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PRESS RELEASE: Accelerate Diagnostics Seeks FDA 510(k) Clearance for Expanded Abx Susceptibility Tests

Image created by Dr. Michael J. Miller

Accelerate Diagnostics has filed a 510(k) premarket submission for a gram-negative menu expansion and breakpoint updates for its Accelerate PhenoTest BC kit used for antimicrobial susceptibility testing.

A previous version of the test and the Accelerate Pheno system received US Food and Drug Administration clearance in 2017 for rapid pathogen identification and phenotypic antibiotic susceptibility testing. In 2021, the firm began selling a new configuration of the kit in the US and secured CE marking for that configuration. The Tucson, Arizona-based firm said its recent 510(k) submission includes escalation and de-escalation agents for gram-negative organisms, additional antibiotics for treatment of Acinetobacter baumannii infection, and breakpoint updates for existing susceptibility measures. It also includes oral antibiotic options for de-escalation, which can aid patient discharge planning.

The Accelerate Pheno system and BC kit provide fully automated sample preparation and results in about seven hours direct from positive blood cultures.

Accelerate CEO Jack Phillips said in a statement that the updated PhenoTest panel "adds meaningful new antibiotic choices for clinicians to minimize time to optimal therapy for patients with bloodstream infections."

"These additions and improvements will increase the value of the Pheno system in hospitals across the country, enhancing the clinical value labs have been experiencing for the past several years," he said.

The firm said in May it plans to launch and commercialize a new system for MALDI mass spectrometry and update its Pheno platform, with clinical trials of the Pheno II instrument planned for 2023. It also entered into a commercial agreement this August with Becton Dickinson, which will sell the Accelerate Pheno system and Accelerate Arc module for antimicrobial susceptibility testing.

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