Healthcare Industry News: Fragile X
News Release - October 25, 2006
Sequenom Expands Non-Invasive Prenatal Diagnostic Testing OpportunityAcquires Rights to Gender Testing Intellectual Property
SAN DIEGO, Oct. 25 (HSMN NewsFeed) -- SEQUENOM, Inc. (Nasdaq: SQNM ) today announced that it has secured exclusive rights in the United States, Europe, Japan, Canada, and Australia to intellectual property for non-invasive prenatal gender testing through a licensing agreement with Isis Innovation Ltd., the technology transfer company of the University of Oxford. These intellectual property rights expand the scope of an earlier licensing agreement between Sequenom and Isis Innovation Ltd. announced in October 2005, under which Sequenom exclusively licensed intellectual property rights for non-invasive prenatal genetic diagnostic testing on fetal nucleic acids derived from maternal plasma or serum.
"Compared to other methods to determine gender, which include chorionic villus sampling, ultrasound, and amniocentesis, we expect our test will be more accurate and safer, and administered earlier in the pregnancy," said Betty Dragon, Ph.D., Senior Vice-President of Research and Development. "Gender determination also has clinical relevance in prenatal diagnosis of certain X-linked diseases such as hemophilia, Fragile X and congenital adrenal hyperplasia. The ability to accurately determine gender early in a pregnancy provides important information to both families and physicians and these newly secured rights strengthen our proprietary position with respect to the non-invasive prenatal testing portfolio we are developing."
About SEQUENOM's Prenatal Initiatives
Sequenom's opportunity in prenatal diagnostics builds on its core technology for the genetic analysis research market and is greatly strengthened by the broad intellectual property it has exclusively licensed. Sequenom has identified considerable unmet needs for new approaches that enable non-invasive and reliable prenatal diagnostic testing for expectant mothers and is pursuing development of a portfolio of non-invasive prenatal tests based on the analysis of circulating fetal nucleic acid in pregnant women obtained from a simple blood draw from the mother. By directly testing fetal DNA, the Company may provide more fundamental and reliable diagnostic information earlier in the pregnancy.
The licensed rights enable the development and performance of tests on any relevant platform, including the Sequenom MassARRAY® system, which is highly enabling for certain prenatal tests. Sequenom plans to introduce research-use only testing for fetal Rhesus D (RhD) in the first half of 2007. According to the Center for Disease Control, approximately 20,000 high risk RhD births occur out of 420,000 RhD incompatible pregnancies in the United States annually. In addition, Sequenom is establishing the advanced pre-analytics necessary to conduct the more technically challenging tests needed for cystic fibrosis, aneuploidies and others.
In molecular diagnostics, Sequenom's focus is prenatal diagnostics and other applications where complex, trace nucleic acid analysis will prove critical, primarily in women's health. Sequenom's MassARRAY platform has demonstrated utility for a wide range of nucleic acid tests and is not limited to prenatal testing.
About Isis Innovation Ltd.
Isis Innovation Ltd. is the technology transfer company of the University of Oxford, commercializing the research generated by University researchers and owned by the University. Isis was established in 1988 and in 1997 started a major expansion phase; Isis is a wholly owned subsidiary of the University of Oxford. The University assigns its intellectual property to Isis (where there are no pre-existing exploitation arrangements) and Isis then evaluates, protects and markets the intellectual property. For more information, visit www.isis-innovation.com.
Sequenom is committed to providing the best genetic analysis products that translate genomic science into superior solutions for biomedical research, agricultural applications, molecular medicine, and non-invasive prenatal testing. The Company's proprietary MassARRAY system is a high-performance DNA analysis platform that efficiently and precisely measures the amount of genetic target material and variations therein. The system is able to deliver reliable and specific data from complex biological samples and from genetic target material that is only available in trace amounts. 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® and MassARRAY® are trademarks of SEQUENOM, Inc.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company's non-invasive prenatal diagnostic gender testing opportunity, the significant potential of such opportunity, the Company's plans to commercialize the opportunity and expectation to offer a test that is more accurate, safer, and administered earlier in the pregnancy compared to other methods, and the Company's plans to introduce research-use only testing for fetal Rhesus D in the first half of 2007, 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 the Company's technologies, research and development efforts, governmental and other regulatory approvals, product development and commercialization, market acceptance of and demand for the Company's products, reliance upon the collaborative efforts of others, and other risks detailed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the year ended December 31, 2005 and subsequent periodic reports. 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.
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