SAN DIEGO and MINEOLA, N.Y., Jan. 29 /PRNewswire-FirstCall/ -- Sequenom, Inc. and Lenetix Medical Screening Laboratory, Inc., a provider of rapid genetic screening and diagnostic testing for clinicians worldwide, today announced that they have entered into a collaboration and license agreement to develop and commercialize a proprietary non-invasive prenatal Rhesus D (RhD) incompatibility test based on Sequenom patent rights and RT PCR methodology. The RhD test, Sequenom's first non-invasive prenatal test, is expected to be marketed as a home brew test in the U.S. in the first half of 2007. Financial terms of the agreement were not disclosed.
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"The non-invasive characterization of fetal Rh genotype and other fetal genetic information has the potential to transform the practice of prenatal risk assessment," said Leonard Kellner, President of Lenetix. "This new approach to non-invasive evaluation of a baby in utero is a very exciting scientific and commercial development, and may significantly reduce the need for invasive fetal diagnostic tests such as amniocentesis or chorionic villus sampling."
RhD blood group incompatibility between a pregnant woman and her fetus is a significant health problem due to the possibility of maternal alloimmunization and consequent hemolytic disease of newborns. Although the pregnancy in which alloimmunization first occurs results in an unaffected child, future children are at substantial risk of anemia and, in the worst cases, fetal death. In the U.S. alone, RhD incompatibility occurs in more than 10% of all pregnancies, translating into more than 400,000 cases of RhD incompatibility annually.
"This collaboration marks a significant milestone in our strategy to commercialize non-invasive prenatal diagnostic tests and we believe Lenetix's quality reputation and established position in prenatal testing will provide a solid foundation for our market entry," said Harry Stylli, Ph.D., President and Chief Executive Officer of Sequenom. "We expect physician and patient adoption of the RhD test could pave the way for greater acceptance of our broader portfolio of non-invasive prenatal diagnostic tests in development."
About Lenetix
Founded in 2001, Mineola, N.Y.-based Lenetix is a privately owned provider of innovative technologies focused on diagnostic testing, including prenatal diagnostics, and risk assessment for genetic disease. Lenetix brings more than 27 years experience developing new and innovative tests that are used by clinicians worldwide. The scientific team at Lenetix is well known for its ability to commercialize new technologies. It is recognized for its translational clinical research and integration of high quality clinical laboratory genetics services within medical centers, universities, and the private sector.
About Sequenom
Sequenom is committed to providing the best genetic analysis products that translate genomic science into superior solutions for biomedical research, molecular medicine, agricultural applications, and non-invasive prenatal testing. The Company's proprietary MassARRAY(R) 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(R) and MassARRAY(R) are trademarks of SEQUENOM, Inc.
Except for the historical information contained in this press release, the matters set forth herein, including statements regarding the Company's expected development and commercialization of a proprietary prenatal Rhesus D incompatibility test under the agreement, expected marketing of the test as a home brew test in the U.S. in the first half of 2007, the potential of the non-invasive characterization of fetal Rh genotype and other fetal genetic information to transform the practice of prenatal risk assessment and the potential of the approach to significantly reduce the need for invasive fetal diagnostics tests such as amniocentesis or chorionic villus sampling, the Company's intentions to commercialize non-invasive prenatal diagnostic tests, Lenetix's ability to provide a solid foundation for the Company's market entry into prenatal testing, the Company's expectation that physician and patient adoption of the Rhesus D test could lead to greater acceptance of the Company's broader portfolio of non-invasive prenatal diagnostic tests, and Sequenom's plans to develop and commercialize prenatal genetic tests for use with its systems or other platforms are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, as amended. 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 reliance upon the efforts of Lenetix, new technology development, product development and commercialization, competition, government regulation, obtaining or maintaining regulatory approvals, market acceptance of the Rhesus D test, the Company's technologies, and other risks detailed from time to time in the Company's SEC filings, including the Company's Annual Report on Form 10-K for the year ended December 31, 2005, the Company's most recently filed quarterly report on Form 10-Q, and other documents subsequently filed with or furnished to the U.S. Securities and Exchange Commission (SEC). These forward-looking statements are based on current information that is likely to change. 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.
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20040415/SQNMLOGOAP Archive: http://photoarchive.ap.orgPRN Photo Desk, photodesk@prnewswire.comSequenom, Inc.; Lenetix Medical Screening Laboratory, Inc.CONTACT: John Sharp, Principal Financial Officer of Sequenom, Inc.,+1-858-202-9032; or Leonard Kellner, President of Lenetix, +1-516-248-0036;or Investor Relations, Zachary Bryant, zbryant@lhai.com, or Jody Cain,jcain@lhai.com, both of Lippert/Heilshorn & Associates, +1-310-691-7100,for Sequenom, Inc.
