Tuesday, June 6, 2023

Accelerate Diagnostics Announces Commercialization of Its Accelerate Arc™ System Having Completed IVDRegistration With FDA

Accelerate Diagnostics, Inc. an in-vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis, today announced commercialization of its new Accelerate Arc Module and BC kit.

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“On the heels of publishing robust data at the 32nd European Congress for Clinical Microbiology and Infectious Diseases demonstrating the value of using the automated Accelerate Arc Module and BC kit, we’re excited to announce this product is now registered as an IVD with the FDA and will soon be available to healthcare facilities in the U.S. market,” said John Meduri, Chief Strategy Officer for Accelerate Diagnostics. “Arc in its early days of commercialization has already generated numerous evaluations and in-bound interest from potential commercial partners. 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.”

Designed for labs with MALDI platforms, the Accelerate Arc Module and BC kit is a novel application of inline centrifugation and automated sample prep techniques, which together with the blood culture (BC) kit, provides a suspension of cleaned microbial cells for direct transfer to a MALDI spotting plate.

The simple load-and-go workflow eliminates the need for batching multiple specimen tests, cutting hours off the wait for microbial ID results for positive blood cultures. The Accelerate Arc Module requires just 2-3 minutes of hands-on time to run and is simple enough to be used on all shifts, by any laboratory technician, freeing up valuable technician time by automating the MALDI workflow. Further, this automated, rapid workflow that the Accelerate Arc system avails is the perfect companion to the Accelerate PhenoTest® BC kit AST configuration enabling laboratories to report identification and antimicrobial susceptibility test results directly from positive blood cultures days earlier than current standard-of-care methods.

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