May 4, 2020 / 5:07 AM / a month ago

BRIEF-Biomerieux: BIOFIRE® Respiratory Panel 2.1 (RP2.1) with SARS-CoV-2 Obtains FDA Emergency Use Authorization

May 4 (Reuters) - Biomerieux SA:

* BIOMÉRIEUX: BIOFIRE® RESPIRATORY PANEL 2.1 (RP2.1) WITH SARS-COV-2 OBTAINS FDA EMERGENCY USE AUTHORIZATION

* BIOMÉRIEUX: BIOFIRE® RESPIRATORY PANEL 2.1 (RP2.1) WITH SARS-COV-2 OBTAINS FDA EMERGENCY USE AUTHORIZATION

* BIOMÉRIEUX IS CURRENTLY MAKING EVERY EFFORT TO SCALE UP SUPPLY OF BIOFIRE(®) RP2.1 PANEL AT ITS PRODUCTION FACILITIES IN SALT LAKE CITY

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

* bioMérieux plans to submit the BIOFIRE(®) RP2.1 panel for FDA de novo clearance.

* Outside of the USA, bioMérieux is simultaneously pursuing CE Mark certification for the BIOFIRE(®) Respiratory 2.1plus (RP2.1plus) panel, which also includes detection of MERS-CoV, on an accelerated timeline. Source text for Eikon: Further company coverage: (Reporting by Sudip Kar-Gupta)

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