Quanterix Receives FDA Emergency Use Authorization for Semi-Quantitative Antibody Test
Antibody test available on Simoa HD-X Analyzer® detects and quantitates IgG antibodies to SARS-CoV-2 in serum or EDTA plasma
BILLERICA, Mass., December 28, 2020 – 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 mg/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 (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.
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 and infectious disease. The company was established in 2007 and is located in Billerica, Massachusetts. For additional information, please visit https://www.quanterix.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release are based on Quanterix’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause Quanterix’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix’ filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, Quanterix assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Stephen Hrusovsky, 774-278-0496
Staci Didner, 617-502-4300