MIAMI, Jan. 09, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced the initiation of a multi-center clinical validation study for the Company's proprietary Total PSA microfluidic assay cassette running on the Claros ® 1 in-office immunoassay analyzer. Over the next several months, the Total PSA clinical study will enroll approximately 1,000 patients at 15 sites across the United States. The clinical study data is expected to support the Premarket Approval (PMA) application to the FDA for the Total PSA assay and the Claros 1 analyzer, as well as pave the way for future FDA submissions of additional assays to be performed on the Claros 1 instrument. "The Claros 1 analyzer delivers highly sensitive, quantitative immunodiagnostic test results with unprecedented convenience for the patient and the medical professional," said David Okrongly, Ph.D., President of OPKO Diagnostics. "The Total PSA assay is the first of a series of immunodiagnostics tests that we believe will make the Claros 1 platform a significant component of 21 st century precision medicine." At the heart of the Claros 1 platform is the patented microfluidics and gold nanoparticle signal amplification technology that combine to deliver accurate, high sensitivity results - from a fingerstick drop of blood - in approximately 10 minutes. "We believe that access to rapid immunodiagnostic test results in the physician's office will be game changing for physicians in allowing them to provide enhanced quality of care for their patients," said Phillip Frost, M.D., OPKO's Chairman and Chief Executive Officer. About OPKO Health, Inc.OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 420-person sales force to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation PDUFA date: January 2017), TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, and TT701, an androgen receptor modulator for androgen deficiency indications. Our biologics business includes hGH-CTP, a once-weekly human growth hormone injection (in phase 3 and partnered with Pfizer), a long-acting Factor VIIa drug for hemophilia (in phase 2a) and a long-acting oxyntomodulin for diabetes and obesity (in phase 1). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information is available at www.opko.com.