Applied DNA Receives New York State Department of Health Conditional Approval for Linea™ 2.0 COVID-19 Assay as Laboratory Developed Test
- 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 -
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
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.
Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-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
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW.’
Applied DNA is a member of the Russell Microcap® Index.
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, the possibility that Applied DNA’s assay kits or testing services could become obsolete or have its utility diminished and the unknown amount of revenues and profits that will results from Applied DNA’s testing contracts. Further, the uncertainties inherent in research and development, future data and analysis, including whether any of Applied DNA’s or its partner’s future diagnostic candidates will advance further in the research process or receiving authorization, clearance or approval from the FDA, equivalent foreign regulatory agencies and/or the