OPKO Health, Inc. (NYSE:OPK) announced the results of the data from its blinded, prospective clinical study of the 4Kscore Test at 26 leading Urology centers across the United States. The results demonstrated the 4Kscore Test is the most accurate, personalized predictor for risk of high-grade cancer. The data were presented by Dr. Daniel W. Lin, Professor and Chief of Urologic Oncology at the University of Washington, as a Late-Breaking abstract at the Plenary I Session on Sunday May 18, 2014 at the American Urological Association (AUA) annual meeting in Orlando, FL.
The 4Kscore Test, launched by OPKO on March 31, 2014, provides a patient with his personal risk for high-grade prostate cancer from a blood test. The measurements used in the 4Kscore Test are four kallikrein protein levels from the blood test (Total PSA, Free PSA, Intact PSA and hK2), along with the patient’s age, digital rectal exam (DRE) status, and prior biopsy status combined in an algorithm that provides a patient’s personal risk for high-grade cancer. The panel of biomarkers used in the 4Kscore has been tested in over 10,000 men by investigators at Memorial Sloan-Kettering Cancer Center and leading institutions participating in the European Randomized Study of Screening for Prostate Cancer (ERSPC).
OPKO, through its OPKO Lab division, developed and validated the 4Kscore Test. The clinical data presented at the AUA annual meeting included 1,012 men scheduled for prostate biopsy. Patients were enrolled regardless of their PSA, age, digital rectal exam (DRE) result, or primary versus repeat biopsy status, and represent contemporary practice in the United States. The results demonstrated the ability of the 4Kscore Test to discriminate between men with high-grade, aggressive prostate cancer and those men who had no findings of cancer or had low-grade disease. The discrimination, measured by Area Under the Curve (AUC) analysis, was 0.82 and was significantly higher than previously developed tests. Furthermore, the 4Kscore Test demonstrated excellent risk calibration, indicating the accuracy of the result for an individual patient. The high value of AUC and the excellent risk calibration make the 4Kscore result valuable information for the shared decision-making between the Urologist and patient on whether or not to perform a prostate biopsy, potentially reducing biopsies by 30-50%.