Accelerate Achieves CE-IVD Milestone For ID/AST System, Blood Culture Assay

(RTTNews) - Accelerate Diagnostics, Inc. (AXDX) Wednesday announced its declaration of conformity to the European In Vitro Diagnostic Directive 98/79 EC and CE Mark of the Accelerate ID/AST System and ID/AST Blood Culture Assay for in vitro diagnostic use.

The Accelerate ID/AST System is a diagnostic platform, providing rapid identification and antimicrobial susceptibility testing of serious infections.

Additionally, the company initiated enrollment at eight clinical trial sites for its preclinical study. Upon successful completion of these, the FDA registration trial will begin.

Accelerate Diagnostics continues to expect that it will launch an FDA cleared product in the United States in the first half of 2016.