NEW YORK – Tangen Biosciences has been awarded a $696,000 contract from the Biomedical Advanced Research and Development Authority to develop a point-of-care molecular diagnostic assay for the SARS-CoV-2 virus.
The test would run on Tangen's GeneSpark nucleic acid amplification system and would be sensitive enough for early detection of the virus from nasopharyngeal samples in about an hour. It would also be expected to garner a CLIA waiver for use in doctors' offices.
Upon successful development, Branford, Connecticut-based Tangen is expected to seek Emergency Use Authorization from the US Food and Drug Administration.
Tangen's GeneSpark platform comprises the TangenDx disc and GeneSpark instrument, and performs rotary rapid isothermal nucleic acid amplification and detection. The platform currently features tests for Candida auris, sepsis-causing bacteria, and antibiotic resistance genes, as well as a Candida blood panel.
The company was previously awarded approximately $7 million in two phases from BARDA to develop a point-of-care molecular test for anthrax and a blood-based panel for antibiotic resistance markers.