Sequenom Laboratories and Quest Diagnostics Collaborate to Expand Patient
Access to the MaterniT21™ PLUS Noninvasive Prenatal Test
MADISON, N.J. and SAN DIEGO, June 16, 2014
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 ofpregnant women at increased risk for fetal chromosomal
abnormalities. Quest expects to begin offering access to the test in the third
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
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 toestablish anationwidepartnershipwith Quest, the world's
leading provider of diagnostic information services,"saidWilliamWelch,
Chief ExecutiveOfficerof Sequenom, Inc."Quest isa superb partner to
further extend access toourMaterniT21 PLUS testtophysicians and
theirpatients 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
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/QuestDiagnosticsand Twitter.com/QuestDX.
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:
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
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.
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.
Contact: Quest Diagnostics Contacts, Wendy Bost (Media): 973-520-2800, Dan
Haemmerle (Investors): 973-520-2900; Sequenom Contacts: Carolyn Beaver, Chief
Financial Officer, Sequenom, Inc., 858-202-9028,
firstname.lastname@example.org; Rachel Kennedy, Media Contact, Chandler Chicco
Agency, 858-449-9575, email@example.com
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