DiaSorin Gets FDA Emergency-Use Rights for Covid-19 Test in U.S.
DiaSorin SpA received Emergency Use Authorization from the U.S. Food and Drug Administration for a new serologic test for Covid-19.
The Liaison test is one of the first based on so-called Chemiluminescent ImmunoAssay technology to receive such authorization in the U.S., DiaSorin said Saturday in a statement. The Italian company is boosting output capacity at its Saluggia site to make several million Liaison tests in the coming months.
Earlier in April, DiaSorin said it had “CE-marked” the test, known formally as Liaison Sars-Cov-2 S1/S2 IgG, and was submitting the product to the FDA for authorization.
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