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Last updated on April 19, 2014 at 7:48 EDT

Study In Prenatal Diagnosis Finds Sequenom CMM’s MaterniT21(TM) PLUS Lab-developed Test Accurately Detects Fetal Trisomies In Pregnant Women Carrying Twins Or Triplets

May 18, 2012

SAN DIEGO, May 18, 2012 /PRNewswire/ — Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced that a new publication from the large Women & Infants multi-center clinical study on the Sequenom Center for Molecular Medicine’s (Sequenom CMM) MaterniT21 PLUS laboratory-developed test (LDT) has been published online in the peer-reviewed journal, Prenatal Diagnosis. Along with this week’s publication, the Company announces that as of the week ended May 12, 2012, Sequenom CMM has processed more than 10,000 commercial MaterniT21 PLUS test samples in 2012.

The publication addresses the capability of the MaterniT21 PLUS LDT to accurately detect the presence of certain fetal trisomies in pregnant women carrying twins or triplets. The paper will appear in the journal’s May issue and the full abstract can be found online at: http://onlinelibrary.wiley.com/doi/10.1002/pd.3892/abstract.

“The underlying biology and these positive study data provide evidence that this type of DNA-testing can be reliably employed as a clinical management option for women expecting twins or triplets who are at increased risk for fetal chromosome anomalies,” said Allan Bombard, M.D., Laboratory Director for Sequenom Center for Molecular Medicine.

The published results are derived from the large international, multi-center study conducted at 27 prenatal diagnostic centers worldwide, with previous publications on trisomy 21 and trisomies 18 and 13 in Genetics in Medicine. Participating sites collected and processed maternal plasma samples from 4,664 pregnant women in the late first and early second trimester who were at increased risk for fetal aneuploidy. Blinded samples from pregnancies with trisomy 21, trisomy 18, and trisomy 13 as well as those with other abnormal karyotypes were tested.

In the same multi-center study, maternal plasma samples were tested from 25 twin and two triplet pregnancies. Of the twin pregnancies, there were no trisomies in 17 pregnancies (known as euploid), trisomy 21 in seven (two cases of trisomy 21 in both fetal twins, five cases of trisomy 21 in one fetal twin only), and trisomy 13 in one (in one fetal twin). There were two triplet pregnancies, neither of which had trisomies. The MaterniT21 PLUS technology correctly classified the eight twin pregnancies with trisomy 21 or trisomy 13, the 17 twin euploid pregnancies and both triplet euploid pregnancies.

“We know that, in the U.S., pregnant women carrying twins or higher multiples are becoming more common due to the use of assisted reproductive technologies and acknowledge that more of these women have increased risks for fetal aneuploidy, such as advanced maternal age,” said Harry F. Hixson, Jr., Ph.D., Chairman and CEO, Sequenom, Inc. “This published data provides valuable evidence to specialists that Sequenom CMM’s MaterniT21 PLUS LDT can provide reliable detection of certain fetal trisomies in twins, just as in single pregnancies.”

The research was led by Jacob Canick, PhD, and Glenn Palomaki, PhD, of the Division of Medical Screening and Special Testing in the Department of Pathology and Laboratory Medicine at Women & Infants Hospital and The Warren Alpert Medical School of Brown University. The study also included scientists at Sequenom Center for Molecular Medicine, San Diego, CA.

As of the week ended May 12, Sequenom CMM has processed more than 10,000 MaterniT21 PLUS tests in 2012. Due to the successful rate of adoption, the Company recently announced that it has increased its internal goal to 40,000 MaterniT21 PLUS tests billed in 2012, up from the original internal goal of 25,000 tests billed for the year. As of the last week in April, the 52-week run rate had increased to more than 45,000 tests.

The MaterniT21 PLUS LDT is available solely through Sequenom CMM as a testing service to physicians. To learn more about the test, please visit Sequenomcmm.com.

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 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 CMM, LLC
Sequenom Center for Molecular Medicine® (Sequenom CMM), a CAP accredited and CLIA-certified molecular diagnostics laboratory, is developing a broad range of laboratory developed tests with a focus on prenatal and ophthalmic diseases and conditions. These laboratory-developed tests provide beneficial patient management options for obstetricians, geneticists and maternal fetal medicine specialists. Sequenom CMM is changing the landscape in genetic disorder diagnostics using proprietary cutting edge technologies.

Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the intended use for and capabilities of the MaterniT21 PLUS test, expectations regarding the future performance, utility, and impact of the test, the Company’s goals for the number of MaterniT21 PLUS tests to be billed for 2012 and the 52-week run rate, the Company’s commitment to improving healthcare through revolutionary genetic analysis solutions, and Sequenom CMM changing the landscape in genetic disorder diagnostics, 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 products such as the MaterniT21 PLUS LDT, reliance upon the collaborative efforts of other parties, 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, 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, litigation involving the Company, and other risks detailed from time to time in the Company’s most recently filed Quarterly Report on Form 10-Q and Annual Report on Form 10-K for the year ended December 31, 2011, 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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SOURCE Sequenom, Inc.


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