Molecular Tagging of Pharmaceutical Drugs Utilizing Applied DNA’s Technology Published in Peer-Reviewed Journal

The paper summarizes a study in which a pharmaceutical manufacturer tagged acetaminophen capsules with pharmaceutical-grade ink containing a unique DNA tag produced by Applied DNA and its subsequent authentication. Study results indicate that authentication can be performed reliably in a laboratory or in the field utilizing easy to use portable devices, and proves that Applied DNA’s SigNature^® Molecular Tag can be safely introduced onto the surface of a capsule in ordinary pharmaceutical ink. The patent-pending, user-friendly method and system showed the molecular tag can be read at any time after simple, non-destructive swabbing.

“We believe DNA tagging of inks, coatings, and other ingredients can be used in the pharmaceutical supply chain, securing authenticity of an individual dose from the manufacturer, to the distributor, and finally the pharmacy. Authentication is possible, even when the product is separated from packaging, making it a solid complement to serialization and a platform to be considered as a weapon against today’s most difficult challenges, such as the opioid crisis,” said Dr. James Hayward, president and CEO, Applied DNA.

Drug overdose deaths in the United States are at unprecedented levels, with synthetic opioids increasingly implicated in overdoses, and the World Health Organization (WHO) estimates that 1-in-10 medical products circulating in low- and middle-income countries is either substandard or falsified.

“Counterfeit drugs represent a large and growing problem for the global pharmaceutical industry, and can lead to serious illness or death. Publication of our methods and systems for molecular tagging of pharmaceuticals is a seminal development in our industrial deployment, and acceptance of our methods by scientific peers is a welcome endorsement,” said Dr. Michael Hogan, vice president, Life Sciences, Applied DNA.

About PLOS ONE

The world’s first multidisciplinary Open Access journal, PLOS ONE accepts scientifically rigorous research, regardless of novelty. PLOS ONE’s broad scope provides a platform to publish primary research including interdisciplinary and replication studies as well as negative results. The journal’s publication criteria are based on high ethical standards and the rigor of the methodology and conclusions reported.

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

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Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation 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, uncertainties relating to its ability to maintain its NASDAQ listing, uncertainties relating to receiving regulatory clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies 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 18, 2018 and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019 and May 9, 2019, 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 to reflect the occurrence of unanticipated events, unless otherwise required by law.

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