Siemens Healthineers (ETR: SHL) announced today that it has secured an FDA emergency use authorization for its COVID-19 antibody test.
The news comes nearly a week after the German medtech giant said it had started worldwide shipments of the test — a laboratory-based total antibody test that can detect SARS-CoV-2 antibodies including IgM and IgG in blood. The company already has more than 1 million tests shipped to health systems and laboratories.
Antibody tests are an important tool as countries reopen their economies amid the COVID-19 pandemic: They can tell who has had the coronavirus in the past and hopefully developed some immunity. Siemens Healthineers, in fact, designed its Total Antibody COV2T assay to detect antibodies to the spike protein, which are believed to neutralize the SARS-CoV-2 virus and therefore prevent infection.
“As a leader in laboratory diagnostics, Siemens Healthineers designed a high-quality, highly accurate antibody test with the capacity and reach necessary to help address a critical societal need,” said Deepak Nath, president of Laboratory Diagnostics at the company.
“The test targets both IgM and IgG antibodies, which allows for early identification of individuals infected with the virus who have developed an immune response, even if they were asymptomatic or never diagnosed with the disease,” Nath said in a news release.
Siemens Healthineers officials say the company’s antibody tests demonstrate 100% sensitivity (ability to exclude false negatives) and 99.8% specificity (few false positives) in identifying SARS-CoV-2 antibodies in as few as 10 minutes.
Siemens Healtineers is making the tests in Walpole, Mass. and Newark, Del., and distributing them out of Plainfield, Ind. It’s ramping up production, with with a goal of manufacturing capacity exceeding 50 million tests per month across its testing platforms.