Applied DNA Sciences, Inc. announced 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 variant.

The performance of the Linea 2.0 Assay exceeds the performance of the Linea 1.0 Assay and allows ADCL to leverage its proven laboratory workflows to provide rapid and cost-effective testing to its safeCircle customers.