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Accelerate Dx Q1 Revenues Flat; Plans Clinical Trial for FDA Submission of Microbiology Platform

NEW YORK (GenomeWeb) – Accelerate Diagnostics said in a regulatory document that its revenues for the first quarter were unchanged year over year at $14,000.

All revenues for the three months ended March 31, as well as for the year-ago quarter, were derived from licensing and royalty revenues, the Tucson, Arizona-based firm said in its Form 10-Q filed with the US Securities and Exchange Commission last week. 

The firm, which is developing a platform for single-cell microbiology analysis, said that its net loss for Q1 2015 increased to $8.9 million, or $.20 per share, compared to a net loss of $5.2 million, or $.12 per share, in the year-ago period. 

Its R&D costs grew 78 percent year over year to $6.4 million from $3.6 million, while its SG&A costs increased 45 percent to $2.9 million from $2.0 million. The R&D spending increase resulted from a higher employee headcount, laboratory and instrument and engineering supply purchases, and pre-launch efforts, it said. The SG&A cost growth resulted from salaries and related expenses due to a ramp up in operations, it added. 

During Q1 2015, the firm received a $5 million grant from the National Institutes of Health to develop a test for detecting common bacteria directly from blood. It also achieved ISO 13485:2003 certification, but was hit with a class action lawsuit accusing the company of intentionally misleading investors about the capabilities of its rapid diagnostic platform. 

The platform uses a culture-free method for genomic and phenotypic detection and can perform molecular identification in one hour and provide antibiotic susceptibility testing results in five hours. In its Form 10-Q, Accelerate said that the development of its system is "substantially complete." The firm plans to initiate a clinical trial in the first half of 2015 to support its submission to the US Food and Drug Administration for marketing approval of the platform.