Date: 2014-11-10
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in the journal European Urology
Company: OPKO Health (USA - FL)
Product: 4Kscore Test
Action
mechanism: The 4Kscore is a blood test that accurately identifies risk for aggressive prostate cancer. The 4Kscore 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 negative biopsy status (yes / no) using a proprietary algorithm to calculate the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore Test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions. The 4Kscore Test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the shared decision making discussion between a Urologist and patient. The 4Kscore Test was developed and validated by OPKO Lab in a 1,012 patient blinded, prospective study in the U.S. in 2014.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On November 10, 2014, OPKO Health announced the online publication of a multi-institutional, prospective study of the 4Kscore Test in the journal European Urology. The results of the study demonstrated that the 4Kscore provides a patient with accurate and personalized information about their risk of having Gleason Score ≥7 prostate cancer, making it a useful tool for selecting men who have significant disease and are most likely to benefit from a prostate biopsy. \"The clinical validation of the 4Kscore Test has confirmed the accuracy of the 4Kscore Test to identify men harboring a high grade prostate cancer in a diverse United States population,\" said Dr. Dipen Parekh , Professor and Chair, Department of Urology at the University of Miami and principal investigator for the study. \"The results confirm that the 4Kscore Test addresses an important need by providing urologists and their patient a calibrated, individual score for a patient\'s risk of aggressive prostate cancer and thus provides information useful in the shared decision making discussion between Urologists and patients on whether to undergo a prostate biopsy.\" \"The United States clinical validation confirms prior work published on multiple cohorts of men that were part of the European Research Study on Prostate Cancer Screening (ERSPC) using the same biomarkers used in the 4Kscore Test,\" said David Okrongly , President of OPKO Diagnostics . \"We are continuing to analyze the patient data coming from our U.S. clinical validation study, in particular to look at associations between the 4Kscore and pathology outcomes in both biopsy and radical prostatectomy specimens.\"
