PLOS ONE Publication Details Proprietary Method to Distinguish
Legitimate Pharmaceutical Drugs from Counterfeit Products Including
Counterfeit Opioids
Applied
DNA Sciences, Inc. (NASDAQ: APDN), announced today that its
scientific paper entitled, ‘Rapid
authentication of pharmaceuticals via DNA tagging and field detection’,
has been published in the June 2019 edition of PLOS ONE,
detailing a novel Physical-Chemical
Identifier (PCID) to authenticate and track legitimate
pharmaceutical products through the pharmaceutical supply chain.
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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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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