NIH will provide $18.2m in Phase 2 funding to support the development and scale-up of COVID-19 antigen test based on Simoa technology
National Institutes of Health - Clinical Center south entrance view. (Credit: CZmarlin/Wikipedia.)
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.
Source: Company Press Release