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Diazyme Gets CE-IVD Mark for Coronavirus Neutralizing Antibody Test

NEW YORK — Diazyme Laboratories said on Tuesday that it has received the CE-IVD mark for its SARS-CoV-2 neutralizing antibody test.

According to Diazyme, the high-throughput chemiluminescent immunoassay is designed to measure the subset of neutralizing antibodies that block the interaction between the receptor binding domain of the SARS-CoV-2 spike glycoprotein and the human ACE2 cell surface receptor.

"The Diazyme neutralizing antibody test gives the scientific community and health authorities a valuable tool to evaluate the level of effective antibodies generated after infection or vaccination and to assess adaptive immunity in studies going forward," Diazyme Managing Director Chong Yuan said in a statement.       

Diazyme said it intends to pursue US Food and Drug Administration Emergency Use Authorization for the test.

Last year, Poway, California-based Diazyme received separate EUAs from the FDA for its Diazyme DZ-Lite SARS-CoV-2 IgM and Diazyme DZ-Lite SARS-CoV-2 IgG antibody tests.