OPKO Health, Inc. (NYSE: OPK) has commenced a pivotal, multi-center clinical validation study for the Company’s proprietary 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, TN. The Company has begun enrolling patients at the first of 13 sites across the United States and is planning to enroll more than 1,200 patients referred for a prostate biopsy over the course of the next few months.
“The OPKO Lab 4Kscore™ test is expected to be an important tool in the fight against prostate cancer and the prevention of unnecessary biopsies,” said Dr. Peter Scardino, Chair, Department of Surgery, Memorial Sloan Kettering Cancer Center. “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.”
According to a paper titled “The Kallikrein Panel for Prostate Cancer Screening: Its Economic Impact”, published online October 26, 2013 in the journal The Prostate, it is estimated that about $1 billion in healthcare costs could be saved annually in the U.S. by implementing a four kallikrein panel test and using the results of the test to determine if a prostate biopsy should be performed.
“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,” said Phillip Frost, M.D., OPKO's Chairman and Chief Executive Officer.