Sequenom CMM Achieves Milestone Of 100,000 MaterniT21™ Plus Tests Processed
SAN DIEGO, April 16, 2013
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
"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.
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
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
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.
SOURCE Sequenom, Inc.
Contact: Marcy Graham, Senior Director, Investor Relations & Corp Comm,
Sequenom, Inc., +1-858-202-9028, email@example.com, or Jakob Jakobsen,
Media Contact, Chandler Chicco Agency, +1-310-309-1003,
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