Natera, Inc., a leading innovator in prenatal genetic testing, today
announced that it has received a new conditional approval from the New
York State Department of Health to offer its Panorama™ non-invasive
prenatal test (NIPT) for aneuploidies and 22q11.2 deletion syndrome in
all pregnant women.
"This conditional approval marks another major milestone for Natera, and
it reflects the strength of Natera's validation methodology," said
Matthew Rabinowitz, Ph.D., chief executive officer of Natera. "We are
encouraged by the rapid adoption of microdeletion screening since its
release in March, and we are pleased that expecting parents in New York
will now have access to the latest prenatal testing technology."
The Panorama test is a safe, non-invasive prenatal screening tool that
uses a blood sample to assess the risk of certain chromosomal conditions
that may affect a baby's health. Panorama can safely and accurately
screen for many genetic conditions, including Down syndrome, Edwards
Syndrome and Patau syndrome; and as of March 2014, it was expanded to
screen for five microdeletions. Microdeletions are tiny missing pieces
of DNA at the sub-chromosomal level, which can haveserious health
implications depending on the location of the deletion.
22q11.2 deletion syndrome (also known as DiGeorge syndrome or "22q") is
the most common microdeletion on Panorama's screening panel, affecting
approximately 1 out of every 2,000 births regardless of maternal age at
time of pregnancy. The syndrome can cause heart defects, growth delays,
immune system and endocrine issues, developmental and speech delays, and
behavioral, emotional and psychiatric challenges. There is no cure for
22q, though early identification and medical intervention helps to
address associated symptoms.
The Panorama test is currently the only commercially-available NIPT that
uses a SNP-based approach to detect chromosomal abnormalities, delivering
a result early in pregnancy that is highly accurate across fetal
fractions. The test uses a simple blood draw from the mother as early as
nine weeks gestation. Panorama has been validated in multiple clinical
trials and is the only commercially available NIPT to consistently
demonstrate high sensitivity and specificity for several major
aneuploidies beyond Down syndrome, including trisomy 13 and 18, monosomy
X (Turner syndrome), and triploidy (Triploidy syndrome).
Natera, Inc. is a genetic testing company that specializes in analyzing
microscopic quantities of DNA for reproductive health. The mission of
the company is to help families conceive and deliver. In pursuit of that
mission, Natera operates a laboratory certified under the Clinical
Laboratory Improvement Amendments (CLIA) in San Carlos, Calif.,
providing a host of preconception and prenatal genetic testing services
primarily to OBGYN physicians and in-vitro fertilization centers. In
early 2013, the company launched Panorama™, a safe, simple test for
pregnant women that screens for the most common chromosomal anomalies in
a fetus as early as nine weeks of gestation. These tests were developed
by Natera, and they have not been cleared or approved by the U.S. Food
and Drug Administration (FDA). For more information, visit www.natera.com.
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