28.09.2020 13:31:15
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Quotient Granted EUA From FDA For Its COVID-19 Antibody Test - Quick Facts
(RTTNews) - Diagnostics company Quotient Ltd. (QTNT) announced Monday that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on Friday for its COVID-19 antibody test. Before granting the EUA, the FDA reviewed not only its COVID-19 antibody test but also the MosaiQ Instrument and related software.
The test detects antibodies generated in humans in response to the SARS-CoV-2 virus using Quotient's proprietary MosaiQ blood testing microarray technology.
The antibody test was CE marked on May 1, 2020 and is now available in Europe and the US. A single MosaiQ testing instrument can process up to 3,000 antibody tests per day.
As previously announced, Eysins, Switzerland-based Quotient has entered into contracts to supply its COVID-19 antibody tests to customers in the U.S. One of those customers, Bloodworks Northwest, is seeking to source convalescent blood plasma taken from donors whose blood contains SARS-CoV-2 virus antibodies, for use in treating COVID-19 patients.
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