OPKO Health, Inc. (NYSE:OPK) today announced that the American Urological Association (AUA) has accepted “The 4Kscore TM Test as a Predictor of High-Grade Prostate Cancer on Biopsy” as a Late-Breaking Abstract for presentation in Plenary I on Sunday May 18, 2014 at the AUA Annual meeting in Orlando, FL.
The data accepted are from a prospective, blinded study conducted at 26 urology clinics across the United States from October 2013 to January 2014. The data confirm the accuracy of the 4Kscore TMalgorithm in a United States population of men referred for prostate biopsy. The 4Kscore TM algorithm, which is based on the values of four different kallikrein blood tests (total PSA, free PSA, intact PSA and hK2) plus age, DRE and prior biopsy status, was originally studied in multiple European cohorts involving over 10,000 patients.
“These are challenging times in urology as we are seeing a decline in men screened for prostate cancer with PSA, yet we know that mortality from prostate cancer has steadily declined since the introduction of PSA screening,” said Dr. Stephen M. Zappala, MD FACS of Andover Urology. “The 4Kscore TM test offers new information on the probability of having a Gleason Score ≥ 7 cancer prior to undergoing a prostate biopsy. This is important, because we know that besides the potential side effects of biopsy such as bleeding and infection, up to 80% of prostate biopsies will either be negative for prostate cancer or will indicate a low grade disease that may be better monitored than treated. The 4Kscore TM test will offer both the Urologist and patient new information for the shared decision-making discussion about whether or not to have a prostate biopsy.”
“Acceptance as a late-breaking abstract highlights both the quality of the clinical data for the 4Kscore TM test and the urgent need to have a solution for more effective biomarker-based tests for managing prostate cancer risk and the disease itself,” said David Okrongly, President of OPKO Diagnostics. “We are looking forward to presenting the full US clinical trial data at the AUA meeting in May.”“The results of the US clinical study are now complete and we are pleased to also announce that we are on track for launch of the 4Kscore Test on March 31, 2014,” said Phillip Frost, M.D., OPKO's Chairman and Chief Executive Officer.