|[October 15, 2013]
Natera Selected as a 2013 Fierce 15 Device and Diagnostic Company
SAN CARLOS, Calif. --(Business Wire)--
Natera, a leading innovator in prenatal genetic testing, today announced
that it has been named by FierceMedicalDevices as a 2013 Fierce
15 device and diagnostic company, designating it as one of the most
promising private companies in the med tech space. This is FierceMedicalDevices'
second annual Fierce 15 selection.
In March 2013, Natera launched Panorama for the detection of trisomy 21
(Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau
syndrome) and monosomy X (Turner syndrome). It recently announced the
addition of triploidy detection to Panorama and improved turnaround time
of 7 to 10 calendar days. Natera has been a leader in genetic testing
since 2009 when it launched the world's first 24-chromosome PGD test
using SNPmicroarray, for families undergoing IVF treatment.
The Fierce 15 celebrates the spirit of being "fierce" - championing
innovation and creativity, even in the face of intense competition.
"These companies represent some of the best and brightest in the device
and diagnostics industries today," FierceMedicalDevices Editor
Damian Garde said. "They'll be producing big things in the months ahead."
Added Matthew Rabinowitz, Ph.D., chief executive officer of Natera, "We
are honored to receive this recognition from Fierce, one of the leading
publications in our industry. 2013 has been a tremendous year for Natera
as we grew to meet the demand of expecting parents who want the most
reliable information possible early in their pregnancies. We look
forward to continuing this growth in 2014 as we further expand the
capabilities of Panorama and our other innovative genetic tests."
Across multiple clinical trials, Panorama has been validated globally
for detection of trisomy 21, trisomy 18, trisomy 13, monosomy X, and now
triploidy, with a sensitivity of greater than 99 percent for trisomy 21,
trisomy 18, trisomy 13, and triploidy, 92 percent for monosomy X, and
specificity greater tan 99 percent for all syndromes tested. Panorama's
clinical validation data has been reported in multiple peer-reviewed
publications including the May 2013 article in Prenatal Diagnosis,
authored by Professor Nicolaides, which was the first demonstration of
Panorama's ability to detect triploidy. In October 2013 additional
validation data was published in Fetal Diagnosis and Therapy,
also authored by Professor Nicolaides, showing Panorama was able to
differentiate with high accuracy between triploid and euploid cases in
56 blinded samples.
Panorama uses a simple blood draw from the mother, examines cell-free
DNA originating from both mother and fetus found in maternal blood and
can be performed within the first trimester of pregnancy, as early as
nine weeks, without any risk to the fetus. Panorama's technology
analyzes, in a single reaction, 19,488 single nucleotide polymorphisms
(SNPs), which are the most informative portions of an individual's DNA.
It utilizes the NATUS [Next-generation Aneuploidy
Testing Using SNPs]
algorithm, an advanced version of Natera's proprietary informatics.
An internationally recognized newsletter reaching more than 30,000
medical device and diagnostics industry professionals, FierceMedicalDevices provides
subscribers with an authoritative analysis of the day's top stories.
Every year, FierceMedicalDevices evaluates dozens of private
companies from around the world for its annual Fierce 15 list, which is
based on factors including technology strength, partnerships, venture
backers and a competitive market position.
A complete list of "Fierce 15" companies - the online newsletter's
second annual selection - is available online at FierceMedicalDevices.com.
FierceMedicalDevices is the med tech industry's daily
monitor - a free email newsletter and web resource providing the latest
news, articles and resources related to M&A, clinical trials, FDA
approval and regulation, and more. Signing up is free.
Natera is a leading genetic testing company that has developed a
proprietary bioinformatics-based technology (NATUS) to deliver accurate
and comprehensive high-throughput testing for reproductive indications
from tiny quantities of DNA. Natera operates a CLIA-certified laboratory
in San Carlos, Calif., providing a host of preconception and prenatal
genetic testing services. Test offerings include pre-implantation
genetic diagnosis to identify chromosomal anomalies or inherited genetic
conditions in embryos generated during an IVF cycle;
products-of-conception testing following miscarriage to rapidly and
extensively analyze fetal chromosomes in order to understand the cause
of the pregnancy loss; non-invasive prenatal testing to determine
paternity; carrier screening tests to detect whether parents carry
genetic variations that may result in disease in the child; and
Panorama, a safe, simple test for pregnant women that identifies the
most common chromosomal anomalies in a fetus as early as nine weeks.
Natera's PreNATUS clinical trial for non-invasive screening of fetal
chromosomal anomalies is funded by the NIH and is being conducted by the
leaders in maternal-fetal medicine in the United States. For more
information, visit www.natera.com.
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