Therapy Areas: Respiratory
Applied DNA Receives New York State Department of Health Conditional Approval for Linea 2.0 COVID-19 Assay as Laboratory Developed Test
5 January 2022 - - US-based DNA manufacturing and nucleic acid-based technologies company Applied DNA Sciences, Inc's (NASDAQ: APDN) Applied DNA Clinical Labs subsidiary has received conditional approval from the New York State Department of Health (NYSDOH) for its Linea 2.0 Assay as a Laboratory Developed Test, pending a final review of the assay's validation data by NYSDOH, the company said.

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, 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.

Applied DNA is commercializing LinearDNA, its proprietary, large-scale polymerase chain reaction -based manufacturing platform that allows for the large-scale production of specific DNA sequences.

The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market.

The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies.

The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology.

Key end-markets include textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.

Leveraging its deep expertise in nucleic acid-based technologies, the company has also established safeCircle, a high-throughput turnkey solution for population scale COVID-19 testing.

safeCircle is designed to look for infection within defined populations or communities utilizing high throughput testing methodologies that increase testing efficiencies and provide for rapid turn-around-times.

The company has also submitted a request for an EUA-authorization for its LineaTM SARS-CoV-2 Mutation Panel, an assay-based panel for the detection of certain SARS-CoV-2 genetic mutations.
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