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BARDA expands partnership with DiaSorin Inc to develop an enhanced IgG assay for determining COVID-19 patient exposure and immune status

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BARDA has expanded its existing partnership with DiaSorin Inc. on the development of a COVID-19 immunoassay. The test detects the presence of antibodies to SARS-CoV-2 in human serum and plasma of a recently infected individual.

This test could help determine if someone lacks the antibodies against SARS-CoV-2 spike protein. If a COVID-19 vaccine receives approval or authorization from the U.S. Food and Drug Administration (FDA), this DiaSorin test also could provide critical information to individuals, such as essential workers and the immune compromised regarding their current immune status.

DiaSorin intends to develop, validate, manufacture, market, and obtain regulatory authorization in the United States and worldwide for this new, fully automated, chemiluminescent, immunoassay for the semiquantitative detection of IgG class antibodies against the SARS-CoV-2 virus in human serum and plasma. This assay is intended as an aid to determining patient exposure and immune status with respect to SARS-CoV-2 virus and COVID-19 disease.

About DiaSorin:

The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.

DiaSorin is a global leader in the laboratory diagnostics market, specializing in the immunodiagnostics and molecular diagnostics segments. For over 50 years DiaSorin Group has been developing, producing and commercializing diagnostic tests. DiaSorin supports clinical laboratory needs and activities, providing solutions that are reliable, innovative, fully automated and standardized. DiaSorin continually invests in Research & Development, using distinctive expertise in the field to deliver a high level of innovation. More information is available at https://www.diasorin.com.

Last Updated: November 16, 2020

COVID-19 Medical Countermeasure Portfolio

This award is one component of BARDA's rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA's COVID-19 Portfolio to learn more.

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