Date: 2015-04-21
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in the Journal of the National Cancer Institute
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 - Diagnostic
Country: UK
Trial
details: The Prostate Testing for Cancer and Treatment (ProtecT) study is a prospective randomized controlled trial conducted in the United Kingdom for the purpose of evaluating the cost effectiveness of conventional treatments in PSA-detected, clinically localized prostate cancer. Of the 82,428 men recruited for the trial, a total of 6129 men with elevated PSA (≥3.0 ng/mL) who underwent prostate biopsy and provided an adequate blood sample were tested for the four kallikreins and their 4Kscore result was determined.
Latest
news: * On April 21, 2015, Opko Health announced the online publication of a study entitled \"Predicting High-Grade Cancer at Ten-Core Prostate Biopsy Using Four Kallikrein Markers Measured in Blood in the ProtecT Study\" in the Journal of the National Cancer Institute . The study shows that the four kallikrein panel of biomarkers utilized in the OPKO 4Kscore® Test (Total PSA, Free PSA, Intact PSA and hK2) accurately identifies risk for aggressive prostate cancer prior to prostate biopsy. The Prostate Testing for Cancer and Treatment (ProtecT) study showed that the four kallikrein panel enhanced aggressive prostate cancer detection compared with PSA and age alone. The area under the curve (AUC) for the 4K model was 0.820 (95% CI = 0.802 to 0.838) while the PSA model was 0.738 (95% CI = 0.716 to 0.761) for high-grade cancer.
