Genomic Nanosystems Announces Exclusive Licensing Agreement to Sequenom for the Right to Use Digital PCR in Prenatal Testing and Mass Spectrometry

Beltsville, MD, September 22, 2008 --(PR.com)-- Genomic Nanosystems, LLC, today announced that it has granted an exclusive license to Sequenom, Inc. (Nasdaq: SQNM) for the right to use Digital PCR in noninvasive prenatal research and diagnostics on a technology, platform and sample independent basis, and has granted the exclusive right to use digital PCR in conjunction with mass spectrometry for any diagnostic or research purpose, excluding second generation genetic sequencing. Financial terms were not disclosed.

As explained by Elaine Lanza, Ph.D., Genomic Nanosystems (GNS) Managing Partner, “This license is essential in enabling Sequenom to use digital PCR with their extensive IP in the fields of prenatal testing and genetic analysis by mass spectrometry. GNS owns the central, core rights to digital PCR methods, and using this IP will provide Sequenom with a strong position in developing their genetic analysis and SEQureDX™ diagnostics businesses.”

Genomic Nanosystems Digital PCR Technology.
The methods for single molecule and nanoscale nucleic acid assays and the term and trademark DigitalPCR™ were developed and established by Cytonix in collaboration with the National Institutes of Health in 1995. The broad first U.S. Patent issued in 1997 (Patent No. 6,143,496) and the subsequently issued and pending divisional and continuation claims were exclusively licensed to Genomic Nanosystems in December 2006. Worldwide, there are now hundreds of publications on digital PCR, and numerous patent applications related to the domain of digital PCR.

Digital PCR is about isolating, amplifying and detecting individual nucleic acids molecules, such as DNA and RNA, in a large plurality of nanoscale volumes or surface regions, where amplified product from each zone remains localized, producing a detectable concentration. As examples: microfluidic devices may carry out digital PCR in thousands of nano-sized chambers; emulsions may have millions of micelles, each acting as a miniature reaction chamber; and for nucleic acids spotted on a surface, each site becomes a discrete region of digital amplification. Unlike conventional PCR methods, such as rtPCR, the amplification efficiency need not be considered, as only “yes or no” answers are required. Furthermore, the detection method is technology independent, meaning that fluorescence, chemoluminescence, mass spectrometry or any means can be used.

Digital PCR provides “needle in the haystack” detection capability, exquisite accuracy, and almost unlimited dynamic range. In practical terms, digital PCR can detect foreign DNA, cancer cells, pathogens or rare genetic events in a patient at far earlier stages than any other technology. In combination with Sequenom’s technology, digital PCR potentially offers detection of prenatal genetic characteristics, such as Down’s Syndrome, soon after conception, potentially months earlier than other diagnostic methods.

About Genomic Nanosystems
Genomic Nanosystems (GNS) is a Digital PCR company, holding intellectual property that is central and enabling to almost every frontier of life science and medicine. GNS was founded in 2006 as a wholly owned subsidiary of the Cytonix Corporation to develop technology, manufacture products, and provide licenses for digital PCR and related IP. Since 2006, GNS has developed self-assembling digital arrays, digital emulsion materials, devices and methods, and generated hundreds of inventions set forth in issued and pending patent claims. Drawing on other Cytonix IP, nanofluidic and electrowetting concepts are being applied to carry out complex digital PCR assays. Collaborations have lead to high-resolution detection systems for Digital PCR, and licensing efforts have resulted in a potentially robust network of business partnerships.

DigitalPCR™ is a trademark of Genomic Nanosystems, LLC. SEQureDX™ is a trademark of Sequenom, Inc.

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