Accelerate Submits De Novo Request to FDA for Testing Kits

Accelerate Diagnostics, Inc. announced the submission of a De Novo request for Evaluation of Automatic Class III Designation to the U.S. Food and Drug Administration (FDA) for its Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for positive blood culture samples.  

The fully automated system provides high-speed identification (ID) and antimicrobial susceptibility testing (AST) of pathogens from patient samples faster than conventional methods. In recently completed marketing studies, the system and kit saved more than 40 hours as compared to standard of care methods; creating the potential to expedite optimal antimicrobial therapy for patients suspected of bacteremia or fungemia, both life-threatening conditions with high morbidity and mortality risk.

The Accelerate PhenoTest™ BC kit consists of a highly multiplexed panel of assays targeting the most prevalent microorganisms and the antimicrobial agents typically used to treat them.  Accelerate anticipates launching the BC kit with 140 individual assays. The final number of assays included in the kit distributed in the U.S. will depend on the review of each individual assay for marketing authorization by the FDA.

The De Novo request, sent Friday evening to the FDA, is supported by a recently completed clinical study including more than 1,800 samples across 13 study sites. Overall results across all assays from the study showed 97.4% sensitivity and 99.3% specificity for ID results and 95.1% essential agreement and 96.0% categorical agreement for AST.