Applied DNA Receives New York State Department of Health Conditional Approval for Linea™ 2.0 COVID-19 Assay as Laboratory Developed Test

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– Company Also Announces Intention to File Near-Term EUA Request with FDA for Linea 2.0 Assay and Recently Developed, Unsupervised, At-Home Sample Collection Kit to Expand Addressable Market and Scope of COVID-19 Testing Services – STONY BROOK, N.Y.–(BUSINESS WIRE)–$APDN #COVID19Testing—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 (ADCL), has received conditional approval from the New York State Department of Health (NYSDOH) for its Linea™ 2.0 Assay (the “Linea 2.0 Assay”) as a Laboratory Developed Test (LDT), pending a final review of the assay’s validation data by NYSDOH. With the conditional approval, ADCL can immediately employ the Linea 2.0 Assay for COVID-19 testing to support New York State-based safeCircle™ clients for the diagnostic testing of COVID-19. The Linea 2.0 Assay is conditionally approved for individual and pooled (up to 5-samples) testing. Concurrently, ADCL announced its intention to submit a request for EUA to FDA for the Linea 2.0 Assay and a recently developed unsupervised at-home sample collection kit that, if authorized under EUA, would allow for the service of safeCircle clients beyond ADCL’s New York-centric operating area and to support an expansion of safeCircle’s scope of COVID-19 testing services to include enterprise-based, unsupervised at-home sample collection programs, such as those anticipated under the OSHA ETS (Emergency Temporary Standard). The Linea 2.0 Assay is a 3-target, multiplexed, real-time reverse transcription polymerase chain reaction (rRT-PCR) assay targeting conserved regions of the SARS-CoV-2 Envelope (E) and Nucleocapsid (N) genes and the human RNase P gene in respiratory specimens. The Linea 2.0 Assay was designed as an evolution of the Company’s Linea 1.0 COVID-19 Assay (the “Linea 1.0 Assay”), which powered safeCircle testing prior to the onset of the Omicron…

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Source : Applied DNA Receives New York State Department of Health Conditional Approval for Linea™ 2.0 COVID-19 Assay as Laboratory Developed Test

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