BioMérieux: FDA waiver for new test

(CercleFinance.com) - bioMérieux announced on Wednesday that it had obtained special clearance and a CLIA waiver from the US FDA for its latest test to detect the most common respiratory viruses, including influenza, and strep throat.


The 'Biofire Spotfire R/ST Panel Mini' system is capable of identifying five of the most common viruses and bacteria responsible for respiratory infections or sore throats in around 15 minutes.

The in vitro diagnostics specialist explains that obtaining a CLIA (Clinical Laboratory Improvement Amendments) waiver enables use by non-laboratory professionals.

These products can be used directly in places where patients are cared for, such as urgent care centers, doctors' surgeries or pharmacies.

Samples are taken by nasopharyngeal swab when a respiratory tract infection is suspected, or by oro-pharyngeal swab when pharyngitis is suspected.

The new test will be available from the third quarter of 2024 in the US.


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