Accelerate Diagnostics, Inc. announced the release and CE marking of its latest Accelerate PhenoTest™ BC kit, declaring conformity to the European Directive 98/79/EC on in vitro diagnostic medical devices.
The new CE-IVD Accelerate PhenoTest™ BC kit now includes phenotypic antimicrobial susceptibility test (AST) results for ceftazidime-avibactam and ceftolozane-tazobactam for Enterobacteriaceae and P. aeruginosa bacteria, and trimethoprim-sulfamethoxazole for A. baumannii bacteria.
In addition, the new BC kit contains updates to clinical interpretive breakpoints bringing 144 organism and antimicrobial combinations current to 2019 EUCAST (European Committee on Antimicrobial Susceptibility Testing) guidance. AST results are available in approximately 7 hours, with organism identification results available approximately 5 hours prior.
“We continue to hear from clinicians that there are fewer treatment options for patients with bloodstream infections,” said Chad Brueck, head of global marketing for Accelerate Diagnostics. “As antimicrobial resistance continues to rise, it is critical that the tools used by the laboratory continue to adapt to provide clinically actionable, phenotypic susceptibility results to expand treatment options for these patients.”
The new CE-IVD Accelerate PhenoTest™ BC kit (catalog: 10102028) is available to hospitals and health systems within the European Economic Area and other regions that recognize the European Directive.
The US-IVD Accelerate PhenoTest™ BC kit (catalog: 10101018) received clearance for in vitro diagnostic use in February of 2017.
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. The Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit combine several technologies aimed at reducing the time clinicians must wait to determine the most optimal antibiotic therapy for deadly infections.
The system and kit fully automate the sample preparation steps to report phenotypic antibiotic susceptibility results in approximately 7 hours direct from positive blood cultures. Recent external studies indicate the solution offers results 1-2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage specific to the individual patient days earlier.
The “ACCELERATE DIAGNOSTICS” and “ACCELERATE PHENO” and “ACCELERATE PHENOTEST” and diamond shaped logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc.
For more information about the company, its products and technology, or publications, visit axdx.com.