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Quanterix Gets FDA EUA for SARS-CoV-2 Antibody Test

NEW YORK – The US Food and Drug Administration has granted emergency use authorization for Quanterix's Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody test.

According to the FDA, the immunoassay is intended for qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and dipotassium EDTA plasma. The test runs on the Quanterix HD-X immunoassay analyzer and can be performed by labs certified under CLIA to run moderate- or high-complexity tests.

The FDA said that samples for the Quanterix test should only be tested from individuals that are 15 days or more post-symptom onset.

Quanterix was one of six firms to recently receive Phase 2 funding from the Biomedical Advanced Research and Development Authority through its Rapid Acceleration of Diagnostics (RADx) program to speed up development of SARS-CoV-2 tests. Quanterix received $18.2 million for its efforts to develop and antigen test.