Applied DNA Submits Request for Emergency Use Authorization to FDA for Linea™ 2.0 COVID-19 Assay and Linea™ Unsupervised At-Home Sample Collection Kit

Rhea-AI Summary

Applied DNA Sciences (NASDAQ: APDN) announced that its subsidiary, Applied DNA Clinical Labs, submitted a request to the FDA for Emergency Use Authorization for its Linea 2.0 COVID-19 Assay and Unsupervised At-Home Sample Collection Kit. If approved, this will expand its safeCircle COVID-19 testing platform nationally, aimed at minimizing workforce disruptions caused by COVID-19 spread. The Linea 2.0 Assay is variant agnostic and can detect all known SARS-CoV-2 variants, with results typically available within 24 to 48 hours.

Positive

• Request for Emergency Use Authorization for Linea 2.0 COVID-19 Assay submitted to FDA.
• Expansion of safeCircle COVID-19 testing platform could lead to increased demand and revenue.
• High-throughput multiplex RT-PCR assay can detect all known SARS-CoV-2 variants, enhancing efficacy.

Negative

• Approval from FDA is uncertain, which may delay expansion plans.
• Dependence on the timely approval of the EUA could affect operational continuity.

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, LLC (ADCL), has submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for its Linea™ 2.0 COVID-19 Assay (the “Linea 2.0 Assay”) and Linea™ Unsupervised At-Home Sample Collection Kit (the “Linea Collection Kit”).

If approved, the Company’s request for EUA positions ADCL to pursue an expansion of its established safeCircle™ COVID-19 testing platform nationally to meet the needs of enterprises seeking to protect workforce health and avoid disruptions to operations by mass staff absences due to Omicron’s high transmissibility and ability to evade vaccination immunity. ADCL's safeCircle program is a fully integrated testing platform for enterprise and educational institutions that provides a full range of COVID-19 diagnostic testing and associated services, including sample collection, test site infrastructure design and management, results tracking, and vaccination status management.

The Linea 2.0 Assay is a high-throughput multiplex RT-PCR assay targeting the E and N genes of SARS-CoV-2. The Assay is variant agnostic, can detect all known SARS-CoV-2 variants, and is validated for single sample and robotic pooled testing. The Assay previously received conditional approval from the New York State Department of Health in late December 2021. The Linea Collection Kit is designed to enable the simple self-collection of nasal swab specimens without supervision by medical personnel. Once collected, individual samples can be mailed directly back to ADCL or aggregated by a testing client and bulk shipped back to ADCL. Results are typically returned within 24-to-48 hours of a sample’s arrival at ADCL’s clinical lab.

“The unprecedented surge in COVID-19 cases driven by the Omicron variant, we believe, makes clear that the need for accurate and rapid PCR-based testing is more important than ever. We believe this EUA request positions us to service existing demand for enterprise-scale COVID-19 testing with a compelling selling proposition where remote work is not a scalable option and a dependence on less sensitive, antigen-based tests can potentially lead to outbreaks and interruptions in business continuity. Having proved the safeCircle platform in New York State, we are pursuing partnerships and contract opportunities to establish safeCircle nationally,” stated Dr. James A. Hayward, president and CEO of Applied DNA. “At the same time, while safeCircle was formed specifically to build a COVID-19 testing platform, the potential acquisition of a national customer base advances ADCL’s strategy to expand its diagnostic offerings beyond SARS-CoV-2 with an installed client base.”

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.

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, whether and when, if at all, the FDA will review any EUA request, disruptions in the supply of raw materials and supplies, continued mutations of the SARS-CoV-2 virus, 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/20220121005165/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 is the purpose of Applied DNA's EUA request for APDN?

Applied DNA is seeking Emergency Use Authorization for its Linea 2.0 COVID-19 Assay and Collection Kit to expand its COVID-19 testing services.

How does the Linea 2.0 Assay work in relation to COVID-19 testing for APDN?

The Linea 2.0 Assay is a high-throughput multiplex RT-PCR test that targets SARS-CoV-2 and is capable of detecting all known variants.

When was the EUA request submitted by Applied DNA Sciences for APDN?

The EUA request was submitted recently, although the specific date is not mentioned in the press release.

What are the future implications for APDN if the EUA is granted?

If granted, the EUA would allow ADCL to significantly expand its safeCircle COVID-19 testing offerings nationally.

What is the significance of the safeCircle program for APDN?

The safeCircle program is essential for providing integrated COVID-19 testing solutions for enterprises and educational institutions, aimed at maintaining workforce health.