Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, announced today that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for its Linea™ 2.0 COVID-19 Assay (the "Linea 2.0 Assay") and Linea™ Unsupervised At-Home Sample Collection Kit (the "Linea Collection Kit").
If approved, the Company’s request for EUA positions ADCL to pursue an expansion of its established safeCircle™ COVID-19 testing platform nationally to meet the needs of enterprises seeking to protect workforce health and avoid disruptions to operations by mass staff absences due to Omicron’s high transmissibility and ability to evade vaccination immunity. ADCL's safeCircle program is a fully integrated testing platform for enterprise and educational institutions that provides a full range of COVID-19 diagnostic testing and associated services, including sample collection, test site infrastructure design and management, results tracking, and vaccination status management.
The Linea 2.0 Assay is a high-throughput multiplex RT-PCR assay targeting the E and N genes of SARS-CoV-2. The Assay is variant agnostic, can detect all known SARS-CoV-2 variants, and is validated for single sample and robotic pooled testing. The Assay previously received conditional approval from the New York State Department of Health in late December 2021. The Linea Collection Kit is designed to enable the simple self-collection of nasal swab specimens without supervision by medical personnel. Once collected, individual samples can be mailed directly back to ADCL or aggregated by a testing client and bulk shipped back to ADCL. Results are typically returned within 24-to-48 hours of a sample’s arrival at ADCL’s clinical lab.
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