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SEQUENOM Announces Launch of SensiGene Cystic Fibrosis Carrier Screening Test

SAN DIEGO, Sept. 17 /PRNewswire-FirstCall/ -- SEQUENOM, Inc. (Nasdaq: SQNM) today announced that the company's first laboratory developed test, the SensiGene(TM) Cystic Fibrosis (CF) Carrier Screening test, has been launched. This test is available exclusively through the Sequenom Center for Molecular Medicine, a next-generation CLIA (Clinical Laboratory Improvement Amendments, 1988) molecular diagnostic laboratory and a wholly-owned subsidiary of Sequenom, Inc.


The SensiGene CF Carrier Screening Test

  • This innovative test screens for 103 mutations and five variants, including the 23 mutations recommended by the American College of Medical Genetics (ACMG). This test has been shown to identify each of the 103 mutations and five variants through genomic DNA and DNA control testing.
  • The test offers superior detection rates and broader ethnic coverage when compared to the standard ACMG 23 recommended mutations panel. Because of the increased difficulty in assigning a single ethnicity to an individual, expanded CF panels can provide increased sensitivity for CF carrier screening for many individuals. Having a more comprehensive mutation panel is important as 1 in 17 CF carriers may be missed using a standard ACMG 23 CF carrier screening panel.
  • The test employs Sequenom's proprietary MassARRAY(R) system, which allows direct and label-free analysis of nucleic acids.

"As the world's population becomes more of a melting pot in terms of ethnicity and diversity, a more comprehensive test like the SensiGene Cystic Fibrosis Carrier Screening test is essential in the world of genetic testing," said Lee P. Shulman MD, Professor in Obstetrics and Gynecology and Chief of the Division of Reproductive Medicine at the Feinberg School of Medicine at Northwestern University.

Carrier screening tests help identify individuals who may have an increased risk of having a baby with certain genetic conditions. Healthy individuals with no family history of the condition and that already have healthy children, may be carriers of a genetic condition; for example, cystic fibrosis. Approximately 1 in 30 Americans - more than 10 million people - are carriers of a cystic fibrosis gene mutation, making it one of the most common genetic disorders in the United States. Children have cystic fibrosis when they have two mutations in the gene that cause CF - inheriting one mutation from the mother and the other from the father. According to the American College of Obstetricians and Gynecologists (ACOG) and the ACMG, cystic fibrosis carrier screening should be offered to all Caucasian couples who are expecting a baby or are considering pregnancy, and further, should be made available to all patients regardless of ethnicity. About 1.1 million cystic fibrosis carrier screening tests are performed each year in the U.S. With an average reimbursement rate of $200-$400 per test; the U.S. market is estimated to be in excess of $300 million per year.

"The commercial launch of this test is an important milestone for us as it marks the first laboratory developed test launched by our lab, the Sequenom Center for Molecular Medicine," stated Harry Stylli, PhD, Sequenom's president and chief executive officer. "This screening tool offers an outstanding testing option for patients and their care providers. We are developing and plan to offer a menu of superior women's health related molecular tests, including proprietary, cell free fetal nucleic acid based tests such as fetal sex determination, fetal RHD genotyping, trisomy 21 and others."

About Cystic Fibrosis

Cystic fibrosis is one of the most common genetic disorders in the U.S. It is caused by changes in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Changes in this gene cause the body to produce thick mucus that can affect breathing, digestion and other organs. CF does not affect everyone the same way; the severity of symptoms is different from person to person. The most common symptoms include persistent coughing, frequent lung infections, like pneumonia or bronchitis, wheezing or shortness of breath, and poor growth/weight gain in spite of a good appetite.

About MassARRAY

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 CMM)

In 2008, Sequenom acquired a CAP accredited and CLIA-certified molecular diagnostic laboratory located in Grand Rapids, Mich. and named it the Sequenom Center for Molecular Medicine. Through this laboratory, we plan to develop and commercialize a full range of cutting-edge diagnostic tests intended for physicians and that focus on women's health. In addition to the new SensiGene Cystic Fibrosis Carrier Screening test, Sequenom CMM is also developing noninvasive prenatal tests using a technology that derives fetal information from a maternal blood sample; the planned menu includes tests for fetal RHD genotyping, Fetal(xy) (fetal sex determination), trisomy 21, and others. For more information please visit


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, Calif. Sequenom maintains a Web site at 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(R) and SensiGene(TM) 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 of the SensiGene Cystic Fibrosis Carrier Screening test, and the Company's and Sequenom CMM's development of and plans to develop, commercialize and offer other molecular tests (including noninvasive prenatal tests and tests related to women's health), 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 Cystic Fibrosis Carrier Screening test, the Company's ability to develop and commercialize new tests, technologies and products, particularly new technologies related to oncology and women's health and including noninvasive prenatal and other diagnostics and laboratory developed tests, 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, the independent investigation 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.

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