SOURCE: Applied DNA Sciences

Applied DNA Sciences

March 18, 2015 05:30 ET

Applied DNA Sciences Launches DNA Taggant and On-Site Authentication for Pharmaceutics

Multiple Trials Demonstrate That SigNature® DNA Inclusion in Drugs Provides Forensic Proof of Authenticity Seamlessly From Supply Chain to Consumer

STONY BROOK, NY--(Marketwired - March 18, 2015) - Applied DNA Sciences, Inc. (NASDAQ: APDN) (NASDAQ: APDNW) (Twitter: @APDN), a provider of DNA-based anti-counterfeiting technology, supply chain and product authentication solutions, today announced a landmark in the deployment of its SigNature® DNA technology as a physical or chemical drug formulation identifier (PCID) in the pharmaceutical industry. APDN has incorporated its SigNature DNA into ordinary pharmaceutical grade inks; successfully marked more than 10,000 prescription drugs, acetaminophen gel-tabs and aspirin tablets with the DNA-embedded ink; and shown that the DNA in those inks can be detected as a PCID and used for authentication via proprietary DNA amplification technologies.

Of greatest significance is that APDN has shown that the SigNature DNA printed upon standard pharmaceutical dosages is now forensically detectable in a field-deployable format. Using company-developed PCR (Polymerase Chain Reaction) and isothermal amplification methods, kits and devices, based on SigNature DNA, customers will be able to conduct on-the-spot field authentication of electronic devices, fibers such as wool and cotton, other high value commodities and now, for the first time, pharmaceutics.

The technology satisfies the principles established by FDA Guidelines for inclusion in pharmaceutics and is equally applicable to food and cosmetic products.

APDN is currently involved in a trial with one of the world's largest pharmaceutic companies. The trial is being conducted through one of APDN's channel partners.

SigNature DNA marks are always customer-specific, but may provide finer resolution as product-specific or even batch-specific markers. Encryption keys permit the inclusion of specific content in which the DNA sequence mimics binary code. The encrypted content serves the dual purposes of authentication and track-and-trace.

APDN can DNA-mark bulk Active Pharmaceutical Ingredient (API), often manufactured off-shore, enabling verification of its authenticity at any point in the supply chain. The company has also DNA-marked the cellulosic excipients (bulk fillers) that are used in almost all drug tablets and the commercial binders and enteric coatings that hold prescription and Over-the-Counter (OTC) drug tablets together.

Dr. James Hayward, CEO and President of APDN commented: "We believe that the ability to authenticate drugs as a field-deployed SigNature-DNA test may significantly benefit the pharmaceutical industry. We envision that the pairing of SigNature-DNA with fast, simple, low-cost DNA analysis tools at importation sites, with Customs and Border Patrol (CBP) or the Drug Enforcement Agency (DEA), at central distribution sites, or even at large pharmacies or clinics, will enable a completely new way to protect the pharmaceutical supply chain and provide confidence to consumers."

Dr. Mike Hogan, APDN's VP of Life Sciences said: "These NexGen PCR methods would also permit law enforcement agencies to track the movement of illicit drugs, and conduct safe sting operations."

It is extremely difficult to precisely estimate the prevalence of economic impact of counterfeit drugs since most counterfeit transactions take place sub rosa. The World Health Organization (WHO) has estimated that globally, up to 10% of prescription drugs are counterfeit, while multiple sources estimate that global sales of counterfeit drugs exceed $200 billion annually (http://www.reuters.com/article/2010/06/10/us-customs-drugs-idUSTRE65961U20100610).

With its field reading technology now in hand, APDN delivers a completely new set of tools to protect the safety and efficacy of global pharmaceutics, foods and cosmetics.

About Applied DNA Sciences

We make life real and safe by providing botanical-DNA based security and authentication 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. SigNature® DNA describes the platform ingredient that is at the heart of all of our security and authentication solutions. SigNature DNA is at the core of a family of uncopyable products such as DNAnet®, our anti-theft product, SigNature® T, targeted toward textiles, and digitalDNA®, providing powerful track and trace. All provide a forensic chain of evidence and can be used to prosecute perpetrators.

Applied DNA Sciences common stock is listed on NASDAQ under the symbol APDN, and its warrants are listed under the symbol APDNW. 

Forward-Looking Statement
The statements made by APDN 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 APDN'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 APDN. Actual results could differ materially from those projected due to our short operating history, limited financial resources, limited market acceptance, market competition and various other factors detailed from time to time in APDN's SEC reports and filings, including our Annual Report on Form 10-K filed on December 15, 2014, and our subsequent quarterly report on Form 10-Q which are available at www.sec.gov. APDN 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.

Contact Information