Skip to main content
Premium Trial:

Request an Annual Quote

Accelerate Dx Lands CE Mark for ID/AST System, Initiates Clinical Trial Enrollment

NEW YORK (GenomeWeb) – Accelerate Diagnostics today announced it has received the CE-IVD mark for its Accelerate ID/AST System and ID/AST Blood Culture Assay and has begun enrolling trial sites for a preclinical study.

The Accelerate platform uses proprietary single-cell microbiology analysis technology to rapidly identify pathogens and provide information on their antibiotic susceptibility for clinical diagnosis.

The firm said in a statement that it has also initiated enrollment for its clinical trial for the platform in preparation for a 510(k) submission to the US Food and Drug Administration at eight trial sites. The firm maintained its expectation that it will launch an FDA-cleared product in the United States in the first half of 2016.

Accelerate Diagnostics CEO Lawrence Mehren said in January at the JP Morgan Healthcare Conference that the firm planned to launch the platform in Europe this year and would begin clinical trials in preparation for the 510(k) submission.

In March, Tucson, Arizona-based Accelerate received ISO 13485:2003 certification for its quality management system.

The Scan

Support for Moderna Booster

An FDA advisory committee supports authorizing a booster for Moderna's SARS-CoV-2 vaccine, CNN reports.

Testing at UK Lab Suspended

SARS-CoV-2 testing at a UK lab has been suspended following a number of false negative results.

J&J CSO to Step Down

The Wall Street Journal reports that Paul Stoffels will be stepping down as chief scientific officer at Johnson & Johnson by the end of the year.

Science Papers Present Proteo-Genomic Map of Human Health, Brain Tumor Target, Tool to Infer CNVs

In Science this week: gene-protein-disease map, epigenomic and transcriptomic approach highlights potential therapeutic target for gliomas, and more