Sequenom CMM Opens New CLIA Lab Facility In North Carolina
SAN DIEGO, June 12, 2013 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced that its wholly owned subsidiary, the Sequenom Center for Molecular Medicine (Sequenom CMM), has completed the build-out and validation of an additional laboratory location in Raleigh-Durham, NC, and is now processing patient samples commercially. This new laboratory location adds capacity and redundancy to the existing Sequenom CMM laboratory locations in California and Michigan.
With an initial capacity of 100,000 tests per year, the North Carolina facility will primarily support processing of the MaterniT21 PLUS laboratory-developed test (LDT) and will immediately increase Sequenom CMM's total MaterniT21 PLUS testing capacity to over 300,000 test samples per year. This practice-changing prenatal LDT analyzes the relative amount of chromosome 21, 18, and 13, as well as X and Y material in cell-free fetal DNA obtained from a maternal blood sample as early as 10 weeks of pregnancy.
"We are excited about the opening in North Carolina of our third US-based laboratory location. Our investment in establishing this new presence on the East coast will allow us to better meet the needs of health care providers by providing critical additional capacity and geographic back-up needed to address the rapidly growing adoption of our testing services," said William Welch, President and COO, Sequenom, Inc.
The new laboratory location received its Clinical Laboratory Improvement Amendments (CLIA) registration for operation in May of 2013.
The MaterniT21 PLUS LDT is intended for use in pregnant women at increased risk for fetal aneuploidy. 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.
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®, Sequenom CMM® , MaterniT21™ and MaterniT21™ PLUS are trademarks of Sequenom, Inc.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company's expectations regarding the impact, utility and benefits of the North Carolina facility, and the growing adoption of Sequenom CMM's testing services, 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 timing and amount of reimbursement that Sequenom CMM receives from payors for its laboratory developed tests, 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, 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.
SOURCE Sequenom, Inc.