SAN DIEGO--(BUSINESS WIRE)--Sequenom, Inc. (Nasdaq: SQNM - News) today announced that it has secured exclusive rights to fundamental patent rights for digital PCR technologies and methods through a licensing agreement with Genomic Nanosystems, LLC, a wholly owned subsidiary of the Cytonix Corporation. The exclusively licensed rights include United States Patent Nos. 6,143,496 and 6,391,559 and pending applications. The license provides Sequenom with the exclusive right to use digital PCR methods on any platform for noninvasive prenatal diagnostics and analysis for any sample (for example, fetal cells, amniocentesis fluids, plasma, urine, etc.). Sequenom also secured the exclusive right to use digital PCR methods in conjunction with mass spectrometry for any commercial, diagnostic or research purpose, excluding second generation sequencing. Financial terms were not disclosed.
“Sequenom’s extensive intellectual property position in noninvasive prenatal diagnostic testing for the assessment of fetal Down syndrome and other fetal genetic conditions is enhanced by this partnership, enabling us to develop even more highly sensitive tests on our MassARRAY® system, as well as other platforms of our choice in our fields of use,” said Harry Stylli, Ph.D., President and Chief Executive Officer of Sequenom. “We are particularly pleased to be chosen as an exclusive partner by Genomic Nanosystems. These exclusive rights, as well as the licensing agreement we announced last week, further strengthen the proprietary foundation upon which we will continue product development and commercialization in our SEQureDx™ diagnostics business. Furthermore, Sequenom intends to develop a MassARRAY platform-based digital PCR solution for our genomic analysis business and for cancer research and diagnostics.”
Luke Ranasinghe, Ph.D., Chief Technical Officer of Genomic Nanosystems, added, “Digital PCR and Genomic Nanosystems’ portfolio of digital amplification methods provide for detection and quantification of rare and/or foreign genetic sequences. We are pleased to license these patents to Sequenom whose capabilities and innovation provide unprecedented opportunities for molecular genetic analysis in prenatal diagnostics, as well as cancer and infectious disease.”
Conventional PCR methods have inherent inaccuracies, are unable to provide information about single molecules, and have limited dynamic range. Digital PCR, in contrast, comprises methods for amplifying and detecting individual nucleic acid molecules, leading to “needle in the haystack” detection capability with nearly unlimited dynamic range. Chromosomal counting is just one example of how digital PCR can be applied. Therefore, Digital PCR in combination with Sequenom’s technology has the potential to enable the detection of prenatal genetic characteristics soon after conception, and early detection of cancer derived nucleic acids, in some cases months earlier than other diagnostic methods.
Sequenom’s Proprietary Noninvasive Prenatal Diagnostics
Sequenom’s commercial opportunities in prenatal diagnostics are built upon its SEQureDx technology and are enabled by the pioneering inventions and associated intellectual property rights that it has exclusively licensed from Isis Innovation Ltd., the technology transfer company of the University of Oxford, as well as The Chinese University of Hong Kong. Sequenom’s portfolio of noninvasive prenatal diagnostic patent rights and patent applications is platform-independent, includes genetic-analysis methods using circulating cell-free fetal nucleic acids from maternal samples, and also includes a portfolio of methylation and nucleic-acid markers. Sequenom is actively expanding its intellectual property position with new technology and new territories. Because Sequenom’s license rights are platform-independent, the rights provide exclusivity (with the narrow exception in Europe for RT-PCR-based Rhesus D tests) for development and commercialization of noninvasive prenatal tests on any platform and are not limited to the Company’s MassARRAY platform.
About Sequenom
Sequenom is committed to providing the best genetic analysis products that translate the results of genomic science into solutions for noninvasive prenatal diagnostics, biomedical research, translational research and molecular medicine applications, and for research conducted in the agro (agricultural and livestock) industry. The Company’s proprietary MassARRAY system is a high-performance (in speed, accuracy and cost efficiency) DNA analysis platform that quantitatively and precisely measures genetic target material and variations. The Company has exclusively licensed intellectual property rights for the development and commercialization of non-invasive prenatal genetic tests for use with the MassARRAY system and other platforms.
Sequenom®, SEQureDxTM, and MassARRAY® are trademarks of Sequenom, Inc.
Genomic Nanosystems Proprietary Digital PCR Technology
Digital PCR and related single molecule assays were developed by Cytonix Corporation and the National Institutes of Health in 1995. Exclusive rights to the almost 2000 issued and pending patent claims that resulted from this work were licensed to Genomic Nanosystems in December 2006.
About Genomic Nanosystems, LLC
Genomic Nanosystems, LLC (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 GNS’s related portfolio of intellectual property. Since 2006, GNS has developed self-assembling digital arrays, digital emulsion materials, devices and methods, and generated hundreds of inventions claimed in pending and issued patents. Drawing on other Cytonix intellectual property, nanofluidic and electrokinetic 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 registered trademark of Genomic Nanosystems, LLC.
Sequenom Safe Harbor
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company’s product development and commercialization in its SEQureDx diagnostics business, the Company’s intentions to develop a MassARRAY platform based digital PCR solution for its genomic analysis business and for cancer research and diagnostics, the capabilities and potential enablement by combining Digital PCR with the Company’s technology, and the Company’s opportunities in prenatal diagnostics, cancer, and infectious disease, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with demand for and market acceptance of the Company’s products, services, and technologies, new technology and product development and commercialization particularly for new technologies such as molecular and noninvasive prenatal diagnostics and digital PCR, reliance upon the collaborative efforts of other parties, competition, government regulation, obtaining or maintaining regulatory approvals, and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission. These forward-looking statements are based on current information that is likely to change and speak only as of the date hereof. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and Sequenom undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
Contact:
Company Contact Sequenom, Inc. Paul W. Hawran, Chief Financial Officer 858-202-9000 or Investor Relations Contact Lippert/Heilshorn & Associates Jody Cain, jcain@lhai.com Kevin Mc Cabe, kmccabe@lhai.com 310-691-7100
Source: Sequenom, Inc.
