BARDA partners with Quidel on test for COVID-19, other respiratory viruses

Biomedical Advanced Research and Development Authority (BARDA) and San Diego-based Quidel Corporation entered into a partnership to develop a rapid multi-analyte diagnostic test for use on the Sofia 2 assay system to detect the SARS-CoV-2 virus 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 COVID-19 infections, and take action to help decrease the number of infections in their communities.

The company will develop the Quidel Sofia SARS-CoV-2 viral antigen-detection assay as a rapid, sample-to-answer, point-of-care test that is CLIA [Clinical Laboratory Improvement Amendments] waived for possible use in doctors’ offices and sensitive enough for early detection of SARS-CoV-2 in samples taken from people who have COVID-19 symptoms. The test will also simultaneously detect and distinguish other viruses apart from SARS-CoV-2 including respiratory syncytial virus (RSV), influenza A and influenza B.

This SARS-CoV-2 test development project will use clinical respiratory specimen data for submission in the coming months to the U.S. Food and Drug Administration, for the FDA to consider Emergency Use Authorization.

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