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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.

The Scan

J&J Booster Support

A US Food and Drug Administration advisory panel has voted to support a booster dose of Johnson & Johnson's SARS-CoV-2 vaccine, according to the Los Angeles Times.

To Keep the Cases Moving

The president of the UK Royal College of Pathologists tells the Financial Times that more investment is needed to tackle a backlog of cases.

NAS Expels Archaeologist

Science reports Luis Jaime Castillo Butters' expulsion is the first of an international member from the US National Academy of Sciences.

PLOS Papers on Angelman Syndrome-Like Cases, Salmonella Paratyphi A, SARS-CoV-2 in Brazil

In PLOS this week: exome sequencing analysis of Angelman syndrome-like cases, genetic epidemiology of Salmonella Paratyphi A, and more.