Opko Health said this week that is has begun a multi-center clinical validation study to support the launch of its 4Kscore protein biomarker prostate cancer test.
The company has begun enrolling patients at the first of 13 US-based clinical sites with the goal of enrolling more than 1,200 subjects over the next few months and plans to launch the test in the first quarter of 2014, David Okrongly, president of Opko Diagnostics, said in a statement.
Intended for use in predicting the likelihood that a patient has prostate cancer prior to a biopsy, the 4Kscore test uses 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 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 and have been tested in more than 10,000 patients to date, Opko said. The company launched sales of the test in Europe last year through its partner International Health Technology (PM 10/5/2012).
Opko plans to sell the test in the US through its Nashville, Tenn.-based CLIA lab.
The 4Kscore test "is expected to be an important tool in the fight against prostate cancer and the prevention of unnecessary biopsies," Peter Scardino, chair, department of surgery, at Memorial Sloan Kettering Cancer Center and one of the inventors of the test, said in a statement. "We are optimistic that the newly initiated clinical study will prospectively demonstrate for U.S.-based clinicians and payers the value of the 4Kscore test as an important guide in managing patients."