BRANFORD, Conn.–(BUSINESS WIRE)–Tangen Biosciences, Inc., an innovative developer of rapid, portable, and Point-of-Care diagnostics, today announced that the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) has awarded TangenTM the Second Option of a contract to develop a molecular diagnostic platform that can be used by the company to rapidly develop infectious disease tests. Last week, BARDA also announced that Tangen was awarded a separate contract to develop a rapid SARS-CoV-2 test for the detection of COVID-19 infection utilizing Tangen’s platform.
The molecular diagnostic platform development contract was initially awarded in September 2017 with the objective of developing a rapid, highly sensitive Point-of-Care assay for Anthrax. The Base Period and the First Option were valued at $7 million and the newly funded Second Option, starting in May 2020, is valued at $3.3 million. With BARDA’s support, Tangen successfully delivered the milestones set from the First Option and is now entering into the Second Option of the contract – to conduct a clinical trial for a bloodstream Anthrax diagnostic using the fully developed and integrated TangenDxTM platform. Tangen intends to submit a 510(k) premarket notification to FDA for the TangenDx – Anthrax assay and Tangen’s GeneSparkTM instrument before the end of 2020.
Tangen achieved extremely high sensitivity for detection of Anthrax from a blood sample. Independent testing at Battelle Memorial Institute demonstrated that the TangenDx – Anthrax assay consistently detected Anthrax virulence genetic markers with sensitivity lower than 10 CFU/ml, directly from whole blood samples in less than one hour. In addition, this contract funded the development of a prototype antimicrobial-resistant gene panel that demonstrated the multiplexing capability of amplifying multiple targets within one sample in a single run. This set the foundation for the Tangen – Antimicrobial Resistant Panel which targets the diagnosis of bloodstream bacterial infection and associated resistant genes in one hour directly from whole blood, without the need for blood culture.
Under a separate contract with BARDA, Tangen is developing its TangenDx – COVID-19 assay, which will run on Tangen’s GeneSparkTM instrument, funded by the BARDA contract mentioned above. The new contract will be used to develop a Point-of-Care SARS-CoV-2 diagnostic assay for FDA Emergency Use Authorization. Tangen’s COVID-19 assay is designed to use respiratory specimens in CLIA-waived settings.
“The BARDA funding has contributed to the creation of a small, portable yet very powerful molecular diagnostic Point-of-Care platform. The GeneSparkTM instrument is designed to enable rapid drop in assay development with the flexibility built into the manufacturing at our facility in Branford CT.” John Davidson, Ph.D., Co-founder and Chief Scientific Officer of Tangen stated. “We hope to bring our instrument and COVID-19 test to nursing homes, quarantine facilities, retail clinics, urgent care, doctor’s offices, wherever it is needed.”
The Anthrax 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.
The COVID-19 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. 75A50120C00085.
About Tangen Biosciences:
Tangen Biosciences, Inc. was founded in 2013 and is located in Branford, Connecticut. The company developed the TangenDx™ platform for fast and accurate detection of targeted DNAs and RNAs directly from specimens by using rotary rapid isothermal nucleic acid detection. The Tangen system consists of the TangenDx™ disc and the GeneSpark™ instrument, an automated amplification device. The TangenDx™ platform does not require laboratory facilities and will 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 TangenDx platform is on track for infectious disease clinical studies. To learn more, please visit: https://tangenbio.com/
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. Tangen Biosciences undertakes no obligation to update any forward-looking statements.