BARDA, Tangen partner to develop rapid COVID-19 diagnostic test

The Biomedical Advanced Research and Development Authority (BARDA) and Branford, Connecticut-based Tangen Biosciences, Inc. have entered into a partnership to develop a rapid diagnostic test for use on the Tangen GeneSpark molecular diagnostic system to detect the SARS-CoV-2 virus.

Turnaround time from sample collection to result is approximately one hour per sample. 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 receive a Clinical Laboratory Improvement Amendment waiver 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. Upon successful development, the company will seek Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

Read more: https://www.medicalcountermeasures.gov/newsroom/2020/tangen-diagnostic/