The American College of Obstetricians and Gynecologists Committee on Genetics
and the Society for Maternal-Fetal Medicine Publications Committee Recommend
Noninvasive Prenatal Testing for Fetal Aneuploidy
SAN DIEGO, Nov. 21, 2012
SAN DIEGO, Nov. 21, 2012 /PRNewswire/ --Sequenom, Inc. (NASDAQ: SQNM), a life
sciences company providing innovative diagnostic testing and genetic analysis
solutions, today announced that the American College of Obstetricians and
Gynecologists (ACOG) Committee on Genetics and the Society for Maternal-Fetal
Medicine (SMFM) Publications Committee issued a joint Committee Opinion on
November 20, 2012, recommending that cell-free fetal DNA testing be offered to
patients at increased risk of aneuploidy. It can also be used as a follow-up
test for women with a positive first-trimester or second-trimester screening
Previously, the ACOG recommended that women, regardless of maternal age, be
offered prenatal assessment for aneuploidy by screening or invasive prenatal
diagnosis. The ACOG Committee on Genetics and the SMFM Publications Committee
now recommend that women at increased risk of aneuploidy be offered cell-free
fetal DNA as an option that can be used as a primary screening test based on
the following indications:
oMaternal age 35 years or older at delivery.
oFetal sonographic findings indicating an increased risk of aneuploidy.
oHistory of a prior pregnancy with a trisomy.
oPositive test result for aneuploidy, including first trimester,
sequential, or integrated screen, or a quadruple screen.
oParental balanced robertsonian translocation with increased risk for fetal
trisomy 13 or 21.
The Committee Opinion also recommended that "cell-free fetal DNA testing
should not be offered to low-risk women or women with multiple gestations
because it has not been sufficiently evaluated in these groups." Further, the
Committee Opinion stated that "pre-test counseling should be an informed
patient choice after pre-test counseling and should not be part of routine
prenatal laboratory assessment. A patient with a positive test result should
be referred for genetic counseling and offered invasive prenatal diagnosis for
confirmation of test results."
"The issuance of the ACOG/SMFM opinion on the use of cell-free fetal DNA
testing represents a major step forward for the integration of this valuable
technology into pregnancy care programs" said Allan Bombard, MD, Sequenom's
Chief Medical Officer. "We fully support the indications for considering the
use of cell-free fetal DNA outlined in the Committee Opinion and believe this
will be a valuable tool to help guide physicians and their patients in the
most appropriate prenatal care."
ACOG is the nation's leading group of physicians providing health care for
women. The College strongly advocates for quality health care for women,
maintains the highest standards of clinical practice and continuing education
of its members, promotes patient education, and increases awareness among its
members and the public of the changing issues facing women's health care.
SMFM is a non-profit membership group for obstetricians/gynecologists who have
additional formal education and training in maternal-fetal medicine. The
society is devoted to reducing high-risk pregnancy complications by providing
continuing education to its 2,000 members on the latest pregnancy assessment
and treatment methods. It also serves as an advocate for improving public
policy, and expanding research funding and opportunities for maternal-fetal
The full text of the Committee Opinion can be found at: Noninvasive prenatal
testing for fetal aneuploidy. Committee Opinion No. 545. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2012: 120:1532-4.
About the MaterniT21 PLUS Test
The MaterniT21 PLUS test analyzes the relative amount of 21, 18, 13 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 Center for
Molecular Medicine (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 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 CMM, LLC
Sequenom Center for Molecular Medicine® (Sequenom CMM), a CAP accredited and
CLIA-certified molecular diagnostics laboratory, is developing a broad range
of laboratory developed tests with a focus on prenatal and ophthalmic diseases
and conditions. These laboratory-developed tests provide beneficial patient
management options for obstetricians, geneticists and maternal fetal medicine
specialists, and retinal specialists. Sequenom CMM is changing the landscape
in genetic disorder diagnostics using proprietary cutting edge technologies.
Except for the historical information contained herein, the matters set forth
in this press release, including statements regarding the integration of
cell-free fetal DNA testing into pregnancy care programs, the expected impact
and benefits of the new guidelines on physicians and patients, and Sequenom
CMM changing the landscape in genetic disorder diagnostics using proprietary
cutting edge technologies, 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 including without limitation
any international distributors or 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 filings with the Securities and
Exchange Commission, including without limitation its Quarterly Report on Form
10-Q for the quarter ended September 30, 2012 and its Annual Report on Form
10-K for the year ended December 31, 2011. 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., or +1-858-202-9028, email@example.com, or Jakob Jakobsen,
or Chandler Chicco Agency, +1-310-309-1003,
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