Opko Health this week announced the launch of its 4Kscore prostate cancer test, which it will offer out of its Nashville, Tenn.-based CLIA lab.
Intended to aid clinicians in deciding if a prostate cancer is high risk and requires biopsy, the 4Kscore test analyzes four kallikrein protein markers – total prostate specific antigen, free PSA, intact PSA, and hK2 – combined with patient age and digital rectal exam status to determine the likelihood of aggressive disease.
The test was validated in a prospective multi-center study encompassing 26 urology centers across the US. The company plans to present data from this trial at the American Urological Association's annual meeting in May.
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 and have been tested in more than 10,000 patients to date, Opko said. The company launched the test in Europe in 2012 through its partner International Health Technology.