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

Published: Wednesday, January 11, 2012
Last Updated: Wednesday, January 11, 2012
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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.

The clinical trial is designed for both 510(k) clearance and potential CLIA-waiver of the test. Up to 5 study sites across the United States are participating and we expect to enroll a total of approximately 400 patients. The study will test PSA levels over a 6-month period and is intended to demonstrate equivalence with results obtained with larger laboratory instrumentation. Equivalence necessary to obtain the CE mark has already been confirmed.

“I am pleased to announce the launch of this trial as we continue with our plans to build out a larger panel of urologic tests,” said Phillip Frost, M.D., Chairman and CEO of OPKO Health, Inc.


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