MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NYSE:OPK) today announced the launch of 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 U.S. and European launch of the 4Kscore test in 2014.
The 4Kscore provides a patient with his own individualized 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, CEO 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.
About Prostate Cancer
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 U.S. 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.
About the 4Kscore Test
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.
About OPKO Health
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.opko.com.
SAFE HARBOR STATEMENT
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected benefits of the 4Kscore Test, that the 4Kscore will accurately identify risk for aggressive prostate cancer, whether the test will bring value to Mexican healthcare by allowing clinicians to accurately identify risk for aggressive prostate cancer, whether the test will benefit patients and the healthcare system by helping avoid the cost of unnecessary, sometimes harmful procedures, whether the 4KscoreTest can help target the right patients for aggressive treatment and avoid the harms that accompany over detection and over treatment of indolent prostate cancer, expected growth in use of the test in the U.S., Mexico and Europe and whether the test will accurately predict high-grade cancers, whether OPKO will successfully commercialize the 4Kscore, the market for and expected sales of 4Kscore, whether the test will be an important benefit for Urologists and their patients and will lead to lower overall healthcare costs, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.