Sequenom, Inc. SQNM, a
life sciences company providing innovative genetic analysis solutions, today
announced that earlier this month, its wholly owned subsidiary, the Sequenom
Center for Molecular Medicine (Sequenom CMM), surpassed 100,000 MaterniT21™
PLUS test samples processed since the launch of its laboratory developed test
(LDT) in October of 2011. The MaterniT21 PLUS test was the first commercial
non-invasive prenatal test (NIPT) of its kind for the detection of a genetic
chromosomal anomaly known as Trisomy 21, the most common cause of Down
syndrome.
"There has been a significant clinical benefit of incorporating NIPT
technology, such as the MaterniT21 PLUS test, into my practice, and I expect
to see this technology utilized as a best practice tool among women at high
risk of fetal aneuploidy," said Arnold Cohen, MD, Chairman, Department of
Obstetrics and Gynecology, Albert Einstein Medical Center in Philadelphia.
"The MaterniT21 PLUS test has enabled me to provide more accurate prenatal
test results in a timely manner. It's reliability and ease of use is of great
value to my patients and their families."
The MaterniT21 PLUS test has shown high accuracy, precision and sensitivity,
and it is offered by Sequenom CMM as outlined by The American College of
Obstetricians and Gynecologists Committee on Genetics and the Society for
Maternal-Fetal Medicine Publications Committee joint recommendation supporting
NIPT in pregnant women at high risk of carrying a fetus with fetal aneuploidy.
"This milestone represents the overwhelmingly positive response we have
received from the obstetrics community to the MaterniT21 PLUS test, and we
believe the physician loyalty and interest in our offerings validate the
superior attributes of our testing services and support," said William Welch,
President and COO, Sequenom, Inc. "With the expansion of our testing capacity
and continued investment in our team dedicated solely to providing physicians
with education and support for the MaterniT21 PLUS test, we expect that
Sequenom CMM will surpass the next milestone of accessioning 150,000 test
samples in 2013."
In response to the rapid volume growth and medical community adoption of the
MaterniT21 PLUS test, Sequenom CMM is in the process of increasing its testing
capacity by completing the validation and licensure of an additional location
in North Carolina. This additional location is expected to be operational in
the second half of 2013 and will increase the total NIPT capacity from the
current 200,000 test samples per year to a minimum of 300,000 test samples per
year. At the close of December 2012, the annualized run rate for the
MaterniT21 PLUS test was more than 120,000 test samples, an average of more
than 2,300 samples weekly.
The MaterniT21 PLUS LDT analyzes the relative amount of 21, 18, 13, as well as
X 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 CMM as
a testing service provided to physicians. To learn more about the test,
please visit www.Sequenomcmm.com.
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