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Last Updated: Oct 11, 2012 - 10:22:56 PM
27th Annual Meeting of the Society for Maternal-Fetal Medicine ; San Francisco Obstetrics Channel

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Non-invasive alternative to amniocentesis ?

Feb 11, 2007 - 4:20:07 AM , Reviewed by: Dr. Priya Saxena
"This is potentially one of the biggest steps forward to determine genetic conditions in the fetus. The ability to make an early diagnosis is the key that opens the door for the future treatment of many birth defects before the child is born."

 
[RxPG]
Non-invasive alternative to amniocentesis ?
Invasive techniques involve sampling amniotic fluid that surrounds the baby in the uterus or tissue sampling of the placenta.
Research studies demonstrating the viability of an approach to routinely detect the presence of fetal DNA in a mother's blood to accurately diagnose or rule out genetic defects -- as early as the first trimester -- was presented today at the 27th Annual Meeting of the Society for Maternal-Fetal Medicine being held in San Francisco. This future diagnostic technology, currently under development at Sequenom, Inc. (Nasdaq: SQNM), shows promise that a universal alternative to such invasive genetic screening procedures as amniocentesis and chorionic villus sampling, may be available in the future.

These implications are important to women with high-risk pregnancies, in that this future non-invasive screening technique will have significant benefit to all expectant mothers, especially on the heels of new guidelines endorsed by the American College of Obstetricians and Gynecologists (ACOG) that call for risk assessment of all pregnancies for fetal chromosomal abnormalities.

Previous guidelines recommended testing women 35 years and older using amniocentesis or chorionic villus sampling, both considered invasive procedures that carry risks. ACOG now recommends screening before the 20th week of pregnancy using a less invasive screening option that includes ultrasound in conjunction with the measurement of certain blood hormones.

Invasive techniques involve sampling amniotic fluid that surrounds the baby in the uterus or tissue sampling of the placenta. Sequenom's proprietary Fetal Nucleic Acid Technology, currently being developed, may be applicable to a range of non-invasive prenatal tests that use a mother's blood sample for fetal genetic screening. Sequenom's technology, based in part on the foundational research of Professors Dennis Lo and James Wainscoat while at the University of Oxford, isolates and analyzes circulating fetal nucleic acid from a maternal blood sample.

In the opinion of Dr. Kenneth Moise, Professor of Obstetrics and Gynecology and a specialist in Maternal-Fetal Medicine at Baylor College of Medicine in Houston, Texas, this is a major research breakthrough in prenatal medicine.

"This is potentially one of the biggest steps forward to determine genetic conditions in the fetus. The ability to make an early diagnosis is the key that opens the door for the future treatment of many birth defects before the child is born," says Dr. Moise. "This shows promise as an excellent alternative to amniocentesis and may give expectant parents peace of mind."

Through technology licensing agreements with clinical laboratories, Sequenom expects a non-invasive application of its technology for fetal Rhesus D (RhD) typing to become available in these laboratories beginning in the first half of 2007. Rhesus disease can occur when the blood of the expectant mother is incompatible with her unborn child. According to the Centers for Disease Control and Prevention (CDC), the incidence of hemolytic disease caused by RhD incompatibility in newborns occurs in approximately 1 in 1,000 live born infants. Complications from RhD disease can lead to jaundice, anemia, brain damage, heart failure, and death.

"We are making significant progress in developing our proprietary Fetal Nucleic Acid Technology and anticipate applying our novel approach to multiple prenatal tests such as tests for RhD, cystic fibrosis, Down syndrome, and others," said Dr. Harry Stylli, Sequenom President and Chief Executive Officer. "We believe our technology has great potential to substantially improve the standard of care for all pregnant mothers."



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 Additional information about the news article
About Sequenom

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. Except for the historical information contained in this press release, the matters set forth herein, including statements regarding Sequenom's approach for and the viability of prenatal genetic testing, future diagnostic technology, the potential for an alternative to amniocentesis, the promise of and future availability of a universal alternative to invasive genetic screening procedures such as amniocentesis and chorionic villus sampling, the implications or benefit and the significance of any benefit of a future non-invasive screening technique to all expectant mothers, the applicability of Sequenom's Fetal Nucleic Acid Technology to a range of non-invasive prenatal tests and anticipated application to multiple prenatal tests such as tests for cystic fibrosis, Down syndrome, and others, the potential of Sequenom's technology to substantially improve the standard of care for all pregnant mothers, Sequenom's expected availability of a non-invasive application of its technology for fetal RhD typing in laboratories in the first half of 2007, the potential of Sequenom's approach or its technology to be one of the biggest steps forward to determine genetic conditions in a fetus, the ability to make an early diagnosis and the future treatment of many birth defects before a child is born, and Sequenom's plans to develop and commercialize non-invasive prenatal genetic tests for use with the MassARRAY system and 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 other parties, new technology development, product development and commercialization, competition, government regulation, obtaining or maintaining regulatory approvals, market acceptance of new technology and products such as Sequenom's Fetal Nucleic Acid Technology, and other risks detailed from time to time in Sequenom's SEC filings, including Sequenom's Annual Report on Form 10-K for the year ended December 31, 2005, Sequenom'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.

CONTACTS:

Sequenom, Inc. Contact:
Steve Owings
Vice-President Commercial Development
(858) 202-9000

Media Contact:
David Schemelia
HealthSTAR Public Relations
646-722-8819 (dschemelia@healthstarpr.com)

Investor Relations Contact:
Zachary Bryant (zbryant@lhai.com)
Jody Cain (jcain@lhai.com)
Lippert/Heilshorn & Associates
(310) 691-7100

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