The 4Kscore Test combines four prostate-specific kallikrein assay results with clinical information in an algorithm that calculates the individual patient's percent risk for aggressive prostate cancer. It is the most accurate test to assess a patient's risk for aggressive prostate cancer prior to a prostate biopsy. With the 4Kscore Test, physicians can more confidently choose to place a low-risk patient under active monitoring or perform a biopsy on a high-risk patient based on their clinical evaluation, enhanced by the 4Kscore Test result.
The 4Kscore Test has undergone extensive clinical development and confirmation. The biomarkers utilized in the 4Kscore Test are based on over a decade of research conducted by scientists at the Memorial Sloan Kettering Cancer Center and leading research centers in Europe, encompassing over 20,000 men in Europe and the United States. The results have recently been replicated in a prospective, blinded clinical study conducted at 26 urology centers across the United States on 1,012 patients.
The test has been shown to identify the actual risk of aggressive prostate cancer for the individual patient, including high grade prostate cancer pathology and poor prostate cancer clinical outcomes within 20 years, with both high sensitivity and negative predictive value for aggressive prostate cancer.