OPKO Health Announces Landmark Study Showing 4Kscore® Test is Strong Predictor of Prostate Cancer Mortality Published in European Urology

OPKO Health, Inc. (NASDAQ:OPK) today announced that data from a landmark study of the 4Kscore® test entitled, “Twenty-year Risk of Prostate Cancer Death by Midlife Prostate-specific Antigen and a Panel of Four Kallikrein Markers in a Large Population-based Cohort of Healthy Men” were published online in the peer-reviewed journal, European Urology.

Prostate-specific antigen (PSA) testing can reduce death from prostate cancer but raises the risk of over diagnosis and over treatment of prostate cancer that is not life threatening. OPKO's 4Kscore test was designed to detect aggressive prostate cancer and reduce the use of prostate biopsy and it's associated risks in men with abnormal PSA.

The Malmö Diet and Cancer study enrolled 11,506 healthy men between the ages of 45 and 73 from 1991-1996 who had no previous PSA testing and very limited PSA testing following enrollment. When entering the study, a blood sample was cryopreserved and the men were followed through December 2014 when the blood samples were tested and patients who were diagnosed and died from prostate cancer identified. In the study, there were 317 deaths from prostate cancer. The 4Kscore was measured on 1,223 men diagnosed with prostate cancer and 3,028 controls.

The study found that men aged 60-73 with a PSA ≥2.0 ng/mL in their banked sample had a 7.7% (1 in 13) chance of dying from prostate cancer up to 15 years after the sample was collected. These same men were tested with the 4Kscore, and if the 4Kscore test result was ≥7.5%, indicating high risk for aggressive disease, the risk for death from prostate cancer in the next 15 years was increased to a 13% (1 in 8) chance.

The men with 4Kscore results ≥ 7.5 would have benefited from additional evaluation including possible biopsy. Men with a 4Kscore result < 7.5 have a respective risk of death from prostae cancer of 0%, 0.6% and 1.7% over the next 5, 10 and 15 years. So these men could have avoided biopsy and opted for continued monitoring.

The 4Kscore measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and hK2. These biomarkers are combined with a patient's clinical information using a proprietary algorithm that calculates the risk (probability) of finding a Gleason Score 7* or higher 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.

*Gleason score is based on how much the cancer looks like healthy tissue when viewed under a microscope. Less aggressive tumors generally look more like healthy tissue. Tumors that are more aggressive are likely to grow and spread to other parts of the body. They look less like healthy tissue. Gleason score 7 is medium grade cancer.

Opko Health is a diversified healthcare company with businesses in the diagnostics, drug development and manufacturing industries. Opko has made a number of acquisitions in recent years and they continue to explore acquisition opportunities.