FDA grants re-issued EUA for COVID-19 test kit

May 13, 2021

Applied DNA Sciences announced that the U.S. Food and Drug Administration (FDA) has granted a re-issued emergency use authorization (EUA) that expands the intended use of the company’s Linea COVID-19 Assay Kit to include serial screening of asymptomatic individuals.

The expanded intended for the PCR test allows for the serial testing of individuals with or without symptoms, eliminates the prescription requirement, and returns results to individuals.

Separately, the company received CLIA certification for its Applied DNA Clinical Labs, LLC (ADCL) subsidiary.

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