All Sequenom CMM Laboratory Locations CLIA-Certified and CAP-Accredited with Receipt of CAP Accreditation in North Carolina
SAN DIEGO, Aug. 5, 2013 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced that the New York Department of Health's Wadsworth Center Clinical Laboratory Evaluation Program (CLEP) has issued a clinical laboratory permit to allow the Sequenom Center for Molecular Medicine's (Sequenom CMM) San Diego facility to provide its noninvasive prenatal laboratory-developed test, the MaterniT21™ PLUS test, to healthcare professionals in the state of New York, effective August 1, 2013.
In addition, Sequenom CMM's CLIA laboratory location in North Carolina has received accreditation by the College of American Pathologists (CAP), indicating that it has met all applicable standards required by the organization to provide quality laboratory services. At this time, Sequenom CMM offers bicoastal laboratory testing services to healthcare professionals, as all three laboratory sites located in California, Michigan and North Carolina are CLIA-certified and CAP-accredited, demonstrating they meet the highest quality and safety standards for laboratory testing.
"The New York licensure and approval process is a very detailed and complex evaluation by a regulatory body to ensure the accuracy and reliability of laboratory testing that is provided throughout New York State, and we believe the successful CLEP permit, in addition to the recent CAP accreditation in North Carolina, further validate the clinical, technical and scientific merits of our industry-leading noninvasive prenatal technology," said Allan Bombard, M.D., Chief Medical Officer of Sequenom, Inc. "We are proud of the issuance of the New York State Department clinical laboratory permit that will enable healthcare providers to offer critical and timely information to expectant families, and we look forward to working with physicians in New York to better serve their patients."
The MaterniT21 PLUS test 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 increased 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.
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.
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 three 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.
SEQUENOM®, and MaterniT21™ PLUS are trademarks of Sequenom, Inc. All other trademarks and service marks are the property of their respective owners.
Except for historical information contained herein, the matters set forth in this press release, including statements regarding the Company's expectations, 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, 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, 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 filings with the Securities and Exchange Commission, including without limitation its Quarterly Report on Form 10-Q for the quarter ended June 30, 2013 and its Annual Report on Form 10-K for the year ended December 31, 2012. 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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