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Accelerate Diagnostics Gets CE Mark on Updated and Expanded PhenoTest BC kit

NEW YORK – Accelerate Diagnostics today announced that a version of its PhenoTest BC kit including additional antimicrobial susceptibility testing has received CE-IVD marking and is now available to hospitals and health systems in regions that recognize the CE mark.

The expanded kit includes phenotypic antimicrobial susceptibility test results for the antimicrobials ceftazidime-avibactam and ceftolozane-tazobactam for Enterobacteriaceae and P. aeruginosa bacteria, and trimethoprim-sulfamethoxazole for A. baumannii bacteria.

The new kit also includes updates to clinical interpretive breakpoints, bringing 144 organism and antimicrobial combinations current to 2019 European Committee on Antimicrobial Susceptibility Testing guidance, the Tucson, Arizona-based diagnostics maker noted in a statement.

The system and kit fully automate the sample preparation steps to report phenotypic antibiotic susceptibility results in approximately seven hours direct from positive blood cultures, with organism identification results available approximately five hours prior. The original PhenoTest BC kit was cleared by the US Food and Drug Administration in 2017.