TUCSON, Ariz., June 30, 2015 (GLOBE NEWSWIRE) -- Accelerate Diagnostics, Inc., announced today 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.
This press release contains forward-looking statements within the meaning of the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995, specifically, concerning the company's initiation of the FDA registration trial and the launch of an FDA-cleared product. These statements in this announcement are made based on the company's current beliefs, known events and circumstances at the time of publication and, as such, are subject in the future to unforeseen risks and uncertainties that could cause the company's results of operations, performance and achievements to differ materially from current expectations expressed in, or implied by, these forward-looking statements. These risks include that the results of the pre-clinical study may lead to delays in the initiation of the FDA registration trial or in the launch of an FDA-cleared product. For a full discussion of the company's risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in Item 1A in the company's Annual Report on Form 10-K, filed with the SEC on February 26, 2015. In addition, the company's forward-looking statements could be affected by general industry and market conditions and growth rates. The declaration of conformity to the European In Vitro Diagnostic Directive is not to be construed as guidance regarding the timing or magnitude of European revenues. Except as required by federal securities laws, the company undertakes no obligation to update or revise these forward-looking statements to reflect new events, uncertainties or other contingencies.
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