Using SigNature DNA to Prevent Counterfeiting and Product Diversion

Abstract
Applied DNA Sciences (APDN) provides botanical DNA encryption, embedment and authentication solutions that can help protect companies, governments and consumers from counterfeiting, fraud, piracy, product diversion, identity theft and unauthorized intrusion into physical locations and databases. Our SigNature™ Program provides a secure, accurate and cost-effective means for our potential customers to incorporate our SigNature™ DNA Markers in, and then quickly and reliably authenticate and identify a broad range of items including art and collectibles, fine wine, consumer products, pharmaceuticals, digital media, financial instruments, identity cards and other official documents. Having the ability to reliably authenticate and identify counterfeit versions of such items enables companies and governments to detect, deter, interdict and prosecute counterfeiting enterprises and individuals.

Introduction
Counterfeiting, product diversion, piracy, forgery, identity theft, and unauthorized intrusion into physical locations and databases create significant and growing problems to companies in a wide range of industries as well as governments and individuals worldwide. The U.S. Chamber of Commerce reported in 2006 that counterfeiting and piracy cost the U.S. economy between $200 and $250 billion per year, was responsible for the loss of 750,000 American jobs and increasingly poses a real threat to consumer health and safety. The World Customs Organization and Interpol estimate that annual global trade in illegitimate goods was roughly $600 billion in 2004. Overall it is estimated that between 5-10% of global trade is affected by counterfeiting and diversion, equal to hundreds of billions of dollars annually.

Historically, counterfeiting, product diversion and other types of fraud have been combated by embedding various authentication systems and rare and easily distinguishable materials into products, such as radio frequency identification (RFID) devices and banknote thread in packaging, integrated circuit chips and magnetic strips in automatic teller machine cards, holograms on currency, elemental taggants in explosives and radioactivity and rare molecules in crude oil. These techniques are effective but have generally been reverse engineered and replicated by counterfeiters, which limits their usefulness as forensic methods for authentication of the source of products and other items. SigNature™ DNA Markers are as broadly applicable, convenient and inexpensive as existing authentication systems, while being highly resistant to reverse engineering or replication. Either applied independently or to supplement existing systems, SigNature™ DNA Markers offer a forensic level of authentication for a broad range of items providing an additional deterrent in the constant battle against counterfeiting and piracy.

DNA Markers
Every living organism has a unique DNA code that determines the character and composition of its cells. Botanical DNA encryption, embedment and authentication solutions can help protect companies, governments and consumers from counterfeiting, fraud, piracy, product diversion, identity theft and unauthorized intrusion into physical locations and databases. The core technologies of Applied DNA Sciences business allow us to use the DNA of everyday plants to mark objects in a unique manner that can only be replicated at great expense, and then identify these objects by detecting the absence or presence of the DNA.

The proprietary program consists of three steps – creating and encapsulating a specific encrypted DNA segment, applying it to a product or other item and detecting the presence or absence of the specific segment.

Creating and Encapsulating DNA
The SigNature™ DNA Markers are botanical DNA segments custom manufactured to identify a particular class of or individual product or item. During the manufacturing process, the naturally occurring botanical DNA segment or segments are taken and rearranged into unique encrypted segments or chimers whose sequences are known only to APDN. These sequences are then recorded and stored in a secure database. The DNA is modified, not for its biological relevance, but for its information content and is rendered biologically non-functional during this process. Because DNA is inherently unique and dense with information, only minute amounts of DNA molecules need to be placed on any product to mark and authenticate it.

A proprietary encapsulation system allows for the application of a protective coating to encrypt DNA chimers, creating SigNature™ DNA Markers that are resistant to heat, organic solvents, chemicals and UV radiation and so can be identified for hundreds of years after being embedded directly or into media applied or attached to the item to be marked.

Embedding DNA
A patented embedment system allows the incorporation of SigNature™ DNA Markers into a broad variety of things. APDN SigNature™ DNA Markers can be directly embedded in products or other items, or otherwise attached by embedding them into media (such as ink, varnish, paint and thread) that is incorporated in or attached to the product or item. SigNature™ DNA Markers can be embedded directly in paper, metal, plastics, stone, ceramic and other materials. SigNature™ DNA Markers can also be embedded onto printed barcodes, RFID tags, optical memory strips, holograms, tamper proof labels and other security devices incorporated into products and other items for various security-related purposes.

SigNature™ DNA Markers can be readily incorporated into inks and coatings which can then be applied directly or on a label that is then affixed to the product or item. SigNature™ DNA Ink is highly durable and degradation resistant. It can be visible (overt) or invisible (covert). Similar media like varnish and paints can also be used. SigNature™ DNA Markers can also be readily incorporated into thread, which can consist of any fabric from cotton to wool and can be used to mark and authenticate products and other items incorporating textiles.

Detecting the Presence or Absence of DNA Markers
Because the portion of DNA in a SigNature™ DNA Marker used to identify the marker is so minute, it cannot be detected unless it is replicated billions of times over, or amplified. This amplification can only be achieved by applying matching strands of DNA, or a primer and PCR techniques to the SigNature™ DNA Marker. The sequence of relevant DNA in a SigNature™ DNA Marker must be known in order to manufacture the primer for that DNA. As a result, the effort required to find, amplify, select and clone the relevant DNA in a SigNature™ DNA Marker would involve such enormous effort and expense that SigNature™ DNA Markers are virtually impossible to copy without APDN’s proprietary systems.

SigNature™ DNA Encryption Detector pens are custom manufactured to identify SigNature™ DNA Markers, allowing the determination of the presence or absence of these SigNature™ DNA Markers in around one second. When the SigNature™ DNA Encryption Detector Pen comes in contact with the proprietary overt ink on a label or product package, a biochemical reaction triggers a reversible color change from blue to pink and back to blue. Testing of this color change can be repeated between 30 to 50 times.

Recently, APDN has filed patent applications for the use of up-converting phosphors as an additional rapid detection platform. Addition of up-converting phosphors to inkjet ink affords the ability to quickly screen packages for the presence of a DNA marker, as SigNature DNA is covalently linked to the up-converting phosphor. Using an up-converting phosphor detector, the presence or absence of SigNature DNA can be rapidly detected in the field.

For forensic level authentication, APDN is working to provide a remote, portable, fast acting pcr machine able to authenticate products in the field in minutes. This hand held pcr device will provide quick end-point analysis, enabling users to operate the system with minimal training.

Proprietary PCR kits allow a sample to be taken from the product or other item to be authenticated and using proprietary primers and PCR technology, determine the sequences of DNA included in the sample and conclude whether it includes a specific SigNature™ DNA Marker. This authentication process provides absolute certainty about the presence or absence of specific types of SigNature™ DNA Markers, resulting in a forensic level of authentication which cannot be found with many other systems.

Conclusion
Applied DNA Sciences, SigNature™ DNA Markers offer a secure, accurate and cost-effective means of protecting a broad range of products from counterfeiting and piracy. It offers a forensic level of authentication and can be applied to a variety of media and materials either alone or to supplement existing systems. Having the ability to reliably authenticate and identify counterfeit versions of a broad range of items enables companies and governments to detect, deter, interdict and prosecute counterfeiting enterprises and individuals, offers customers and consumers assurance that the products are authentic and adds value to the bottom line by helping to diminish product diversion and counterfeiting. Preventing counterfeiting and piracy protects consumers, increases brand loyalty and reduces revenue losses to theft.