March 24, 2020 / 6:58 AM / 11 days ago

BRIEF-Biomerieux Gets U.S. Approval For Biofire Covid-19 Test

March 24 (Reuters) - BIOMERIEUX SA:

* BIOMERIEUX RECEIVES EMERGENCY USE AUTHORIZATION FOR BIOFIRE® COVID-19 TEST

* SUBSIDIARY, BIOFIRE DEFENSE, HAS RECEIVED EMERGENCY USE AUTHORIZATION BY U.S. FOOD AND DRUG ADMINISTRATION OF ITS BIOFIRE(®) COVID-19 TEST FOR USE IN CLIA MODERATE AND HIGH COMPLEXITY CLINICAL LABORATORIES TO DETECT SARS-COV-2

* THIS IS SECOND OF THREE TESTS BEING DEVELOPED FOR DIAGNOSTIC USE AS PART OF BIOMERIEUX’S STRATEGIC RESPONSE TO COVID-19 PANDEMIC

* MAKING EVERY EFFORT TO SCALE UP SUPPLY OF BIOFIRE(® )COVID-19 TEST AT MULTIPLE PRODUCTION FACILITIES IN SALT LAKE CITY (UTAH, USA)

* TEST KITS WILL BE AVAILABLE FOR COMMERCIAL DISTRIBUTION IN UNITED STATES UNDER EUA AS WELL AS INTERNATIONALLY WHERE REGULATORY APPROVAL ALLOWS

* HAS ALSO RECEIVED AUTHORIZATION TO SELL BIOFIRE(®) COVID-19 TEST EXTERNAL CONTROL KIT

* IS NOW LAUNCHING A SECOND DIAGNOSTIC TEST FOR DETECTION OF SARS-COV2

* BIOMERIEUX EXPECTS TO HAVE MAXIMUM PRODUCTION CAPABILITY WITHIN A FEW WEEKS

* THIS POSITIVE CONTROL MATERIAL MAY BE USED FOR QUALITY CONTROL AND LABORATORY VERIFICATION OF TEST Source text for Eikon: Further company coverage: (Gdansk Newsroom)

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