OPKO Health, a multinational biopharmaceutical and diagnostics company, has launched the 4Kscore Test through its CLIA-accredited OPKO Lab in Nashville, Tennessee. The laboratory-developed test is designed to enhance the prostate biopsy decision making process that, in the United States, leads to approximately 1 million biopsies being performed annually, with 80 per cent of the results indicating no cancer or a low-grade cancer. The 4Kscore Test will help to reduce unnecessary prostate biopsies by providing information on the risk (probability) of having high-grade prostate cancer.
The 4Kscore Test was developed by OPKO Lab, a division of OPKO Health, and tested in collaboration with 26 urology centres across the United States from October 2013 to March 2014. Results showed that the 4Kscore Test was highly accurate for predicting the presence of high-grade cancer (Gleason score 7 or higher) prior to prostate biopsy. The full data from the blinded, prospective US clinical validation study will be presented at the AUA Annual Meeting in Orlando, Florida on May 18th at Plenary Session I.
"We are pleased to offer the 4Kscore Test at OPKO Lab to provide urologists with new information to inform them of the risk of a patient's having high-grade prostate cancer and help clarify the decision process surrounding prostate biopsy," said David Okrongly, president of OPKO Diagnostics.
"We believe the 4Kscore Test will be an important benefit for Urologists and their patients and may lead to lower overall healthcare costs," said Phillip Frost, managing director, OPKO's chairman and chief executive officer.
The 4Kscore Test measures the blood plasma levels of four different prostate-derived kallikrein proteins Total PSA, Free PSA, Intact PSA and Human Kallikrein 2 (hK2). These biomarkers are combined with a patient's age, Digital Rectal Exam (DRE) status (nodule / no nodule), and prior biopsy status (yes / no) using a proprietary algorithm to calculate the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The 4Kscore Test was developed by OPKO Lab, a division of OPKO Health and will be performed at OPKO Lab's CLIA-accredited facility in Nashville, Tennessee. The four kallikrein panel of biomarkers utilised in the test is based on over a decade of research conducted by scientists at Memorial Sloan Kettering Cancer Centre and leading European institutions. The information provided by the 4Kscore Test can add new information to the shared decision making discussion between a Urologist and patient in determining the advisability of a prostate biopsy.
In 2014, over 233,000 new cases of prostate cancer will be identified and 29,480 men will die from the disease according to estimates released by the National Cancer Institute, making it the second most deadly cancer in US men. Prostate cancer is usually first detected by elevations in serum PSA. However, PSA level is often elevated for reasons unrelated to prostate cancer. Although an elevated PSA level often leads to biopsy, about 80 per cent
of all prostate biopsies performed are either negative or indicate a low likelihood of high-grade cancer.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialisation expertise and novel and proprietary technologies.