Sequenom To Begin Clinical Assessment Of Noninvasive Screening Technology For Down Syndrome

Main Category: Genetics
Also Included In: Pediatrics / Children's Health;  Pregnancy / Obstetrics
Article Date: 24 Jan 2008 - 2:00 PDT

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Sequenom, Inc. (NASDAQ:SQNM) announced the approval of a protocol by the Institutional Review Board (IRB) at San Diego-based Sharp HealthCare, clearing the way to commence patient enrollment in a screening study to clinically assess the Company's noninvasive cell free fetal nucleic acid SEQureDx™ Technology for the detection of fetal aneuploidy, including Down syndrome, using a laboratory developed test (LDT).

More than 2.7 million pregnancies are evaluated annually in the United States to assess the risk of Down syndrome by various screening methods, which are comprised of surrogate serum markers in combination with ultra-sonographic methods. These risk assessment protocols result in the referral of approximately 5% of normal pregnancies to be screened through invasive procedures, such as amniocentesis, to help rule out the chances of an affected pregnancy for Down syndrome. Sequenom's SEQureDx Technology, to be evaluated in this screening study, provides a direct genetic assessment of Down syndrome using a noninvasive maternal blood sample collected in the first or second trimester of pregnancy. The expected benefits of this approach are to improve current detection rates, while reducing the number of patient referrals (false positives) to the invasive procedures and fetal losses due to the procedures, which are currently employed in prenatal screening programs throughout the U.S.

"This clinical assessment represents an important milestone in our prenatal genetic testing development program and keeps us on track with our plan to introduce an LDT for Down syndrome in late 2009," said Harry Stylli, Ph.D., Sequenom's President and Chief Executive Officer. "Our SEQureDx Technology-based noninvasive screening method, if verified, could revolutionize Down syndrome prenatal screening."

"Sequenom's technology for Down syndrome screening offers great promise for how we manage our obstetric population within the Sharp HealthCare system and the nation. It will greatly improve the quality of prenatal screening and, ultimately, will reduce the need for invasive prenatal diagnosis - a significant source of anxiety for pregnant women," said Allan Bombard, MD, a reproductive geneticist with more than two decades of experience in the field of prenatal diagnosis, who serves as a Medical Director at Sharp and is the principal investigator of the study.

In 2007, the American College of Obstetricians and Gynecologists (ACOG) endorsed guidelines that call for risk assessment of all pregnancies for fetal chromosomal abnormalities, including Down syndrome. The ACOG recommendation includes 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.

About Fetal Nucleic Acid Technology

Sequenom's SEQureDx Technology is a novel approach to genetic screening. Unlike current standards of harvesting placental tissue cells as is required for chorionic villus, or entering the uterus to sample the amniotic fluid surrounding the baby as is performed with amniocentesis, SEQureDx Technology extracts Fetal Nucleic Acid material safely and comfortably from a simple blood specimen collected from the mother to determine the genetic status of the fetus. This breakthrough suggests that effective screening may be accomplished in the future without the risks associated with disturbing the amniotic fluid that surrounds the baby in the uterus.

About Sharp HealthCare

A 2007 Malcolm Baldridge National Quality Award Recipient, Sharp HealthCare is San Diego's most comprehensive health care delivery system. It is recognized for clinical excellence for services in cardiac, cancer, and multiorgan transplantation, as well as orthopedics, rehabilitation, behavioral health, and women's health. The Sharp system includes four acute-care hospitals, three specialty hospitals, three affiliated medical groups, and a health plan. To learn more about Sharp, visit http://www.Sharp.com.

About Sequenom

Sequenom is committed to providing the best genomic and genetic analysis products for research and the molecular diagnostic markets. The Company makes available superior solutions for genomic science in biomedical research, livestock and agricultural applications and molecular medicine, as well as for various diagnostic markets, including noninvasive prenatal testing, oncology and infectious diseases. Sequenom's proprietary MassARRAY® system delivers reliable and specific data from complex biological samples and from genetic target materials available only in trace amounts.

Sequenom®, SEQureDxTM, 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 commencement of and patient enrollment in a screening study to clinically assess the Company's SEQureDx Technology for the detection of fetal aneuploidy including Down syndrome, the expected benefits of SEQureDx Technology, the Company's plan to introduce a test for Down syndrome in late 2009, the results, outcome, or future impact of the study on Down syndrome prenatal screening, and the future impact of SEQureDx Technology on healthcare, 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 new technology and product research, development and commercialization particularly for new screening and molecular diagnostic technologies such as the Company's SEQureDx Technology, demand for and market acceptance of the Company's products, services, and technologies, reliance upon the collaborative efforts of other parties, research and development progress, competition, government regulation, obtaining or maintaining regulatory approvals, and other risks detailed from time to time in the Company's SEC (U.S. Securities and Exchange Commission) filings, including the Company's Annual Report on Form 10-K for the year ended December 31, 2006 and other documents subsequently filed with or furnished to the SEC. These forward-looking statements are based on current information that may change and 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 the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

http://www.sequenom.com