OPKO Health (OPK) Reports Publication of Positive 4Kscore Test Data

November 10, 2014 8:38 AM EST

OPKO Health (NYSE: OPK) announced the online publication of a multi-institutional, prospective study of the 4Kscore Test in the journal European Urology. The results of the study demonstrated that the 4Kscore provides a patient with accurate and personalized information about their risk of having Gleason Score ≥7 prostate cancer, making it a useful tool for selecting men who have significant disease and are most likely to benefit from a prostate biopsy.

“The clinical validation of the 4Kscore Test has confirmed the accuracy of the 4Kscore Test to identify men harboring a high grade prostate cancer in a diverse United States population,” said Dr. Dipen Parekh, Professor and Chair, Department of Urology at the University of Miami and principal investigator for the study. “The results confirm that the 4Kscore Test addresses an important need by providing urologists and their patient a calibrated, individual score for a patient’s risk of aggressive prostate cancer and thus provides information useful in the shared decision making discussion between Urologists and patients on whether to undergo a prostate biopsy.”

“The United States clinical validation confirms prior work published on multiple cohorts of men that were part of the European Research Study on Prostate Cancer Screening (ERSPC) using the same biomarkers used in the 4Kscore Test,” said David Okrongly, President of OPKO Diagnostics. “We are continuing to analyze the patient data coming from our U.S. clinical validation study, in particular to look at associations between the 4Kscore and pathology outcomes in both biopsy and radical prostatectomy specimens.”



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