Quanterix Receives FDA Emergency Use Authorization for Semi-Quantitative Antibody Test

Tuesday, December 29, 2020

Quanterix Corporation, a company digitizing biomarker analysis to advance the science of precision health, today announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its Simoa® Semi-Quantitative SARS-CoV-2 IgG Antibody Test that can be run on the Simoa HD-X Analyzer®, a fully automated high-throughput immunoassay instrument.

The Simoa Semi-Quantitative SARS-CoV-2 antibody test targets antibodies that are directed against the region of the novel coronavirus known as the spike protein. The spike protein contains multiple subunits which together mediate entry of the virus into human cells, and for this reason candidate and authorized COVID-19 vaccines are designed to elicit an antibody response to spike protein. The Simoa Semi-Quantitative SARS-CoV-2 may therefore be useful for measuring the antibody response to vaccine therapy. The assay may also be used for measurement of IgG antibodies in patients suspected of previous infection or recent SARS-CoV-2 exposure. The test provides a numerical result representing the concentration of antibodies from 0.21 to 250 μg/mL. In clinical studies, the test demonstrated a 100 percent positive percent agreement (sensitivity) and 99.2 percent negative percent agreement (specificity) 15 or more days following a positive PCR test.

“There is an apparent need for precise, accurate and reliable testing at each stage of this global pandemic including measuring serological response to vaccines,” said Kevin Hrusovsky, Chairman, Chief Executive Officer and President, Quanterix and Founder, Powering Precision Health (PPH). “With our deep understanding of precision medicine and digital biomarker technology we are committed to supporting the full study of COVID-19 immunology including the ability to measure the level of a person’s infection or vaccine-induced immune response as well as to support the development of convalescent plasma therapies. This EUA underscores our longstanding science-first mentality and deep dedication to the highest standards of quality and scientific rigor across our business.”

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