Quanterix Receives FDA Emergency Use Authorization for Semi-Quantitative Antibody Test
Quanterix Corporation (NASDAQ: QTRX) announced that the FDA granted Emergency Use Authorization (EUA) for its Simoa® Semi-Quantitative SARS-CoV-2 IgG Antibody Test, which operates on the Simoa HD-X Analyzer. This test measures the antibody response to the coronavirus spike protein and is vital for assessing immunity from COVID-19 vaccines and previous infections. Clinical studies indicate a sensitivity of 100% and specificity of 99.2%, supporting its reliability. Quanterix aims to aid COVID-19 immunology studies and enhance disease detection.
- FDA granted Emergency Use Authorization for Simoa® Semi-Quantitative SARS-CoV-2 IgG Antibody Test.
- Test demonstrates 100% sensitivity and 99.2% specificity in clinical studies.
- None.
Quanterix Corporation (NASDAQ: QTRX), 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.”
Simoa Technology
Simoa (single molecule array technology) is a revolutionary digital approach to immunoassays which allows single molecules to be counted for protein biomarker research applications, changing the way in which the biology of health and disease is studied by giving scientists the ability to closely examine critical biomarkers. In doing so, Quanterix enables development of methods providing much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for applications in a majority of therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease.
Simoa RUO assays for COVID-19 Research
The Quanterix catalog of research use only products and technologies for COVID-19 research includes a broad range of ultra-sensitive protein biomarker assays comprising critical immunomodulatory cytokines and chemokines, cardiac stress proteins and key biomarkers of neurological damage including neurofilament light all from minimally invasive blood samples.
For more information on Quanterix’ Simoa technology, visit https://www.quanterix.com/technology. To learn more about Quanterix’ infectious disease research and RUO assay development solutions, visit https://www.quanterix.com/therapeutic-areas/infectious-disease.
About Quanterix
Quanterix is a company that’s digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa®, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease. Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation a
