Research & Development
Quanterix wins FDA's expanded EUA label for Simoa SARS-CoV-2 N Protein Antigen Test
14 September 2021 -

Health solution company Quanterix Corporation (NASDAQ:QTRX) said on Monday that the Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) label for its Simoa SARS-CoV-2 N Protein Antigen Test to include testing with nasal swab and saliva samples as well as asymptomatic serial testing with nasal swab samples.

The expanded label establishes the company's Simoa SARS-CoV-2 N Protein Antigen Test as the first antigen test authorized for use with saliva samples. The test is validated to detect all Variants of Concern and is the first non-NGS test validated and independently confirmed to detect the highly transmissible Delta variant (B.1.617.2) in sequence-confirmed clinical samples.

According to the company, the test can be run on its Simoa HD-X Analyzer, a fully automated high-throughput immunoassay instrument. The Simoa SARS-CoV-2 N Protein Antigen Test detects the presence of the SARS-CoV-2 virus nucleocapsid protein (or N protein), which is known to be elevated in respiratory fluids during the initial acute phase of the infection.

In conjunction, the expanded US FDA authorization of the company's Simoa SARS-CoV-2 N Protein Antigen Test is an important next step in a project funded by the NIH Rapid Acceleration of Diagnostics (RADx) initiative to apply Simoa digital biomarker technology to decentralized SARS-CoV-2 antigen detection in non-invasive sample types to increase the capacity of SARS-CoV-2 testing in the US.

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