OPKO Health, Inc., a multinational biopharmaceutical and diagnostics company, announced the decision of the National Comprehensive Cancer Network (NCCN) to include its 4Kscore as a recommended test in the 2015 NCCN guidelines for prostate cancer early detection.
The panel concluded that the 4Kscore, as a blood test with greater specificity over the PSA test, is indicated for use prior to a first prostate biopsy or after a negative biopsy to assist patients and physicians in further defining the probability of high-grade cancer.
"We are pleased that the NCCN, an organisation leading the way in the establishment of evidence-based guidelines for cancer diagnostics, is recommending the use of the 4Kscore test in the 2015 Prostate Cancer Early Detection Guidelines," said David Okrongly, Ph.D., president of OPKO Diagnostics.
The 4Kscore test has been studied on over 22,000 patients with results published in 12 peer-reviewed scientific publications. "Since its launch, I have been offering and using the 4Kscore test with my patients who have an abnormal PSA prior to a first prostate biopsy and before repeating a prostate biopsy after a negative biopsy," said Dr. Dipen Parekh, professor and chair, department of urology at the University of Miami and principal investigator for the recently published United States multicenter validation study.
"The 4Kscore provides me as a clinician with important information about my patient's individual risk for having aggressive prostate cancer and allows me to have an informed discussion with my patient about whether or not to proceed with a prostate biopsy or safely follow the patient."
The 4Kscore test is the only blood test that accurately identifies an individual patient's risk for high-grade, aggressive cancer. In arriving at their recommendations, the NCCN panel stated "The challenge is to minimise immediate treatment (over-treatment) of indolent cancers by accurately characterising the biology of the detected cancer. Identification and selective treatment of aggressive cancers should result in significant decreases in morbidity and mortality while limiting adverse effects on quality of life."
"OPKO is committed to the strategy that effective therapy, particularly cancer therapy, can be greatly enhanced by use of diagnostic tests," said Phillip Frost, M.D., OPKO's chairman and chief executive officer. "Through diagnostics, we can enable physicians to take a more targeted and precise approach in their treatment strategies and thus improve patient outcomes and lower overall healthcare costs."
The 4Kscore is the only blood test that accurately identifies an individual patient's risk for aggressive prostate cancer, the lethal form of prostate cancer. The 4Kscore uses a proprietary algorithm that incorporates the blood levels of four different prostate-derived kallikrein proteins--Total PSA, Free PSA, Intact PSA and Human Kallikrein-2 (hK2), plus the patient's age, Digital Rectal Exam (DRE) status (nodule / no nodule), and prior negative biopsy status (yes / no) to calculate the percentage risk (probability) of finding a Gleason Score 7 or higher grade of prostate cancer. The four kallikrein panel of biomarkers utilised 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 and is established as a recommended standard of care in the 2015 NCCN Prostate Cancer Early Detection Guidelines. The 4Kscore test provides individualised risk for the presence of aggressive prostate cancer and adds new information to the shared decision making discussion between the urologist and the patient.