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

Rhea-AI Summary

Applied DNA Sciences (NASDAQ: APDN) announced that its clinical lab, Applied DNA Clinical Labs (ADCL), has received conditional approval from the New York State Department of Health for its Linea 2.0 Assay for COVID-19 testing. The assay can be used for individual and pooled testing. Additionally, ADCL plans to file a request for Emergency Use Authorization (EUA) with the FDA for the assay and a new at-home sample collection kit, expanding its testing services beyond New York. The Linea 2.0 Assay targets SARS-CoV-2 genes and boasts enhanced performance over the previous version.

Positive

• Conditional approval received from NYSDOH for Linea 2.0 Assay, allowing immediate use for COVID-19 testing.
• Intention to file EUA request with FDA for Linea 2.0 Assay and a new at-home sample collection kit, potentially expanding market reach.
• Improved performance of Linea 2.0 Assay over its predecessor, enhancing testing efficiency.

Negative

• None.

- 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)-- 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 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.

Dr. James A. Hayward, president and CEO of Applied DNA, stated, “We are grateful to the NYSDOH for conditional approval of our Linea 2.0 Assay with which to combat Omicron infectivity in New York at a time when the variant is driving single-day COVID-19 cases to record levels almost daily. With our ability to support current and prospective New York State-based clients’ testing needs secured, we set our sights on national testing needs and opportunities for population-scale testing that we believe can benefit from greater access to PCR-based testing with 28–48-hour turnaround that, paired with a digital health platform, makes safeCircle a timely, accurate, and convenient COVID-19 testing platform.”

About Applied DNA Sciences

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 Linea^TM SARS-CoV-2 Mutation Panel, an assay-based panel for the detection of certain SARS-CoV-2 genetic mutations.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

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.

Forward-Looking Statements

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 New York State Department of Health (NYSDOH), and whether and when, if at all, they will receive final authorization, clearance or approval from the FDA, equivalent foreign regulatory agencies and/or NYSDOH, the unknown outcome of any applications or requests to FDA, equivalent foreign regulatory agencies and/or the NYSDOH, the unknown limited duration of any EUAs from the FDA, changes in guidance promulgated by the CDC, FDA, CMS an/or NYSDOH relating to COVID-19 testing, disruptions in the supply of raw materials and supplies, continued mutations of the SARS-CoV-2 virus, shifting review priorities of FDA for COVID-19 EUA requests and when, if at all, any EUA request will be reviewed by FDA, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 9, 2021, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220103005290/en/

Investor Relations Contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com

safeCircle Program Manager: Mike Munzer, 631-240-8814, mike.munzer@adnas.com

Web: www.adnas.com

Twitter: @APDN

Source: Applied DNA Sciences, Inc.

FAQ

What recent approval did Applied DNA Sciences receive for its COVID-19 testing?

Applied DNA Sciences received conditional approval from the New York State Department of Health for its Linea 2.0 Assay.

What is the Linea 2.0 Assay used for?

The Linea 2.0 Assay is used for COVID-19 testing, capable of individual and pooled sample testing.

What are the future plans for the Linea 2.0 Assay by Applied DNA Sciences?

Applied DNA Sciences intends to submit a request for Emergency Use Authorization to the FDA for the Linea 2.0 Assay and an at-home sample collection kit.

How does the performance of the Linea 2.0 Assay compare to the previous version?

The Linea 2.0 Assay demonstrates improved performance compared to the Linea 1.0 Assay.

What is the ticker symbol for Applied DNA Sciences?

The ticker symbol for Applied DNA Sciences is APDN.