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FDA Clears Enhancements to Accelerate Diagnostics Pheno System

NEW YORK – Accelerate Diagnostics said on Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for enhancements to the Accelerate Pheno system.

The additions improve the system's performance and expand its antimicrobial susceptibility testing menu for bloodstream infections. Specifically, the new products improve susceptibility testing performance for four antibiotics used to treat Pseudomonas aeruginosa and add the combination of P. aeruginosa and aztreonam to the Accelerate PhenoTest BC kit testing panel.

"These improvements to our PhenoTest BC kit will provide clinicians with an even wider array of results to inform highly tailored treatment options for patients with bacteremia and sepsis," Accelerate CSO Shelley Campeau said in a statement. "We believe that these new tests will support improved patient outcomes and further strengthen the trust that laboratories place in our system."