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OPKO Health Acquires Next Generation Prostate Cancer Tests

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OPKO Health, Inc. yesterday announced the acquisition of an exclusive license from Arctic Partners Ab Oy (Turku, Finland) for two biomarkers in the kallikrein family which, used together with prostate specific antigen (PSA), can reduce the need for prostate biopsies by over 50%. These novel biomarkers were developed by investigators at the University of Malmo, Sweden, University of Turku, Finland, and Memorial Sloan Kettering Cancer Center, New York. The research results indicate that these markers can predict initial biopsy results in men suspected of having prostate cancer; they have been tested in over 8,000 men and were independently validated in the European Randomized Study of Prostate Cancer Screening (Rotterdam).

The value of PSA testing in men who would otherwise not be screened was assessed in the European Randomized Study of Prostate Cancer. Approximately 182,000 men in seven European countries were randomized for PSA screening or to serve as controls. At a median follow-up of approximately 9 years, PSA screening was associated with a 20% reduction in deaths from prostate cancer. Despite this finding, it is noted that 48 men would need to be treated to prevent one death from prostate cancer. While quite specific to the prostate gland, PSA is not specific for prostate cancer. As a result, in the U.S., an estimated 750,000 men receive unnecessary prostate biopsies annually. The OPKO test panel will combine PSA and two novel kallikrein markers to provide significantly greater accuracy.

“These two new biomarkers provide us with a unique opportunity to greatly improve the value of prostate cancer screening. The higher specificity of our new panel of markers will provide better and more efficient outcomes, while lowering overall costs,” said Phillip Frost, M.D., Chairman and CEO of OPKO Health.

“As a physician who sees many men with elevated PSA levels, I believe this novel panel of kallikrein biomarkers will help us to greatly reduce the number of unnecessary prostate biopsies performed with their attendant side effects and added costs. The research supporting the value of this panel is sound, and has been validated in thousands of patients in different clinical settings, including initial PSA screening, repeated screenings, and in men with a previous negative biopsy. I believe this panel of tests will eventually replace PSA measures alone for the early detection of prostate cancer that needs to be treated, helping us to avoid dealing with small, indolent cancers that should be left alone,” said Peter Scardino, M.D. (Chief of Surgery, Memorial Sloan Kettering Cancer Center, New York).

Source: OPKO