BRANFORD, Conn.--(BUSINESS WIRE)--The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) awarded GeneSpark Diagnostics, Inc. the second phase of a contract to develop a field-deployable Anthrax diagnostic assay and expand the research to an antimicrobial resistance diagnostic assay.
The BARDA contract with GeneSpark Diagnostics is, potentially, a 3.5-year project, which is expected to advance and expand the ability to combat the threat of Bacillus anthracis by utilizing the GeneSparkDxTM Molecular Diagnostic System. GeneSparkDx will provide a rapid, highly sensitive, low cost, and fully portable molecular diagnostic platform. The high sensitivity, portability, and speed provided by the GeneSpark platform is expected to facilitate a more accurate diagnosis of Anthrax, allowing for more effective treatment and improved response to outbreaks. The contract with BARDA will fund the development of the GeneSparkDx instrument platform, with the anticipation of an FDA 510(k) clearance of the Anthrax molecular diagnostic assay and the development of additional tests to detect antimicrobial resistance markers directly from blood.
The first phase of the contract commenced in October 2017 and was valued at $3.2 million. GeneSpark completed the first phase in February 2019 and delivered a functional GeneSparkDx Instrument with a sensitive Anthrax test. Independent testing by Battelle demonstrated the GeneSparkDx test can detect Anthrax virulence genetic markers with sensitivity as low as, approximately, 5 CFU/ml from 3 ml whole blood samples.
The newly funded second phase of the contract, which started in July 2019, is for $3.8 million. It includes the development of a blood test for a panel of multiple drug resistance markers directly from blood for up to potentially 32 resistance markers or organisms. Dr. John Davidson, Chief Scientific Officer of GeneSpark stated “The ability to rapidly identify antimicrobial resistance without first culturing blood is a needed tool in the fight against rising antibiotic resistant infectious microbes.”
The project has been funded 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, Inc. was founded in 2013 and is located in Branford, Connecticut. The company developed the GeneSparkDx platform for fast and accurate detection of targeted DNAs and RNAs directly from specimens by using rapid isothermal nucleic acid detection. Use of GeneSpark's system, which does not require laboratory facilities, delivers faster, simpler, more sensitive detection at a lower cost than other commercial technologies. The GeneSparkDx platform is on track for infectious disease clinical studies. To learn more, please visit: http://tangenbio.com/
Forward-Looking Statements:
This press release contains “forward-looking statements” concerning the development and future commercialization of the company’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. GeneSpark Diagnostics undertakes no obligation to update any forward-looking statements.