BioMérieux Joint Infection Panel Gets FDA De Novo Authorization

Original from: Genomeweb

BioMérieux said on Wednesday that its BioFire Joint Infection (JI) Panel has received de novo authorization from the US Food and Drug Administration. 

The 39-target panel tests for 31 pathogens implicated in most acute joint infections as well as eight antimicrobial resistance genes to help improve antibiotic therapy and stewardship. It uses synovial fluid samples obtained from the affected joint and runs on the FDA-cleared and CE-marked BioFire FilmArray 2.0 and BioFire Torch systems. 

BioMérieux said the panel requires two minutes of sample preparation time, yielding results in about an hour. 

The company submitted the panel for FDA clearance in late 2020.

"The BioFire Joint Infection Panel should provide clinicians with a faster and more accurate diagnosis, thus potentially reducing the delay to initiate appropriate antimicrobial therapy, speeding up surgical decision-making, and improving overall management to benefit patients and improve outcomes," BioMérieux Chief Medical Officer Mark Miller said in a statement. 

The company said it is targeting a commercial launch in the US within the next two months and will gradually register and market the test in other countries, including those recognizing FDA clearance. BioMérieux said it will also submit the panel for CE marking in the coming weeks. 

The new test joins five other so-called “syndromic panels” available on BioFire’s testing platforms, including for respiratory infections (high-plex and mid-plex), pneumonia, blood culture identification, gastrointestinal infections, and meningitis/encephalitis. The commercial availability and regulatory status of these panels vary by country. 

BioMérieux said that as of March 31, more than 22,500 FilmArray systems have been installed globally. 

Source:  BioMérieux Joint Infection Panel Gets FDA De Novo Authorization