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


Benzinga | Sep 14, 2021 07:40AM EDT

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 (NASDAQ: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.

* Related Link: Why Cassava Sciences Stock Investors Are Pulling Back.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: QTRX stock closed 3.61% lower at $46.21 on Monday.







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