QuidelOrtho Receives FDA De Novo Classification for Two SARS-CoV-2 Antibody Tests: VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Test and VITROS® Immunodiagnostic Products Anti-SARS-Cov-2 IgG Test

First high-throughput, automated SARS-CoV-2 antibody tests brought to the US market using a traditional premarket review process

SAN DIEGO, CA - QuidelOrtho Corporation (NASDAQ: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today in collaboration with Biomedical Advanced Research and Development Authority (BARDA) that the U.S. Food and Drug Administration granted marketing authorization for both the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator, and VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack and Calibrator. The VITROS Total and IgG tests are the first high-throughput, automated SARS-CoV-2 Antibody tests permitted to market in the U.S. using a traditional premarket review process.

The antibody tests, which were among the first to receive Emergency Use Authorization (EUA) in 2020, were today granted marketing authorization using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. With these De Novo authorizations, the VITROS tests become the predicate device after which subsequent devices of the same type and intended use will be cleared.

“Our VITROS Anti-SARS-CoV-2 Total test and VITROS Anti-SARS-CoV-2 IgG test help assess immune response to SARS-CoV-2, to help healthcare workers and patients understand and manage this disease,” said Douglas Bryant, President and CEO of QuidelOrtho Corporation. “QuidelOrtho was the first company to receive de novo classification for SARS Antigen+ FIA and, just a few weeks later, is again the first to receive de novo classification for not one, but two COVID-19 Antibody tests, solidifying our expertise and leadership in diagnostic testing for respiratory diseases.”

Patients with SARS-CoV-2 infection produce antibodies to multiple viral antigens including the spike protein and the nucleocapsid protein. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total and VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG assays provide qualitative detection of total and IgG antibodies to the spike protein of SARS-CoV-2 in human samples as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2.

The VITROS Anti-SARS-CoV-2 Total assay and VITROS Anti-SARS-CoV-2 IgG assay are intended for the detection of antibodies to SARS-CoV-2 in human serum and plasma and are processed on QuidelOrtho’s VITROS® Systems.

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