Skip to main content
Premium Trial:

Request an Annual Quote

Accelerate Diagnostics Achieves ISO Certification

NEW YORK (GenomeWeb) – Accelerate Diagnostics today said that it has received ISO 13485:2003 certification. 

The company received certification for its quality management system and has started manufacturing and installing good manufacturing practice-compliant systems at select sites for a clinical trial in preparation of a submission to the US Food and Drug Administration for clearance of the Accelerate ID/AST System. The company also plans to seek FDA clearance for an associated test for positive blood cultures following the successful completion of the trial. 

The platform leverages Accelerate's proprietary technology for single-cell microbiology analysis. It uses a culture-free method for both genomic and phenotypic detection, and the system can perform molecular identification in one hour and provide antibiotic susceptibility testing results in five hours. In January, Accelerate CEO Lawrence Mehren told investors that the firm plans to launch the platform in Europe this year.