Opko Health, a multinational biopharmaceutical and diagnostics company, has launched the 4Kscore test, the only blood test that accurately identifies risk for aggressive prostate cancer, in Mexico through its wholly owned subsidiary, Opko Health Mexico. The launch in Mexico follows the US and European launch of the 4Kscore test in 2014.
The 4Kscore provides a patient with his own individualised risk for aggressive prostate cancer. The test was developed and validated by Opko in a 1,012 patient blinded, prospective study in the United States in 2014. The results of this validation trial were published in the journal European Urology and presented at the 2014 Congress of the Mexican Society of Urology by one of the publication's authors, Dr. Sanoj Punnen, of the University of Miami.
"We are pleased to now be able to offer the 4Kscore test to the clinicians and patients of Mexico," said Joaquin Peniche, chief executive officer, of Opko Health Mexico. "The plenary presentation on the 4Kscore was well received by Urologists attending the Congress of the Mexican Society of Urology in Guadalajara, Mexico this past November and we now look forward to offering the product into the Mexican market."
In Mexico, prostate cancer is the most common cause of cancer death in males with 5,911 deaths recorded in 2012.
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 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.