NEW YORK (GenomeWeb) – Accelerate Diagnostics announced today that it has submitted a de novo request for evaluation of Automatic Class III Designation to the US Food and Drug Administration for its Accelerate Pheno system and Accelerate PhenoTest BC kit for positive blood culture samples.
Accelerate Pheno and Accelerate PhenoTest BC use molecular and phenotypic detection technologies to identify pathogens from patient samples, and test them for antimicrobial susceptibility in a high-speed manner, the company said. It creates the potential to expedite optimal antimicrobial therapy for patients suspected of bacteremia or fungemia, which are both life-threatening conditions with high morbidity and mortality risk. The system and kit saved more than 40 hours compared to standard of care methods in recent marketing studies, the firm added.
Accelerate Diagnostics said that it anticipates launching the Accelerate PhenoTest BC kit with 140 individual assays. The final number of assays included in the kit distributed in the US will depend on the review of each individual assay for marketing authorization by the FDA.
The de novo request, sent Friday to the FDA, is supported by a recently completed clinical study including more than 1,800 samples across 13 study sites, the company noted. Overall results across all assays from the study showed 97.4 percent sensitivity and 99.3 percent specificity for pathogen identification results, and 95.1 percent essential agreement and 96.0 percent categorical agreement for antimicrobial susceptibility testing.