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

Driving Malaria-Carrying Mosquitoes Down

Researchers from the UK and Italy have tested a gene drive for mosquitoes to limit the spread of malaria, NPR reports.

Office Space to Lab Space

The New York Times writes that some empty office spaces are transforming into lab spaces.

Prion Pause to Investigate

Science reports that a moratorium on prion research has been imposed at French public research institutions.

Genome Research Papers on Gut Microbe Antibiotic Response, Single-Cell RNA-Seq Clues to Metabolism, More

In Genome Research this week: gut microbial response to antibiotic treatment, approach to gauge metabolic features from single-cell RNA sequencing, and more.