Sequenom CMM Opens New CLIA Lab Facility In North Carolina
SAN DIEGO, June 12, 2013
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
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 ofpregnancy.
"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
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.
Contact: Marcy Graham, Senior Director, Investor Relations & Corp Comm,
Sequenom, Inc., 858-202-9028, firstname.lastname@example.org or Jakob Jakobsen, Media
Contact, Chandler Chicco Agency, 310-309-1003,
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