The firm submitted a new Emergency Use Authorization application to the FDA for a serology IgM/IgG test for SARS-CoV-2 after the agency revoked an earlier EUA for a similar test.
The company plans to launch a test that leverages unfolded p53 as a biomarker for detection by mass spectrometry in a US-based CLIA-certified lab late next year.
The order is the first from a European government following CE-IVD mark in September. The firm expects to ship 1.2 million of the assays by mid-November.
Kantaro said that authorized clinical testing laboratories in Europe can use its enzyme-linked immunoassays, which detect IgG antibodies to two coronavirus antigens.
Semi-quantitative SARS-CoV-2 serology tests enable users to measure levels of neutralizing antibodies, but tests need to be more comparable across manufacturers, Siemens said.
