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Applied DNA and Cytocheck Detect First Instance of SARS-CoV-2 B.1.1.7 Variant in Kansas

STONY BROOK, N.Y. & PARSONS, Kansas–()–Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, and Cytocheck Laboratory, LLC (Cytocheck), an anatomic and clinical pathology laboratory, today reported that Cytocheck identified the first instance of a SARS-CoV-2 variant in Kansas that was subsequently confirmed as lineage B.1.1.7 (the “UK variant”) by the Kansas Department of Health and Environment (KDHE) on February 3, 2021. Cytocheck utilizes Applied DNA’s Linea™ COVID-19 Assay Kit (the “Assay Kit”) in a genomic surveillance modality that screens virus-positive samples for the 69-70del mutation found in several variants, including the UK variant, that is characterized by increased transmissibility.

Genomic surveillance seeks to monitor positivity for variant spread to inform public health decisions. The lack of gene sequencing capacity in the U.S. with which to confirm variant spread is creating demand for tools to supplement and strengthen the sequencing capacity of participating laboratories nationally. Using the Assay’s Kit S-gene dropout in the presence of certain SARS-CoV-2 mutations, laboratories like Cytocheck can use Applied DNA’s Assay Kit to identify virus-positive samples that may be a SARS-CoV-2 variant. Once identified, those samples then undergo gene sequencing at participating laboratories, thereby making more rational use of limited gene sequencing capacity. Applied DNA believes that the multi-S-gene-target design of its Assay Kit gives it a substantial advantage in the detection of certain variants.

“The UK and Denmark have successfully used a molecular test that experiences S-gene dropout in the presence of the 69-70del mutation to deploy mass genomic surveillance to inform their public health decisions. We believe our Assay Kit, which experiences similar S-gene dropout, can set the same standard for genomic surveillance in the U.S.,” stated Dr. James A. Hayward, president and CEO, Applied DNA.

Commenting on the first detection of the UK variant in Kansas, Cytocheck President and Medical Director Dr. Ron Leonard, stated, “We are uniquely positioned to assist in the surveillance of emerging SARS-CoV-2 variants as we receive COVID-19 specimens for testing from three States. Integral to our workflow was bringing on an additional assay, the Applied DNA Linea™ COVID-19 Assay Kit, to screen our positive cases specifically looking for “S-gene drop out” which could indicate a potential UK variant. Within the first 30 samples screened, a case with S-gene drop out was identified, sent to the KDHE laboratory for sequencing and confirmed to be the first B.1.1.7 variant found in Kansas.”

About the LineaTM COVID-19 Assay Kit

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.

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 diagnostics and testing offering that is 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.

About Cytocheck Laboratory, LLC

Cytocheck Laboratory is an anatomic and clinical pathology laboratory located in Parsons, Kansas and is affiliated with MAWD Pathology of Kansas City.

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 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 other reports we file with the SEC, which are available at 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.


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