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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.

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