BARDA and Tangen Biosciences, Inc. entered into a partnership to develop a rapid diagnostic test for use on the Tangen GeneSparkTM molecular diagnostic system to detect the SARS-CoV-2 virus with results available within an hour. Results are provided to users and integrated into a cloud-based mobile platform that can convey de-identified test results to public health agencies. This capability could help public health departments monitor the spread of the disease and decrease the number of infections in their communities.
The company will develop a test that is expected to be CLIA waived for use in doctors’ offices and is sensitive enough for early detection of SARS-CoV-2 in samples taken from the back of the nose or throat of people who have COVID-19 symptoms. The Tangen Dx SARS-CoV-2 uses a manual workflow followed by amplification and detection on the GeneSparkTM nucleic acid amplification instrument. Turnaround time from sample collection to result is approximately one hour per sample. Upon successful development, the company will seek Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
About the Company:
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
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 include Candida auris, sepsis causing bacteria, antibiotic resistance genes, and a Candida blood panel.