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Eurofins Technologies Gets CE-IVD Marking for Coronavirus Serology Tests

NEW YORK — Eurofins Technologies said on Tuesday that it has received CE-IVD marking for three ELISA-based tests for SARS-CoV-2.

The NovaLisa SARS-CoV-2 tests are designed to qualitatively detect virus-associated immunoglobulin A, immunoglobulin G, and immunoglobulin M antibodies, respectively, in human serum.

Budapest-based Eurofins Technologies — a subsidiary of Eurofins Scientific — said that the tests demonstrated very high specificity in initial testing on more than 200 healthy and potentially cross-reacting samples. They were developed in collaboration with Eurofins Scientific subsidiaries Gold Standard Diagnostics, Virotech Diagnostics, NovaTec Immundiagnostica, and Inmunologia Y Genetica Aplicada.

"Eurofins Technologies companies will immediately start shipments [of the tests] in significant quantities and we will at the same time offer these tests as a service in Eurofins clinical laboratories around the world," Eurofins Scientific Chairman and CEO Gilles Martin said in a statement. "Our four factories and partners are ramping up to produce kits to carry out over 10 million tests per month."