A new multi-matrix COVID-19 test based on ultra-sensitive technology will be able to detect the SARS-CoV-2 virus in its earliest stages, days before symptoms appear, thus filling the urgent need for asymptomatic screening.

Quanterix (Billerica, MA, USA) plans to file Emergency Use Authorizations (EUAs) for its assays involving multiple COVID-related biomarkers, based on its Simoa technology. Quanterix' proprietary Simoa technology is based on the isolation of individual immunocomplexes on paramagnetic beads using standard ELISA reagents. It gives researchers the ability to closely examine critical biomarkers, enabling the development of methods providing much earlier disease detection, better prognoses and enhanced treatment methods.

Currently, the Quanterix Simoa technology enables researchers to measure baseline levels of important cytokines and chemokines (such as IL-6, TNFα, IL-8 and even low abundance IFNα and IL1β) well above limits of quantification and directly in blood. Measuring early levels of these biomarkers during acute infection can deepen the understanding of cytokine storm onset and related cardiopulmonary and neurological damage. Simoa allows measurement of trace levels of IFNα, which enables separation of bacterial from viral infections, characterization of lupus samples and now following COVID-19 patients IFNα profile and assess type I interferon treatment options.

Quanterix’s newest COVID-19 assay based on its ultra-sensitive Simoa technology is currently being used as a lab-developed test at CLIA labs pending the FDA’s consideration of the company’s EUA application. Quanterix has received a funding of USD 18.2 million from the National Institutes of Health (NIH) to accelerate the continued development, scale-up and deployment of its novel SARS-CoV-2 antigen test based on its ultra-sensitive Simoa technology. The phase 2 contract supports the test's clinical validation in preparation for emergency use authorization submissions with the US Food and Drug Administration. Preliminary results showed the test has the potential to enable the detection of SARS-CoV-2 from sample types, including self-collected capillary blood, saliva and nasal swabs. The contract provides funding to expand assay kit manufacturing capacity 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.

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