Applied DNA Files Provisional Patent Application for
High Sensitivity COVID-19 Diagnostic Assay with
U.S. Patent and Trademark Office
STONY BROOK, N.Y., - March 24, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development, and diagnostics, announced today the filing of a provisional patent application with the United States Patent and Trademark Office (USPTO) for its diagnostic assay under development for SARS-CoV-2, the virus that causes the disease COVID-19. The application follows the Company’s announcement on March 19, 2020 that it had completed the design of its COVID-19 detection assay.
“This provisional patent application is a necessary and important step to protect our intellectual property that underpins our detection assay. With the U.S. Federal Drug Administration having recently issued guidance that allows companies to manufacture and ship COVID-19 tests under the Agency’s Emergency Use Authorizations, we are in the process of manufacturing kits for validation at hospitals both in New York State and Italy,” stated said Dr. James Hayward, president and CEO of Applied DNA. “This application is also reflective of our expanding nucleic acid-based therapeutic and diagnostic patent estate. With the addition of this provisional patent application, Applied DNA has over 15 pending and issued patents aimed at nucleic acid-based therapeutics and diagnostics, including certain U.S. and PCT (international) patent applications pertaining to the use of PCR-produced LinearDNA™ amplicons as DNA vaccines that, if granted, we believe, would encompass our linear DNA-based COVID-19 vaccines candidates currently being co-developed with Takis Biotech.”
Applied DNA makes clear that no commercial partner has been identified to take the developmental diagnostic to market nor is there any indication that the Company’s diagnostics would be approved by the U.S. Federal Drug Administration and other regulators.
About Applied DNA Sciences, Inc.
Applied DNA is a provider of nucleic acid technologies that enable diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting anti-theft technology and product genotyping.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc
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 the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration 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 to U.S. FDA or equivalent foreign regulatory agencies, Applied DNA’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; 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 12, 2019 and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, 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.
investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, firstname.lastname@example.org
program contact: Brian Viscount, Applied DNA, 631-240-8877, email@example.com