Benzinga | Jan 21, 2022 10:01AM EST

Applied DNA Submits Request For Emergency Use Authorization To FDA For Linea 2.0 COVID-19 Assay And Linea Unsupervised At-Home Sample Collection Kit

pplied 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(tm) 2.0 COVID-19 Assay (the "Linea 2.0 Assay") and Linea(tm) 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(tm) 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.

"The unprecedented surge in COVID-19 cases driven by the Omicron variant, we believe, makes clear that the need for accurate and rapid PCR-based testing is more important than ever. We believe this EUA request positions us to service existing demand for enterprise-scale COVID-19 testing with a compelling selling proposition where remote work is not a scalable option and a dependence on less sensitive, antigen-based tests can potentially lead to outbreaks and interruptions in business continuity. Having proved the safeCircle platform in New York State, we are pursuing partnerships and contract opportunities to establish safeCircle nationally," stated Dr. James A. Hayward, president and CEO of Applied DNA. "At the same time, while safeCircle was formed specifically to build a COVID-19 testing platform, the potential acquisition of a national customer base advances ADCL's strategy to expand its diagnostic offerings beyond SARS-CoV-2 with an installed client base."