SAN DIEGO, July 21, 2014 /PRNewswire/ -- Sequenom, Inc.
(NASDAQ: SQNM), a life sciences company providing innovative
genetic analysis solutions, today announced that its wholly owned
subsidiary, Sequenom Laboratories, will soon launch the
VisibiliT™ laboratory-developed test in international markets. The
VisibiliT test utilizes maternal age, fetal fraction and the
relative amount of chromosomal material for chromosomes 21 and 18
to generate a highly accurate, personalized risk score. The
VisibiliT test is for pregnant women who want information about
common fetal trisomies (Down syndrome and Edwards syndrome), have a
single gestation pregnancy, and whose pregnancies are considered to
be at average risk. The test can also report fetal gender. With the
VisibiliT test, Sequenom Laboratories fulfills its goal to expand
its noninvasive prenatal testing (NIPT) menu with the development
of a low-cost test by year-end to facilitate international
access.
"This is an important development because it makes an excellent
test much more affordable and accessible to a wider spectrum of
pregnant women throughout the world," said Professor Kypros Nicolaides, M.D., director of the Fetal
Medicine Foundation and the Harris Birthright Research Centre for
Fetal Medicine at King's College Hospital in London.
Performance of the VisibiliT test was determined by a clinical
evaluation study of over 1,000 samples, and demonstrated a greater
than 99% sensitivity and specificity for trisomies 21 and 18. A
poster entitled, 'Application of risk-score analysis to
low-coverage whole genome sequencing data for the noninvasive
detection of trisomy 21 and trisomy 18,' will be presented at the
18th International Conference on Prenatal Diagnosis and
Therapy (ISPD) taking place July
20-23 in Brisbane,
Australia.
Building a global portfolio of laboratory-developed tests for
noninvasive prenatal assessment
Sequenom Laboratories is the first test service provider to
offer two distinct NIPT options—MaterniT21™ PLUS and
VisibiliT—enabling greater testing access and flexibility for
providers and patients.
"The launch of the VisibiliT test is an important achievement
for the company, as we are expanding our noninvasive prenatal
testing menu to provide additional choices to better serve the
broader prenatal testing community," said William Welch, Chief Executive Officer of
Sequenom, Inc. "We are committed to innovating and building upon
our market-leading NIPT services and solutions as we continue to
provide valuable information to health care professionals and their
patients around the world."
The VisibiliT test will be available to international markets
beginning in August. Sequenom Laboratories will continue ongoing
discussions with payors in the U.S. and is prepared to offer the
test in the U.S. as insurance coverage develops.
The technology at the forefront of prenatal testing
Sequenom Laboratories first pioneered the use of NIPT in 2011,
with the introduction of the MaterniT21 PLUS laboratory-developed
test that's benefited more than 250,000 pregnant women worldwide.
Because of this advance, thousands of pregnant women have avoided
potentially unnecessary invasive procedures while still gaining
critical genetic information about the health of their pregnancies.
The VisibiliT test maintains the same Sequenom Laboratories'
commitment to quality and accuracy that's featured in the
MaterniT21 PLUS test.
Using a maternal blood sample, the VisibiliT and MaterniT21 PLUS
tests analyze chromosomal material in cell-free fetal DNA
of pregnant women. The VisibiliT test reports a risk score for
common fetal chromosomal abnormalities, specifically trisomies 21
and 18, as well as fetal gender. The MaterniT21 PLUS test, by
contrast, reports both common and rare fetal chromosomal
abnormalities—from trisomies 21, 18 and 13 to fetal sex
aneuploidies, trisomies 16, 22, fetal gender and select
microdeletions.
Both tests were developed, validated and are performed
exclusively by Sequenom Laboratories. Test results are provided to
the ordering health care provider.
Sequenom Laboratories Presentations at
ISPD
Tuesday, July 22,
2014, Session 6: Screening for aneuploidy / NIPT
- 11:06-11:16 a.m. – NIPT 2.0:
Identification of 22q microdeletions by noninvasive prenatal
testing; Presenter: Juan-Sebastian
Saldivar
- 11:39 – 11:45 a.m. – Genome wide
analysis of sub-chromosomal copy number variations using NIPT in
over 4500 patients; Presenter: Dirk van den
Boom
Sequenom Scientific Posters at ISPD
- Characterization and targeted isolation of circulating
cell-free DNA for the noninvasive prenatal MaterniT21™ PLUS
LDT
- Noninvasive detection of a balanced fetal translocation from
maternal plasma
- Detection of fetal subchromosomal abnormalities by sequencing
circulating cell-free DNA from maternal plasma
- Factors affecting levels of circulating cell-free fetal DNA in
maternal plasma and their implications for noninvasive prenatal
testing
- Evaluation of targeted methodologies for the noninvasive
detection of fetal aneuploidies
- Prenatal detection of fetal aneuploidy on the Ion Torrent
proton platform
- Application of risk score analysis to low-coverage whole genome
sequencing data for the noninvasive detection of trisomy 21 and
trisomy 18
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. Website:
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 name HerediT™, MaterniT21™ PLUS, RetnaGene™, SensiGene™
and VisibiliT™, these molecular genetic laboratory-developed tests
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®, HerediT™, MaterniT21™ PLUS, RetnaGene™, SensiGene™
and VisibiliT™, 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 expected launch
and availability in August of Sequenom Laboratories' VisibiliT
test, the impact and benefits of the test including affordability
and accessibility to a wider spectrum of pregnant women throughout
the world, Sequenom's commitment to innovating and building upon
its market leading NIPT services and solutions and its ability to
continue to provide valuable information to health care
professionals and their patients, and Sequenom Laboratories' plans
to continue ongoing discussions with payors in the U.S. and its
preparation to offer the test in the U.S. as insurance coverage
develops, 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 Sequenom's ability to develop and commercialize new
technologies and products, particularly new technologies such as
prenatal and other diagnostics and laboratory developed tests such
as the VisibiliT test, Sequenom's ability to manage its existing
cash resources or raise additional cash resources, competition,
intellectual property protection and intellectual property rights
of others, government regulation particularly with respect to
diagnostic products and laboratory developed tests, obtaining or
maintaining regulatory approvals, ongoing patent litigation, and
other risks detailed from time to time in Sequenom, Inc.'s most
recent Quarterly and Annual Reports on Securities and Exchange
Commission Forms 10-Q and 10-K, respectively, 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.