Siemens Healthineers Adds Muscle To Global Antibody Testing Effort, In Talks With Vaccine Developers

Siemens Healthineers AG announced on 1 June that the US Food and Drug Administration has granted emergency use authorization (EUA) for its laboratory test to detect the presence of SARS-CoV-2 antibodies in blood. The test was CE marked last week and the company also plans to apply for 510(k) clearance for the test in the US to ensure the test is still available once the EUA is revoked.

Deepak Nath, president of laboratory diagnostics at Siemens Healthineers, told Medtech Insight in a 28 May interview that the company’s primary motivation was to answer societal need with a high-quality antibody test; it wasn’t a case of needing a business plan