PARIS - Biomérieux, a French healthcare company specializing in diagnostics, said on Monday it had won more positive feedback from the US Food and Drug Administration (FDA) regulator for its product aimed at helping test for the coronavirus.
BioMerieux said its 'BIOFIRE® RP2.1' panel testing product, which includes 22 pathogens that cause respiratory infections including SARS-CoV-2 which causes the COVID-19 coronavirus, had won 'emergency use authorization' from the FDA.
While the 'BIOFIRE® RP2.1' test has not had full clearance or approval from the FDA, the decision to give the product 'emergency use authorization' nevertheless marks more progress.
BioMérieux said it was looking to scale up supply of the BIOFIRE® RP2.1 panel at its production facilities in Salt Lake City (Utah, USA).
Test kits will be available for commercial distribution in the USA under the emergency use authorization, as well as internationally where regulatory approval allows.
BioMérieux added it expected to steadily build inventory levels to address the needs of the thousands of labs and healthcare professionals given an expected rise in demand for products aimed at testing for the presence of the coronavirus.
-reuters-
