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Applied DNA Sciences (APDN) Granted FDA Emergency Use Authorization for COVID-19 Diagnostic Assay Kit

May 14, 2020 6:12 AM EDT

Applied DNA Sciences Inc. (NASDAQ: APDN) announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the clinical use of the Companys patent-pending Linea COVID-19 RT-PCR test for COVID-19. Clinical laboratories in the United States certified under Clinical Laboratory Improvement Amendments (CLIA) to perform hi complexity tests. CLIA labs can immediately begin ordering and using the Linea COVID-19 assay kit to detect SARS-CoV-2, the virus that causes COVID-19.

The Linea COVID-19 assay kit is an rRT-PCR (reverse transcription, Real Time Polymerase Chain Reaction)-based assay designed... More