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BRIEF-OPKO Health submits premarket approval application with FDA for PSA test
2017年11月7日 / 下午1点39分 / 12 天前

BRIEF-OPKO Health submits premarket approval application with FDA for PSA test

Nov 7 (Reuters) - OPKO Health Inc

* OPKO Health submits premarket approval application with FDA for a point-of-care PSA test with the Claros 1 platform

* OPKO Health Inc - ‍filing contains clinical data from company’s 864-patient total psa clinical study​

* OPKO Health Inc - ‍OPKO expects to initiate clinical validation studies and to file a 510(k) application for a Claros 1 testosterone test in 2018​

* OPKO Health - working to add additional tests for vitamin D, infectious diseases, cardiology, women’s health, companion diagnostics to Claros 1 menu​ Source text for Eikon: Further company coverage:

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