OPKO Health (OPK) Misses Q3 EPS by 3c, Miss on Revenues
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OPKO Health (OPK) Submitted PMA Application with FDA for Point-of-Care PSA Test with Claros 1 Platform
November 7, 2017 8:17 AM ESTOPKO Health, Inc. (NASDAQ: OPK) announces the filing of a Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for the Total PSA test with the Claros® 1 immunoassay analyzer. The filing contains clinical data from the Companys 864-patient Total PSA clinical study.
The Claros 1 immunoassay analyzer is a novel diagnostic instrument system that can provide rapid, quantitative blood test results in 10 minutes right in the physicians office. The Claros 1 incorporates cutting edge microfluidics in a credit card sized disposable test... More
