Market Overview

OPKO Health Announces Commencement of U.S. Clinical Trial for Point-of-Care Prostate Specific Antigen Test

OPKO Health, Inc. (NYSE: OPK) today announced the commencement of a multi-center clinical study of OPKO's point-of-care diagnostic test for prostate specific antigen (PSA) utilizing its proprietary diagnostic platform. OPKO intends to submit its application to the U.S. Food and Drug Administration for approval of the assay in 2012.

The PSA test on OPKO's platform requires only a finger stick drop of blood and utilizes a novel microfluidics system consisting of a credit card size disposable test cassette and a small but sophisticated desktop analyzer to provide physicians and patients with accurate, lab quality results within minutes. OPKO has already obtained a CE mark for this PSA test in Europe and other markets outside the United States.

Posted-In: News FDA

 

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