NEW YORK — Quotient Limited said on Monday that it has received Emergency Use Authorization (EUA) from the US Food and Drug Administration for a SARS-CoV-2 antibody test designed to run on the company's MosaiQ platform for blood grouping and transfusion-transmitted infection screening.
The test, which was CE marked in early May, is designed to detect human immunoglobulin G and M antibodies against SARS-CoV-2. Quotient said that its automated MosiaQ system can process up to 3,000 of the antibody tests per day.
The Eysins, Switzerland-based company said that it has entered into several US supply contracts for the test including one with Bloodworks Northwest, a blood bank and research institute that aims to use convalescent blood plasma taken from COVID-19 patients as a treatment for the disease.
"Before granting the EUA, the FDA reviewed not only our COVID-19 antibody test but also the MosaiQ Instrument and related software," Quotient CEO Franz Walt said in a statement. "We are optimistic about the prospects for future FDA approvals of the other Quotient blood testing products in our pipeline."
Quotient anticipates receiving 510(k) clearance from the FDA for the MosiaQ system and a related serological disease screening microarray related in the first quarter of 2021.