On March 15, 2016 OPKO Health, Inc. (NYSE:OPK) reported the decision of the European Association of Urology (EAU) Prostate Cancer Guidelines Panel to include the 4Kscore Test in the 2016 EAU Guidelines for Prostate Cancer (Press release, Opko Health, MAR 15, 2016, View Source [SID:1234509564]). The panel concluded that the 4Kscore, as a blood test with greater specificity over the PSA test, is indicated for use prior to a first prostate biopsy or after a negative biopsy to assist patients and physicians in further defining the probability of high-grade cancer.

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"The EAU Prostate Cancer Guidelines Panel is an international, multi-disciplinary group of specialists in prostate cancer diagnosis and treatment," said Dr. Alberto Briganti, Department of Urology, San Raffaele Scientific Institute, Milan, Italy. "The decision to include the 4Kscore in the guidelines indicates that the Panel views the 4Kscore Test as having achieved an appropriate level of clinical evidence to recommend its use for both assessment of asymptomatic men prior to a first prostate biopsy and as an additional investigational test to be done after a negative prostate biopsy."

The 4Kscore test has been studied on over 22,000 patients with results published in 12 peer-reviewed scientific publications. The 4Kscore test is the only blood test that accurately identifies an individual patient’s risk for high-grade, aggressive cancer.

About the 4Kscore Test

The 4Kscore, a laboratory developed test, is the only blood test that accurately identifies an individual patient’s risk for aggressive prostate cancer, the lethal form of prostate cancer. The 4Kscore test uses a proprietary algorithm that incorporates the blood levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein-2 (hK2), plus the patient’s age, and other clinical information to calculate the percentage risk (probability) of finding a Gleason Score 7 or higher grade of prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore Test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions and is included as a standard of care in both the 2016 NCCN Early Detection Guidelines and the 2016 EAU Guidelines for prostate cancer. The 4Kscore test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the shared decision making discussion between the Urologist and the patient.