OPKO Health, a multinational pharmaceutical and diagnostics company, has commenced a pivotal, multi-center clinical validation study for the company’s 4Kscore test for the prediction of prostate cancer prior to prostate biopsy.
The 4Kscore test is based on over a decade of research of a four kallikrein panel of biomarkers conducted by scientists at Memorial Sloan Kettering Cancer Center and leading research centers in Europe on over 10,000 patients.
The OPKO multi-center study is expected to generate data to support the launch of the 4Kscore test as a laboratory developed test through the company’s CLIA laboratory in Nashville.
The company has begun enrolling patients at the first of 13 sites across the US and is planning to enroll more than 1,200 patients referred for a prostate biopsy over the course of the next few months.
OPKO chairman and CEO Dr Phillip Frost said: "We believe OPKO’s 4Kscore™ test will address a significant unmet medical need for better tests to identify men at risk for aggressive prostate cancer, while at the same time avoiding unnecessary, costly, and potentially harmful treatments."
OPKO Diagnostics president Dr David Okrongly noted the clinical study with over 15 of the leading and largest urology centers across the US is the last step before our commercial launch of the 4Kscore in the first quarter of 2014.
"The data we generate in this clinical study will not only be used for the required CLIA validation, but will also provide important data for securing 4Kscore™ reimbursement," added Okrongly.