BILLERICA, Mass.--(BUSINESS WIRE)--Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced that it has entered into a Phase 2 contract with the National Institutes of Health (NIH) through its Rapid Acceleration of Diagnostics (RADx℠) initiative. The contract, which has a total award value of $18.2 million, will accelerate the continued development, scale-up and deployment of a novel SARS-CoV-2 antigen test based on Quanterix’ ultra-sensitive Simoa technology. Preliminary results indicate that the test has the potential to enable detection from a variety of sample types including self-collected capillary blood, saliva and nasal swabs.
“The need for accurate and reliable testing in response to the global COVID-19 pandemic continues, and we are honored to have been selected by the NIH to progress to Phase 2 of this important initiative,” said Kevin Hrusovsky, Chairman, Chief Executive Officer and President, Quanterix and Founder, Powering Precision Health (PPH).
Initial early feasibility of the test was funded in part through a RADx Phase 1 award. The Phase 2 contract supports clinical validation of the test in support of planned emergency use authorization (EUA) submissions with the U.S. Food and Drug Administration. The contract provides funding to expand assay kit manufacturing capacity at the Company’s Billerica, Massachusetts facility and commercial deployment readiness. Utilizing the Company’s high-throughput automated HD-X instrument platform, Quanterix intends to make the test available through a network of centralized third-party labs. Contract funding is subject to achievement of pre-defined milestones and the contract period runs through September 2021.
“We believe our technology, combined with the support of the NIH and the strength of our partnerships across the Powering Precision Health ecosystem, will help support the accelerated development and scaling of essential testing necessary to help win the fight against COVID-19,” continued Hrusovsky. “These investments support and complement advances we are making with unique and highly sensitive assay capabilities and technology in neurology, oncology and HIV. We look forward to accelerating our impact by applying these strengths toward COVID-19.”
This project has been funded in part by the RADx℠ initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. The current contract is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services.
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.