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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
About SequenomSequenom, 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.
®, MaterniT21™ and MaterniT21™ PLUS are trademarks of Sequenom, Inc. All other trademarks and service marks are the property of their respective owners.