Opko Health said this week it has acquired an exclusive license from Finnish biotech firm Artic Partners for two biomarkers from the kallikrein protein family that could be used to diagnose prostate cancer.
The biomarkers were identified by researchers at Sweden's University of Malmo, Finland's University of Turku, and New York's Memorial Sloan Kettering Cancer Center, who showed that the markers, in combination with prostate specific antigen, could predict initial biopsy results in men suspected of having prostate cancer.
The researchers tested the markers in more than 8,000 men, and the markers were independently validated in the European Randomized Study of Prostate Cancer Screening.
Although PSA is commonly used as a prostate cancer biomarker, it is not specific for the disease, leading to an estimated 750,000 unnecessary prostate biopsies in the US annually. The Opko test will combine PSA with the two kallikrein markers "to provide significantly greater accuracy," the company said in a statement.
A study published in BMC Medicine in 2008 showed that the addition of the markers improved the predictive value of a standard clinical prostate cancer exam – consisting of age, PSA measurement and a digital rectal exam – to an area under the curve of .84 from an AUC of .72.
"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," Phillip Frost, Opko's chairman and CEO, said in a statement.
"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," added Peter Scardino, chief of surgery at MSKCC and one of the investigators who identified the markers. "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."