Applied DNA Files Provisional Patent Application for High Sensitivity COVID-19 Diagnostic Assay with U.S. Patent & Trademark ...
March 24 2020 - 7:00AM
Business Wire
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.
Visit adnas.com for more information. Follow us on Twitter and
LinkedIn. Join our mailing list. Common stock listed on NASDAQ
under the symbol APDN.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc
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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200324005127/en/
investor contact: Sanjay M. Hurry, LHA Investor
Relations, 212-838-3777, shurry@lhai.com program contact:
Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com
web: www.adnas.com, www.adnas.com/linearx twitter:
@APDN
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