BRANFORD, CONN. (PRWEB) DECEMBER 19, 2017
The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), has awarded GeneSpark Diagnostics a contract to develop a field-deployable Anthrax diagnostic assay.
This contract will advance and expand the ability to combat the threat of Bacillus anthracis by utilizing the GeneSparkDxTM Molecular Diagnostic System, which is a rapid, sensitive, low cost, and fully portable molecular diagnostic platform. The high sensitivity, portability, and speed provided by the GeneSpark platform will allow for earlier and more accurate diagnosis of this deadly infection, allowing for more effective treatment and improved tracking of outbreaks.
The contract with BARDA will fund the development and commercialization of the GeneSparkDxTM instrument platform, along with the GeneSpark assay disk, and GeneSpark's proprietary rapid sample processing technology. In addition, under this contract GeneSpark will be developing assays to rapidly detect genomic markers of antibiotic resistance for a range of other bacterial threats.
This is a 3-phase, 3.5-year project, which is expected to result in an FDA 510(k) submission for clearance of the Anthrax assay. Phase one of the contract, which commenced in October 2017, is valued at $3.2MM, followed by two optional phases valued at an additional $6.2MM.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201700028C.
About GeneSpark Diagnostics:
GeneSpark Diagnostics is a pilot stage diagnostic instrument company that has developed a group of novel technologies that have been incorporated into a rapid (<1hr), mobile (<1 Kg), easy-to-use, and extremely sensitive molecular diagnostic platform. The performance parameters of the GeneSparkDxTM system sets it apart from competitors, and will allow it to rapidly diagnose a variety of sepsis causing pathogens directly from whole blood. In addition, the GeneSparkDxTM platform can simultaneously perform up to 33 different assays on a single patient sample, enabling cost effective syndrome-based diagnostic panels.