The contract, which has a total award value of USD 18.2m, 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.
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 authorisation submissions with the US 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.
Utilising 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.
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.
Quanterix is a company that's digitising biomarker analysis with the goal of advancing the science of precision health.
The company said its digital health solution, Simoa, has the potential to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease.
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.
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