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antibody-based diagnostics

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.

The firm reported $57.8 million in revenues for its Lyra SARS-CoV-2 molecular diagnostic assays in the quarter.

Kantaro said that authorized clinical testing laboratories in Europe can use its enzyme-linked immunoassays, which detect IgG antibodies to two coronavirus antigens.

The collaboration will involve the evaluation of serological tests to detect the durability of patients' immune response to COVID-19.

The test could also be used to assess vaccine effectiveness, should a vaccine become available.

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.

Quidel's preliminary earnings more than doubled over the prior quarter on increasing SARS-CoV-2 test sales.

The FDA has authorized the Assure COVID-19 IgG/IgM Rapid Test Device for use on fingerstick blood samples.