NEW YORK ─ The US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority announced Monday that it has awarded funding to Quidel and Siemens Healthineers for the development of SARS-CoV-2 tests.
BARDA awarded $634,643 to Quidel for the development of a four-analyte antigen test on the firm's Sofia 2 point-of-care, multiplex, fluorescent, immunoassay platform. Quidel will develop the test to detect SARS-CoV-2, respiratory syncytial virus, influenza A, and influenza B. The sample-to-answer, point-of-care assay is being developed to be CLIA waived enabling possible use in doctors’ offices and to be sensitive enough for the early detection of SARS-CoV-2 in samples from people who have COVID-19 symptoms, BARDA said.
A cloud-based mobile platform will convey de-identified test results to public health agencies, which could help public health departments monitor the spread of COVID-19 infections and help decrease the number of infections in their communities, BARDA said.
Clinical respiratory specimen data from the test development project will form the basis of a US Food and Drug Administration Emergency Use Authorization submission in the coming months, BARDA said.
San Diego-based Quidel had received an FDA EUA in May for the Sofia 2 SARS Antigen FIA test for the detection of the novel coronavirus, the first protein-based antigen test to receive such an authorization.
BARDA further announced it has awarded $602,275 to Erlangen, Germany-based Siemens Healthineers for the continued development of its SARS-CoV-2 total antibody test.
The lab-based total antibody test can be used to detect the presence of both SARS-CoV-2 IgM and longer-lasting IgG antibodies, BARDA noted. Serology-based tests such as the SARS-CoV-2 total antibody test can be used to indicate a recent or prior infection.
Siemens Healthineers' Atellica IM SARS-CoV-2 Total test and the Advia Centaur SARS-CoV-2 Total test were granted FDA EUAs at the end of May.