OPKO Health, Inc., announced that its 4Kscore Test for aggressive prostate cancer (PC) was chosen by an expert panel of the European Association of Urology (EAU) to be included in the 2016 EAU Guidelines for Prostate Cancer. The panel decided that 4Kscore, a blood test, showed greater specificity than the prostate-specific antigen (PSA) test in determining the probability of high-grade prostate cancer, and its use was indicated prior to a first biopsy or after a negative biopsy.
“The EAU Prostate Cancer Guidelines Panel is an international, multi-disciplinary group of specialists in prostate cancer diagnosis and treatment,” Dr. Alberto Briganti, with the Department of Urology at San Raffaele Scientific Institute in Milan, Italy, said in a press release. “The decision to include the 4Kscore in the guidelines indicates that the Panel views the 4Kscore Test as having achieved an appropriate level of clinical evidence to recommend its use for both assessments of asymptomatic men prior to a first prostate biopsy and as an additional investigational test to be done after a negative prostate biopsy.”
The 4Kscore test identifying a patient’s risk for aggressive PC — the most life-threatening form of the disease — works by using a proprietary algorithm that includes the blood levels of four separate prostate-derived kallikrein proteins: total PSA, free PSA, intact PSA, and human kallikrein-2 (hK2). The test also incorporates a patient’s age and other relevant clinical data to measure with accuracy the likelihood of arriving at a Gleason Score 7 or higher PC grade, and so guide treatment options.
The panel of kallikrein biomarkers used in the test was developed by researchers at Memorial Sloan-Kettering Cancer Center in cooperation with European institutions. The 4Kscore Test is also regarded as a standard of care in the U.S., and included the 2016 NCCN Early Detection Guidelines for prostate cancer as well.
4Kscore has been studied in 22,000 patients, with peer-reviewed results published in 12 scientific journals, OPKO Health said in the release. More information on the 4Kscore Test is available on a company webpage.