MADISON, N.J. and SAN DIEGO, June 16,
2014 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a
life sciences company providing innovative genetic analysis
solutions, and Quest Diagnostics (NYSE:DGX), the world's leading
provider of diagnostic information services, today announced an
agreement under which Quest will offer national access to Sequenom
Laboratories' MaterniT21™ PLUS laboratory-developed test
(LDT). Using a maternal blood sample, the noninvasive prenatal test
(NIPT) analyzes chromosomal material in cell-free fetal DNA
of pregnant women at increased risk for fetal chromosomal
abnormalities. Quest expects to begin offering access to the test
in the third quarter.
In addition, Quest has formed a license agreement with Sequenom
for certain NIPT patents and patent applications. The license
agreement is the first formed by Sequenom with a commercial lab in
the United States. Quest intends
to use the intellectual property for the purposes of developing and
validating its own proprietary lab-developed NIPT test. Quest
expects to introduce this new offering in 2015. Additional terms of
the agreement were not disclosed.
"Noninvasive prenatal testing is one of the most promising new
areas of medicine because it delivers highly actionable insights
for empowering critical health decisions," said Charles (Buck) Strom, MD, PhD, Senior Medical
Director, Genetics, Quest Diagnostics. "The MaterniT21 PLUS test
stands out for its technological sophistication and clinical
usefulness, and is the most well validated to date of the NIPT
offerings. Offering access to this test strongly aligns with our
strategy to deliver guideline-backed testing services based on the
most advanced technologies in order to improve healthcare for
patients."
A December 2012 medical opinion
from the American Congress of Obstetricians and Gynecologists
(ACOG) and the Society of Maternal Fetal Medicine (SMFM) supports
the use of cell-free fetal DNA testing as an option for primary
screening for women at increased risk of aneuploidy (abnormal
chromosomal number), including those 35 years of age or older or
who have a history of ultrasound abnormalities in pregnancy.
"We are pleased to establish
a nationwide partnership with Quest, the world's
leading provider of diagnostic information
services," said William Welch, Chief
Executive Officer of Sequenom, Inc. "Quest is a
superb partner to further extend access to our MaterniT21
PLUS test to physicians and their patients seeking
to make the most well informed decisions possible."
Sequenom Laboratories was the first to market a noninvasive
prenatal laboratory-developed test for fetal chromosomal
aneuploidies. The MaterniT21 PLUS test analyzes the relative amount
of 21, 18, 13, as well as select other chromosomal material and
micro deletions and duplications in cell-free DNA. The
MaterniT21 PLUS test may be used for pregnant women at increased
risk for fetal chromosomal abnormalities.
Once available, physicians will be able to order the test
through Quest Diagnostics, which will forward specimens for testing
to Sequenom Laboratories.
Estimates suggest about 750,000 pregnancies may be at high risk
for fetal chromosomal abnormalities each year in the United States.
Quest Diagnostics Women's Health Services
Quest
Diagnostics is provider of comprehensive diagnostic information
services for women's health disorders across the continuum of a
woman's life. The company's specialized services feature one of the
broadest menus of genetic services for pregnancy, including carrier
screening for spinal muscular atrophy, cystic fibrosis and fragile
X syndrome. The company also provides diagnostic information
services for cervical, breast and ovarian cancer, and sexually
transmitted diseases and reproductive tract infections. In
addition, Quest Diagnostics provides genetic counseling services
for clinicians and parents and publishes original research on
women's health issues in peer-reviewed journals and at scientific
conferences.
About Quest Diagnostics
Quest Diagnostics is the
world's leading provider of diagnostic information services that
patients and doctors need to make better healthcare decisions. The
company offers the broadest access to diagnostic information
services through its network of laboratories and patient service
centers, and provides interpretive consultation through its
extensive medical and scientific staff. Quest Diagnostics is a
pioneer in developing innovative diagnostic tests and advanced
healthcare information technology solutions that help improve
patient care. Additional company information is available at
QuestDiagnostics.com. Follow us at
Facebook.com/QuestDiagnostics and Twitter.com/QuestDX.
About Sequenom
Sequenom, Inc. (NASDAQ: SQNM) is a life
sciences company committed to improving healthcare through
revolutionary genomic and genetic analysis solutions. Sequenom
develops innovative technology, products and diagnostic tests that
target and serve molecular diagnostic markets. Web site:
www.sequenom.com.
About Sequenom Laboratories
Sequenom Laboratories, a
CAP accredited and CLIA-certified molecular diagnostics laboratory,
has developed a broad range of laboratory tests, with a focus on
prenatal and ophthalmological diseases and conditions. Branded
under the names SensiGene®, MaterniT21™ PLUS, HerediT™,
NextView™ and RetnaGene™, these molecular genetic
laboratory-developed tests, performed exclusively by Sequenom
Laboratories, provide early patient management information for
obstetricians, geneticists, maternal fetal medicine specialists and
ophthalmologists. Sequenom Laboratories is changing the landscape
in genetic disorder diagnostics using proprietary cutting edge
technologies.
Sequenom®, MaterniT21™ PLUS, SensiGene®,
HerediT™, NextView™, and RetnaGene™ are trademarks of Sequenom,
Inc. All other trademarks and service marks are the property of
their respective owners.
Forward-Looking Statements
Except for the historical
information contained herein, the matters set forth in this press
release, including statements regarding Sequenom's and Quest
Diagnostics' expectations related to future performance under the
agreements between Sequenom and Quest Diagnostics, the expected or
potential benefits and impact of those agreements on Sequenom,
patients and physicians, expected expansion of patient access to
the MaterniT21 PLUS test and the expected availability and timing
of Quest Diagnostics' offering access to the test, Quest
Diagnostics' intentions, plans, and strategy based on the
agreements, Sequenom's commitment to improving healthcare through
revolutionary genomic and genetic analysis solutions, and Sequenom
Laboratories' changing the landscape in genetic disorder
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 Quest Diagnostics, healthcare
providers and others, Sequenom or third parties obtaining or
maintaining regulatory approvals that impact Sequenom's business,
government regulation particularly with respect to diagnostic
products and laboratory developed tests, publication processes, the
performance of designed product enhancements, Sequenom's ability to
develop and commercialize technologies and products, particularly
new technologies such as noninvasive prenatal diagnostics and
laboratory developed tests, Sequenom's financial position, the
timing and amount of reimbursement that Sequenom Laboratories
receives from payors for its laboratory developed tests, Sequenom'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
Sequenom, and other risks detailed from time to time in Sequenom's
most recently filed reports on Form 8-K, its most recently filed
Quarterly Report on Form 10-Q and its Annual Report on Form 10-K/A
and 10-K for the year ended December 31,
2013, 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 Sequenom
undertakes no obligation to revise or update any forward-looking
statement to reflect events or circumstances after the issuance of
this press release.
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SOURCE Sequenom, Inc.