BRANFORD, Conn.--(BUSINESS WIRE)--GeneSpark Diagnostics, Inc. announced today that it was awarded a contract by the New York State Department of Health’s Wadsworth Center in conjunction with Health Research Inc. to develop a point-of-care device for detection of Candida auris, a “superbug” that is resistant to anti-fungal drugs and is emerging as a public health threat. According to the CDC, New York State has the most Candida auris cases in the United States. GeneSparkTM was selected as one of the three awardees for this contract to join forces with the Wadsworth Center to fight against this drug resistant fungus. GeneSpark will independently develop a skin-swab based Candida auris assay running on its portable GeneSparkTM instrument and will also develop a swab-based Candida auris test for environmental surveillance.
GeneSpark has developed a molecular diagnostic platform called GeneSparkDxTM – a small footprint, rapid, highly sensitive, and low-cost system. GeneSparkDx is composed of an assay kit and a GeneSpark analyzer. The GeneSparkDx has been developed for rapid diagnosis of bloodstream candida infections, bacterial infections including Bacillus anthracis, and an antimicrobial-resistant panel directly from whole blood in less than one hour. During the COVID-19 pandemic, GeneSpark has focused on developing a point-of-care SARS-CoV-2 assay and intends to submit an Emergency Use Authorization notification to FDA within the next month. GeneSpark's new contract with Wadsworth Center is expected to further expand GeneSpark's product pipeline to include a clinical as well as an environmental Candida auris test. The high sensitivity, portability, and speed provided by the GeneSparkDx platform is expected to facilitate a faster and more accurate diagnosis of Candida auris, allowing for an improved response to outbreaks of this threat.
The current GeneSpark bloodstream candida panel used on the GeneSparkDx can detect fewer than 5 CFU/ml of the five most prevalent Candidiasis species in less than one hour from a whole blood sample without culture. “We are building upon the foundation of GeneSpark's existing Candida Bloodstream Infection diagnostic assay, and predict we can rapidly develop a Candida auris test for both blood and skin swab samples with very low risk and achieve high sensitivity and specificity,” Dr. John Davidson, Chief Scientific Officer of GeneSpark and the Principle Investigator of this contract, stated. “Rapidly detecting Candida auris is crucial to control its spread in hospitals and the community, including nursing homes, which have been identified as incubators for this superbug. We are excited to work with the Wadsworth Center to address this very important public health issue."
“New York State’s continued support continues to advance the nation’s efforts to control this fungus that predominantly affects an already vulnerable population, including those in nursing homes and people with compromised immune systems,” said Jill Taylor, Ph.D., Director of the Wadsworth Center. “We look forward to working with GeneSpark to bring this important tool to frontline health care settings.”
About GeneSpark Diagnostics, Inc.:
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 rotary rapid isothermal nucleic acid detection. The GeneSpark system consists of the GeneSparkDx™ disc and the GeneSpark™ instrument, an automated amplification device. The GeneSparkDx™ platform, which does not require laboratory facilities, is expected to deliver faster, simpler, more sensitive detection at a lower cost than other commercial technologies. Current tests in development include COVID-19, Candida auris, sepsis causing bacteria, antibiotic resistance genes, and a Candida blood panel. The GeneSparkDx platform is on track for infectious disease clinical studies. To learn more, please visit: https://tangenbioscience.com/
About Wadsworth Center:
The Wadsworth Center, New York State Department of Health, located in Albany, is the country’s most comprehensive state public health laboratory with a staff of about 800 that includes over 100 doctoral level scientists. The Center provides a unique combination of public health and research in a dynamic environment focused on infectious, genetic and environmental diseases and their impact on human health. To learn more, please visit https://www.wadsworth.org/
Forward-Looking Statements:
This press release contains “forward-looking statements” concerning the development, performance 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.