TUCSON, Ariz., Aug. 2, 2019 /PRNewswire/ -- 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.
Certain of the statements made in this press release are forward looking, such as those, among others, about the company's projections as to when certain key business milestones may be achieved, the potential of the company's products or technology, the growth of the market, the company's estimates as to the size of its market opportunity and potential pricing, the company's competitive position and estimates of time reduction to results, and its future development plans and growth strategy. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Information about the risks and uncertainties faced by Accelerate Diagnostics is contained in the section captioned "Risk Factors" in the company's most recent Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 1, 2019, and in any other reports that the company files with the Securities and Exchange Commission. The company's forward-looking statements could be affected by general industry and market conditions. Except as required by federal securities laws, the company undertakes no obligation to update or revise these forward-looking statements to reflect new events, uncertainties or other contingencies.
SOURCE Accelerate Diagnostics, Inc.