OPKO Health, Inc., a multinational biopharmaceutical and diagnostics company,  has announced the European launch of the 4Kscore Test, the only blood test that accurately identifies risk for aggressive prostate cancer, through its wholly owned subsidiary, OPKO Health Spain. The launch in Europe follows the US launch of the 4Kscore earlier this year.

The 4Kscore is a blood test that provides a patient his individualized risk for aggressive prostate cancer. The panel of biomarkers utilized in the 4Kscore is based on over a decade of clinical research conducted in Europe by investigators from Memorial Sloan-Kettering Cancer Center and leading European medical institutions involving over 10,000 patients. The 4Kscore Test was developed and validated by OPKO Lab in a 1,012 patient blinded, prospective study in the US in 2014. "We are proud to now offer the 4Kscore Test to European clinicians and patients," said Julián Agut Sánchez, CEO of OPKO Health Europe. "The 4Kscore will bring exceptional value to European healthcare by allowing clinicians to accurately identify risk for aggressive prostate cancer. In addition, there is great benefit for the patients and the healthcare systems in avoiding the cost of unnecessary, sometimes harmful procedures."

The European launch of the 4Kscore Test is being done in partnership with Barnaclínic, a branch of Hospital Clínic de Barcelona, one of the most modern and largest clinical laboratories in Europe. "The 4Kscore Test represents the new direction we must follow in clinical medicine by combining multiple biomarkers for greater diagnostic accuracy and delivering the results to the clinician in an easy to interpret report," said Aurea Mira Vallet, manager of the Diagnostic Biomedical Center, Hospital Clínic de Barcelona. "We look forward to our partnership with OPKO on the 4Kscore Test and helping European Urologists to more accurately identify risk for aggressive prostate cancer."

Prostate cancer is the most common cancer in Europe for males with over 400,000 new cases diagnosed in 2012. However, most of these cancers are indolent cancers and are not likely to be life threatening to the patient. "By accurately identifying risk for the aggressive form of prostate cancer, the 4Kscore Test can make a significant contribution in Europe to help target the right patients for aggressive treatment and avoid the harms that accompany over detection and over treatment of indolent prostate cancer," said David Okrongly, president of OPKO Diagnostics. "We look forward to the growth in use of the 4Kscore in the US and Europe, and plan to launch the test in Latin America in the coming months."

According to the World Health Organization, prostate cancer is the second most common cancer in men worldwide, with over 1.1 million men diagnosed with prostate cancer in 2012 and over 300,000 men dying from their disease. In countries like the US where screening for prostate cancer with the PSA test began 20 years ago, there has been a sharp decline in prostate cancer mortality and sharp rise in the incidence of prostate cancers detected. However, most of the prostate cancers that are now detected are an indolent, non-life threatening form of the disease. The net result has been over detection and over treatment of indolent prostate cancers and a rise in the complications from prostate cancer treatment such as infection, erectile dysfunction, urinary obstruction and incontinence.

The 4Kscore is the only 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.