Accelerate Diagnostics

The firm will encounter stiff competition, particularly from BioMérieux and Luminex, but there are untapped opportunities for adoption, according to industry analysts.

The test is based on a biomarker signature that consists of a core set of 31 genes associated with endotoxin tolerance in sepsis patients.

Despite the array of tests available, some lab directors are still seeking broader functionalities and capabilities from the systems they purchase.  

The company's test kit can ID pathogenic organisms and provide a measure of antibiotic susceptibility directly from positive blood culture samples.

The company's test kit provides identification and antimicrobial susceptibility testing of pathogens for patients suspected of bacteremia or fungemia.

The US District Court for the District of Arizona has granted Accelerate Dx's motion to dismiss a class-action lawsuit filed against it last year.

The firm's revenues nominally increased due to licensing agreements, while expenses also increased as the company ramps up its R&D efforts.

The regulatory activity for the diagnostic platform follows ISO 13485:2003 certification in March. The firm is also planning a 510(k) submission to the FDA.

The company's net loss grew on higher expenses, while it said in its Form 10-Q that it plans to initiate a clinical trial for its microbiology diagnostic platform in H1 2015.

The suit alleges that the firm's "culture-free" rapid pathogen detection platform actually requires a positive blood culture.

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