The German medtech giant also announced that FDA has granted an emergency use authorization for its PCR Fast Track Diagnostics (FTD) SARS-CoV-2 Assay6 test kit.
Both types of tests are important: Antibody tests can tell who has had the coronavirus in the past and hopefully developed some immunity, while people need diagnostics tests to tell whether they are experiencing a COVID-19 infection right now.
Siemens 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. The tests have a CE Mark in the EU, and Siemens is seeking an FDA EUA.
Siemens boasts that it has 20,000 systems worldwide to run the tests, including what it describes as the largest analyzer installed base in the U.S. Siemens Healthineers is increasing test production at its Walpole (Walpole, Mass.) and Glasgow (Newark, Del.) facilities so that it can exceed 50 million tests per month starting in June.
“Not all antibody tests are created equal. A high-quality test that targets the right protein and is highly scalable is essential for antibody testing to help ensure we effectively manage the threat of COVID-19,” said Deepak Nath, president of Laboratory Diagnostics at Siemens Healthineers.
“Siemens Healthineers sought to provide a highly accurate antibody test that could reach millions of people to address the current need for identifying immune response, and also for delivering long-term value as we look toward immunity and vaccination,” Nath said in a news release.
When it comes to the COVID-19 diagnostic tests, Siemens Healthineers has already sold 500,000 in Europe. The test is compatible with many lab platforms and evaluates two targets in one test tube — detecting two genes with less test preparation. Sample-to-answer time takes 2-3 hours depending on the molecular system and lab resources employed.
“I’m proud of our team who saw the societal need and mobilized very quickly to bring this high-quality, diagnostic test to the U.S. market,” Nath said.
Siemens Healthineers plans to ship more than 2.5 million molecular PCR tests per month worldwide as production capacity increases in May and June.