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Accelerate Diagnostics Registers Microbial ID Sample Prep, Blood Culture Kit With FDA

NEW YORK ─ Accelerate Diagnostics on Monday announced the in vitro diagnostic registration of its Accelerate Arc Module and BC kit with the US Food and Drug Administration to enable the automated, rapid microbial identification of positive blood cultures across the installed base of MALDI mass spec systems. 

The Tucson, Arizona-based firm added that on the back of the FDA registration it is commercializing the Accelerate Arc system comprising the Arc Module and BC kit.

"Arc in its early days of commercialization has already generated numerous evaluations and in-bound interest from potential commercial partners," John Meduri, chief strategy officer for Accelerate Diagnostics, said in a statement. "Using our system, the total cost to rapidly identify organisms from positive blood cultures is significantly less than what laboratories are paying today for a rapid molecular ID solution."

The Accelerate Arc Module and BC kit applies inline centrifugation and automated sample prep techniques, which together with the BC, blood culture, kit, provides a suspension of cleaned microbial cells for direct transfer to a MALDI spotting plate, Accelerate said.

The load-and-go workflow eliminates the need to batch multiple specimen tests, cutting hours off the wait for microbial ID results for positive blood cultures, the firm said, adding that the Accelerate Arc Module enables two to three minutes of hands-on time and can be used during all shifts by laboratory technicians, freeing up time by automating the MALDI workflow.

Accelerate said that the Arc automated, rapid workflow can also be used with its PhenoTest BC kit antimicrobial susceptibility test (AST) configuration, enabling laboratories to report identification and AST results directly from positive blood cultures days earlier than current standard-of-care methods.