Close Menu

antibiotic resistance

The test will leverage next-generation sequencing to sequence PCR amplicons of the UL54 and UL97 genes in which drug resistance with CMV has been associated.

In an SEC document, the company said net proceeds are expected to be $5.8 million and will be used to support an anticipated submission to the FDA, among other things.

The firm said that the panel is expected to receive CE marking for commercial availability in Europe later this year.

The company has been gearing up to submit its Acuitas AMR Gene Panel product to the US Food and Drug Administration for regulatory clearance.

The organizations said that FIND's expertise will help CARB-X ensure diagnostic investments have the maximum impact against antimicrobial resistance.

The company has adopted a reagent rental approach which it believes supported the placement of 133 instruments in the quarter.

The firm published a study showing the technology could be used to determine antimicrobial susceptibility as well as minimum inhibitory concentrations.

The BioFire FilmArray Pneumonia panel will be used to optimize clinical trial enrollment for an antibiotic to treat combat carbapenem-resistant A. baumannii infections.

The firm hopes to seek 510(k) clearance from the US Food and Drug Administration for its combined identification and antimicrobial sensitivity test by the end of 2019.

New funding will support assay development and lab space to offer test services, and ultimately a test kit using the firm's resistance database.

Pages