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Sequenom CMM Commences Pivotal Clinical Validation Study for Its SensiGene Trisomy 21 Laboratory Developed Test

SAN DIEGO, Dec. 22, 2010 /PRNewswire/ -- Sequenom, Inc. (Nasdaq: SQNM) today announced that the company's wholly-owned reference laboratory, the Sequenom Center for Molecular Medicine (Sequenom CMM), has authorized commencement of a pivotal clinical validation study. This validation study is designed to evaluate the clinical performance of the SensiGene T21 Laboratory Developed Test (LDT) for the detection of an overabundance in maternal blood of chromosome 21, which is associated with fetal chromosome 21 aneuploidy. Testing of the clinical specimens will be performed at the Sequenom CMM facility in San Diego.


In September 2010, Sequenom CMM completed an R&D "locked-assay" verification study and the results of this study have been accepted for publication by the American Journal of Obstetrics and Gynecology. This "locked-assay" study was performed on the GAIIx sequencer (Illumina, Inc., CA). Subsequently the laboratory has been engaged in additional equivalency studies using the more advanced HiSeq 2000 sequencer (Illumina). Earlier this month, Sequenom CMM scientists and Sequenom's oversight committee reviewed data from the equivalency studies and authorized the start of the LDT clinical validation study using the HiSeq 2000.

Sequenom CMM-San Diego has received the first set of clinical specimens for the study and plans to start testing samples during the first week of January 2011.

"We are delighted that Sequenom CMM will initiate the LDT clinical validation study," said Harry F. Hixson, Jr., Ph.D., chairman and chief executive officer of Sequenom. "We remain very pleased with the results of the 480 sample R&D verification study that was completed in September 2010. Results from our just completed HiSeq 2000 equivalency study met pre-specified requirements that now allow us to proceed confidently with the validation study. The LDT clinical validation study is an important next step in confirming the trisomy 21 test performance in a large sample cohort."

Additionally, the company reports that Federal and State CLIA certificates were issued to Sequenom CMM-San Diego effective October 26, 2010.

About Sequenom Center for Molecular Medicine

Sequenom Center for Molecular Medicine (Sequenom CMM®) is a CAP-accredited and CLIA-certified specialty reference laboratory dedicated to the development and commercialization of laboratory-developed genetic testing services for prenatal and eye conditions. Utilizing innovative proprietary technologies, Sequenom CMM provides genetic testing results services upon orders from physicians. Working closely with key opinion leaders and experts in obstetrics, retinal care and genetics, Sequenom CMM scientists use a variety of sophisticated and cutting-edge methodologies in the development and validation of laboratory tests. Sequenom CMM is changing the landscape in genetic diagnostics. Visit 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 and 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 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 CMM®, SensiGene® are trademarks of Sequenom, Inc. All other trademarks 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 Company's expectations, plans, goals, purpose, design, and commencement and performance of the clinical validation study, including sample testing and the timing thereof, the impact of Sequenom CMM on genetic diagnostics, and the Company's commitment to improving healthcare through revolutionary genetic analysis solutions, 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 the Company's ability to develop and commercialize new technologies and products, particularly new technologies such as  noninvasive prenatal diagnostics and laboratory developed tests, reliance upon the collaborative efforts of other parties, the Company's ability to manage its existing 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, ongoing litigation and investigations and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K 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.
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