FDA Expands Quanterix's COVID-19 Antigen Test Emergency Use Label

The FDA has expanded the Emergency Use Authorization (EUA) label for Quanterix Corporation's QTRX Simoa SARS-CoV-2 N Protein Antigen Test.
The expanded label will include testing with a nasal swab and saliva samples and asymptomatic serial testing with nasal swab samples.
The expanded label establishes this test as the first antigen test authorized for use with saliva samples.
The test is validated to detect all Variants of Concern currently designated by the Centers for Disease Control (CDC).
The test can run on Quanterix' Simoa HD-X Analyzer, a fully automated high-throughput immunoassay instrument.
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Related content: Benzinga's Full FDA Calendar.
Price Action: QTRX stock closed 3.61% lower at $46.21 on Monday.