OPKO Health, Inc. Announces Initiation of Claros 1 Clinical Trial for Total PSA
January 09, 2017 at 01:31 pm
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OPKO Health, Inc. 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. 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.
OPKO Health, Inc. is a multinational biopharmaceutical and diagnostics company. The Company's diagnostics segment consists of the clinical laboratory operations of BioReference Health, LLC (BioReference), its point-of-care operations. Its pharmaceutical segment consists of the pharmaceutical operations in Chile, Mexico, Ireland, Israel, Spain, Ecuador, France, the United States, and its pharmaceutical research and development operations. Through BioReference, it operates specialized laboratory divisions, such as GenPath (Urology), GenPath (Oncology), and GenPath (Women's Health). It has two commercial stage pharmaceutical products and several pharmaceutical compounds and technologies in various stages of research and development for a range of indications and conditions, including Rayaldee, Rayaldee, Oxyntomodulin, Biologics, NGENLA Somatrogon, and Factor VIIa-CTP. It develops and manufactures specialty active pharmaceutical ingredients (APIs) through FineTech Pharmaceutical, Ltd.
OPKO HEALTH, INC. 
