Quanterix Corporation (QTRX) this week announced signing of a phase 2 contract with the National Institutes of Health (NIH) through its Rapid Acceleration of Diagnostics (RADx) initiative.
To make the science of precision health more advanced, Quanterix is a company that digitizes biomarker analysis. With the total award value of $18.2 million, the contract is to utilize the ultra-sensitive Simoa technology of Quanterix to accelerate the continued development, scale-up and deployment of a novel SARS-CoV-2 antigen test. Initial outcomes of the test demonstrated that it could likely be enabling detection of the same from range of sample types. Those include self-collected nasal swabs, capillary blood and saliva.
Global presence of the COVID-19 pandemic still creates the need of reliable and accurate testing to respond to, and Quanterix is honored to have been selected by the NIH to continue into the next phase of this key initiative, said Chairman, Chief Executive Officer and President of Quanterix, Kevin Hrusovsky, who is also founder of Powering Precision Health (PPH).
Partial funding through RADx Phase 1 award made feasibility of the test in the initial stage possible. The Phase 2 contracts will be supporting the clinical validation of the testing. This will help in the plans of seeking approval for clinical testing through emergency use authorization (EUA) submissions with the U.S. Food and Drug Administration. The contract will also provide funding to increase the capacity of manufacturing assay kits at Quanterix’s Billerica, Massachusetts facility and will also make the company to align itself to commercially deploy the kits.
The company is intending making the test available through a network of centralized third-party labs utilizing its own high-throughput automated HD-X instrument platform. The contract will be valid till September 2021 and funding is subject to achievement of pre-defined goals.
The project is partially funded by RADx initiative in collaboration with National Institutes of Health and the National Institute of Biomedical Imaging and Bioengineering.