4Kscore® Test is used by health care professionals to improve the accuracy of prostate cancer diagnosis after an abnormal prostate-specific antigen (PSA) test result, or digital rectal exam, before the decision is made to biopsy. The 4Kscore® Test provides a risk score (4KScore) for finding aggressive prostate cancer based on combined serum concentrations of four prostate specific kallikrein proteins, and a subject’s clinical information, using a validated, proprietary algorithm. The 4Kscore® Test has been well studied, and published data have shown the stratification of men with elevated PSA and high 4Kscore to relative long term risk for prostate cancer, mortality, or prostate cancer metastasis 15-20 years out. The 4Kscore® Test has been demonstrated in prospective controlled clinical trials to have 95% sensitivity and 93% negative predictive value for aggressive prostate cancer prior to prostate biopsy with reduction in un-necessary prostate biopsies by 26-38%. This test is offered by OPKO’s own clinical laboratories as Laboratory Developed Test (LDT).