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Sequenom Labs Reports Expanded Int'l Noninvasive Prenatal Testing Service with VisibiliT Test

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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
18^th 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

o 11:06-11:16 a.m. – NIPT 2.0: Identification of 22q microdeletions by
noninvasive prenatal testing; Presenter: Juan-Sebastian Saldivar
o 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

o Characterization and targeted isolation of circulating cell-free DNA for
the noninvasive prenatal MaterniT21™ PLUS LDT
o Noninvasive detection of a balanced fetal translocation from maternal
plasma
o Detection of fetal subchromosomal abnormalities by sequencing circulating
cell-free DNA from maternal plasma
o Factors affecting levels of circulating cell-free fetal DNA in maternal
plasma and their implications for noninvasive prenatal testing
o Evaluation of targeted methodologies for the noninvasive detection of
fetal aneuploidies
o Prenatal detection of fetal aneuploidy on the Ion Torrent proton platform
o Application of risk score analysis to low-coverage whole genome sequencing
data for the noninvasive detection of trisomy 21 and trisomy 18

Posted-In: News FDA Press Releases

 

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