With synthetic opioids lurking, DNA detector scores

Real deal: Applied DNA's field-tested, molecular-taggant supply chain authenticator is earning serious scientific cred in pharmaceutical circles.
By GREGORY ZELLER //

With synthetic opioids increasingly implicated in the alarming number of drug-overdose deaths plaguing the nation, a stalwart Long Island biotech’s DNA-based tracking technology has received a major endorsement.

The peer-reviewed scientific journal PLOS ONE has published a paper by Stony Brook-based Applied DNA Sciences on the molecular tagging of pharmaceuticals – a next-gen supply-chain authenticator that Applied DNA considers unforgeable, inescapable and particularly useful in a world where counterfeit drugs are routinely killing unsuspecting users.

In an experiment designed to test a proprietary method of distinguishing legitimate pharmaceuticals from counterfeit products, including imitation opioids, a pharma manufacturer tagged acetaminophen capsules with “pharmaceutical-grade ink” containing Applied DNA’s SigNature molecular tags.

The study not only proved that the DNA-based molecular tags could be safely introduced to ordinary pharmaceutical ink, but that authentication of the tags – via handheld portable devices – could be “performed reliably” in the field, according to “Rapid authentication of pharmaceuticals via DNA tagging and field detection,” published in PLOS ONE’s June 2019 edition.

James Hayward: Locked and loaded, safety on.

The publication sets a potentially major precedent for a pharmaceutical industry besieged by misuse, abuse and dangerous deception: A small DNA fragment could be introduced into virtually any pharmaceutical application, allowing easy supply-chain tracking of legitimate products via forensic authentication – and a surefire method for spotting frauds.

Earning space in the scientifically rigorous PLOS ONE, the world’s first multidisciplinary open-access journal, is a big win for the patented SigNature DNA tech and the patent-pending portable SigNature reader, according to Applied DNA Sciences President and CEO James Hayward, who trumpeted a new “weapon against today’s most difficult challenges, such as the opioid crisis.”

“We believe DNA tagging of inks, coatings and other excipients can … [secure] authenticity of an individual dose from the manufacturer, to the distributor and finally the pharmacy,” Hayward said. “Authentication is possible even when the product is separated from packaging, making it a solid complement to serialization.”

The novel physical-chemical identifier system approaches the limelight at a time when drug-overdose deaths in the United States are at unprecedented levels – the Mayo Clinic traces a 30-year buildup to today’s opioid crisis – and synthetic opioids, often sold to unwitting heroin addicts, are largely to blame.

Meanwhile, outside the States, the World Health Organization estimates that one in 10 medical products circulating in low- and middle-income countries is either substandard or straight-up fake.

These statistics make counterfeit pharmaceuticals an epidemic unto themselves, according to Michael Hogan, Applied DNA’s vice president for life sciences, who said with the PLOS ONE publication, the Stony Brook biotech is a big step closer to addressing this “large and growing problem” for the global pharmaceutical industry.

“Publication of our methods and systems for molecular tagging of pharmaceuticals is a seminal development in our industrial deployment,” Hogan added. “And acceptance of our methods by scientific peers is a welcome endorsement.”