Accelerate Diagnostics Achieves CE-IVD Milestone for ID/AST System and ID/AST Blood Culture Assay
Accelerate Diagnostics, Inc., announced on June 30,2015 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.
In addition, the company initiated enrollment at 8 clinical trial sites for its preclinical study. Upon successful completion the FDA registration trial will begin. Given the aforementioned progress, the company maintains its expectation that it will launch an FDA cleared product in the United States in the first half of 2016.
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. (Nasdaq:AXDX), is an in vitro diagnostics company dedicated to providing solutions for the global challenge of antibiotic resistant organisms. The company’s revolutionary ID/AST platform utilizes a proprietary process with both genomic and phenotypic detection technologies that significantly decrease the time to result while achieving high sensitivity and specificity. For more information about the company and products visit www.acceleratediagnostics.com.
Source: Accelerate Diagnostics, Inc.