SAN DIEGO, April 16, 2013 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced that earlier this month, its wholly owned subsidiary, the Sequenom Center for Molecular Medicine (Sequenom CMM), surpassed 100,000 MaterniT21™ PLUS test samples processed since the launch of its laboratory developed test (LDT) in October of 2011. The MaterniT21 PLUS test was the first commercial non-invasive prenatal test (NIPT) of its kind for the detection of a genetic chromosomal anomaly known as Trisomy 21, the most common cause of Down syndrome.
"There has been a significant clinical benefit of incorporating NIPT technology, such as the MaterniT21 PLUS test, into my practice, and I expect to see this technology utilized as a best practice tool among women at high risk of fetal aneuploidy," said Arnold Cohen, MD, Chairman, Department of Obstetrics and Gynecology, Albert Einstein Medical Center in Philadelphia. "The MaterniT21 PLUS test has enabled me to provide more accurate prenatal test results in a timely manner. It's reliability and ease of use is of great value to my patients and their families."
The MaterniT21 PLUS test has shown high accuracy, precision and sensitivity, and it is offered by Sequenom CMM as outlined by The American College of Obstetricians and Gynecologists Committee on Genetics and the Society for Maternal-Fetal Medicine Publications Committee joint recommendation supporting NIPT in pregnant women at high risk of carrying a fetus with fetal aneuploidy.
"This milestone represents the overwhelmingly positive response we have received from the obstetrics community to the MaterniT21 PLUS test, and we believe the physician loyalty and interest in our offerings validate the superior attributes of our testing services and support," said William Welch, President and COO, Sequenom, Inc. "With the expansion of our testing capacity and continued investment in our team dedicated solely to providing physicians with education and support for the MaterniT21 PLUS test, we expect that Sequenom CMM will surpass the next milestone of accessioning 150,000 test samples in 2013."
In response to the rapid volume growth and medical community adoption of the MaterniT21 PLUS test, Sequenom CMM is in the process of increasing its testing capacity by completing the validation and licensure of an additional location in North Carolina. This additional location is expected to be operational in the second half of 2013 and will increase the total NIPT capacity from the current 200,000 test samples per year to a minimum of 300,000 test samples per year. At the close of December 2012, the annualized run rate for the MaterniT21 PLUS test was more than 120,000 test samples, an average of more than 2,300 samples weekly.
The MaterniT21 PLUS LDT analyzes the relative amount of 21, 18, 13, as well as X and Y chromosomal material in cell-free DNA. The test is intended for use in pregnant women at increased risk for fetal aneuploidy and can be used as early as 10 weeks' gestation. Estimates suggest there are about 750,000 pregnancies at high risk for fetal aneuploidy each year in the United States. The MaterniT21 PLUS test is available exclusively through the Sequenom CMM as a testing service provided to physicians. To learn more about the test, please visit www.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®, MaterniT21™ and MaterniT21™ PLUS are trademarks of Sequenom, Inc. All other trademarks and service marks are the property of their respective owners.
About Sequenom Center for Molecular Medicine Sequenom Center for Molecular Medicine (Sequenom CMM®) is a CAP accredited and CLIA-certified molecular diagnostics reference laboratory currently with two locations dedicated to the development and commercialization of laboratory developed tests for prenatal and eye conditions and diseases. Utilizing innovative proprietary technologies, Sequenom CMM provides test results that can be used by health care professionals in managing patient care. Testing services are available only upon request by physicians. Sequenom CMM works 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 tests. Sequenom CMM is changing the landscape in genetic diagnostics. Visit http://www.sequenomcmm.com for more information on laboratory testing services.
Forward-Looking Statements Except for the historical information contained herein, the matters set forth in this press release, including statements regarding increasing demand from for Sequenom CMM's prenatal tests, growing Sequenom CMM's market presence, sales expansion and establishing its leadership position, the Company's 2013 expectations regarding test volumes, capacity expansion including the opening, build-out, and licensure of a third laboratory location in North Carolina for Sequenom CMM, the Company's commitment to improving healthcare through revolutionary genetic analysis solutions, and Sequenom CMM's dedication to the development and commercialization of laboratory developed tests for prenatal and eye conditions and diseases, and changing the landscape in genetic 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 of technology and tests such as the MaterniT21 PLUS test, reliance upon the collaborative efforts of other parties such as, without limitation, healthcare providers, international distributors and licensees, the Company or third parties obtaining or maintaining regulatory approvals that impact the Company's business, government regulation particularly with respect to diagnostic products and laboratory developed tests, publication processes, the performance of designed product enhancements, the Company's ability to develop and commercialize technologies and products, particularly new technologies such as noninvasive prenatal diagnostics, laboratory developed tests, and genetic analysis platforms, the Company's financial position, 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, 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 for the quarter ended September 30, 2012, its most recently filed reports on Form 8-K, and its most recently filed 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.