Sequenom Announces Launch of SensiGene Fetal(XY) (Fetal Sex Determination) Test

SAN DIEGO, Feb. 16 /PRNewswire-FirstCall/ -- Sequenom, Inc. (Nasdaq: SQNM) today announced the launch of the SensiGene™ Fetal(XY) (Fetal Sex Determination) test by Sequenom's CAP accredited and CLIA-certified laboratory, Sequenom Center for Molecular Medicine (Sequenom CMM). This is the company's second laboratory developed test powered by its SEQureDx™ technology.

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The benefits of the SensiGene Fetal(XY) Fetal Sex Determination test include:

• Noninvasive and safe. The test requires only a simple blood sample from the mother.
• Early detection – first trimester fetal sex determination.
• Highly specific – allows the distinction between maternal and fetal DNA for both male and female fetuses.
• Physician-ordered.

"The launch of the SensiGene Fetal(XY) test represents another successful noninvasive prenatal test demonstrating the utility of using maternal blood to determine fetal status," said Lee P. Shulman, MD, Professor of Obstetrics and Gynecology and Chief of the Division of Clinical Genetics at the Feinberg School of Medicine at Northwestern University. "This is a great leap forward in delivering a test with a high degree of accuracy, using cutting-edge technology which has been rigorously evaluated through blinded studies, performed in collaboration with internationally recognized prenatal diagnosticians. This test adds to the physicians' prenatal diagnostic arsenal by providing for safe and accurate noninvasive fetal testing."

"I am very excited about the launch of the SensiGene Fetal(XY) test," added Shawn M. Marcell, vice president, molecular diagnostics. "Being able to offer physicians an advanced molecular diagnostic test with excellent performance is an important step in helping their patients focus on the positive nature of their pregnancy. Offering this test through a physicians' office should give mothers confidence in the test and assist doctors in the care of their patients."

About the SensiGene Fetal(XY) (Fetal Sex Determination) Test

The new SensiGene Fetal(XY) test is designed to detect circulating cell-free fetal (ccff) DNA in maternal blood. The test interrogates male specific targets on the Y chromosome. In addition to quality control metrics to ensure accuracy it also incorporates a fetal identifier control to facilitate the distinction between maternal and female fetal DNA. The test is performed using Sequenom’s proprietary MassARRAY® system, which allows direct mass measurement of nucleic acids.

As with the recently launched SensiGene Fetal RHD Genotyping test, more than 500 clinical samples were tested during the course of feasibility, optimization, verification and validation. The final blinded validation study, in which over 200 samples were evaluated, was performed in conjunction with the Fetal Medicine Foundation, and un-blinding was performed by Dr. Arnold Cohen, chairman of obstetrics and gynecology at the Albert Einstein Medical Center, in Philadelphia. In this validation study the SensiGene Fetal Sex Determination test demonstrated:

• Sensitivity of 97.9% (92.5% – 99.4% at a 95% confidence interval).
• Specificity of 100% (96.9% – 100% at a 95% confidence interval).

More information on the SensiGene test and fetal sex determination can be found at http://www.scmmlab.com/Home/Health-Care-Professionals/Fetal-Sex-Determination.

Sequenom supports the ACOG Committee Opinion, No. 360. Obstet Gynecol 109: 475-478.

About MassARRAY Technology

Sequenom's proprietary MassARRAY® system is a high performance matrix assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry-based nucleic acid analysis platform that quantitatively measures genetic target material and its variations in a rapid, accurate, and cost efficient manner. Sequenom's MassARRAY system facilitates a number of nucleic acid analysis applications including SNP genotyping and allelotyping, CNV analysis, quantitative gene expression analysis, quantitative methylation marker analysis, comparative sequence analysis of haploid organisms, SNP discovery, and oligonucleotide quality control.

About Sequenom Center for Molecular Medicine

Sequenom Center for Molecular Medicine® (Sequenom CMM), a CAP accredited and CLIA-certified molecular diagnostics laboratory, is developing a full range of advanced prenatal diagnostics. Branded under the name SensiGene™, these genetic tests provide earlier patient management alternatives for obstetricians, geneticists and maternal fetal medicine specialists. Sequenom CMM is changing the landscape in genetic disorder diagnostics using proprietary cutting edge technologies. Visit http://www.scmmlab.com for more information on laboratory services.

About Sequenom

Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery & clinical research, and molecular diagnostics markets. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.

Sequenom®, Sequenom® Center for Molecular Medicine®, SEQureDx™, SensiGene™, and MassARRAY® are trademarks of Sequenom, Inc. All other trademarks and service marks are the property of their respective owners.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the anticipated performance and benefits of the SensiGene Fetal(XY) sex determination test and its acceptance and use by physicians, and development of a full range of advanced prenatal diagnostics by Sequenom CMM, 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 market demand for and acceptance and use by customers of new laboratory developed tests such as the SensiGene Fetal(XY)  sex determination test, ongoing litigation and investigations involving the Company, the Company's financial position, its ability to position itself for product launches and growth and develop and commercialize new technologies and products, particularly new technologies such as noninvasive prenatal diagnostics, laboratory developed tests, and genetic analysis platforms, reliance upon the collaborative efforts of other parties, the Company's ability to manage its existing cash resources or raise additional cash resources, competition, intellectual property protection and intellectual property rights of others, government regulation particularly with respect to diagnostic products and laboratory developed tests, obtaining or maintaining regulatory approvals, and other risks detailed from time to time in the Company's Annual Report on Form 10-K for the year ended December 31, 2008 and other documents subsequently filed with or furnished to the Securities and Exchange Commission. 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.

SOURCE Sequenom, Inc.