STONY BROOK, N.Y.–(BUSINESS WIRE)–Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced the launch of its Linea™ COVID-19 Selective Genomic Surveillance™ (SGS) Mutation Panel (the “SGS Panel”) to enhance the utility of limited Next Generation Sequencing (NGS) resources in the United States to track better the SARS-CoV-2 Variants of Concern (VOCs) at local, state, and federal levels. The SGS Panel uses a matrix of proprietary quantitative polymerase chain reaction (qPCR) assays that target salient mutations that characterize relevant identified VOCs to narrow the selection of positive samples worth subjecting to NGS analysis, which is the only method of conclusively identifying a specific variant. The Company is targeting SGS Panel sales at state and federal government laboratories, hospitals, academic institutions, and certified diagnostic laboratories.
Applied DNA is leveraging existing sales channels to market the SGS Panel and recently launched a national ad campaign in Clinical Laboratory News and Genetic Engineering & Biotechnology News to support its marketing initiatives. Use of the SGS Panel is currently limited to research use only (RUO) and is not meant to be diagnostic. The Company will be offering for sale both the SGS Panel (RUO) in 100 reaction kits and the Company’s EUA-authorized Linea™ COVID-19 Assay Kit (the “Assay Kit”) that can detect certain variants via S-gene dropout. The Company believes the combination of the SGS Panel and Assay Kit forms a robust decision matrix to empower the efficient use of NGS resources. The Company is also planning to offer additional RUO services that include NGS sequencing of entire viral genomes. The Company is targeting the sequencing of 100 SARS-CoV-2 viromes per day with a capacity for twice that number.
Tracking and containing variant spread is especially important as the population builds national immunity via the vaccine rollout. In addition, understanding variant impact on those vaccinated or previously infected by SARS-CoV-2 is essential to the design of variant vaccine boosters or the revision of monoclonal antibody therapies to address new variant antigens.
Dr. James Hayward, president and CEO of Applied DNA, stated, “The lack of NGS gene sequencing capacity in the U.S. with which to confirm specific variant identity is creating a demand for easy-to-use and cost-effective positive sample prescreening tools to supplement and strengthen the NGS capacity of participating laboratories. As the epidemiological threat changes with the arrival of new lineages, or as the dominant VOC lineages evolve mutations that are naturally selected for improved viral fitness, the need to sequence samples via NGS will continue to grow and put further strain on the nation’s finite NGS capacity. We believe the best way to efficiently allocate this important national resource is to select only valuable samples for sequencing via the use of a qPCR decision matrix powered by our SGS Panel and Assay Kit. We believe that the identification of known VOCs and new variants from other phylogenetic paths is essential to containing the spread of COVID-19, even – and especially – in the face of a successful vaccination campaign.”
About the Linea COVID-19 Assay Kit and the Linea COVID-19 Selective Genomic Surveillance™ (SGS) Mutation Panel
The Linea™ COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the Linea™ COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The Linea™ COVID-19 Selective Genomic Surveillance™ (SGS) Mutation Panel (the “SGS Panel”) is for Research Use Only (RUO) and shall not be used for clinical diagnostic purposes. The SGS Panel has not been approved or authorized to diagnose, ameliorate and/or detect any disease by any U.S. or international regulatory authority. In addition, all NGS services to be offered by the Company will be for Research Use Only (RUO).
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. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.
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.
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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 the assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, 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 17, 2020, and Form 10-Q filed on February 11, 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.