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BARDA partners with Quidel Corporation to develop one-hour, mobile-integrated multiplex test on Sofia platform to detect SARS-COV-2 plus three additional respiratory viruses

BARDA Response

BARDA and 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 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.

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.

Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's recently acquired Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio, visit quidel.com.

Last Updated: June 02, 2020
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