Annual Award by FierceMedicalDevices Recognizes Most Promising Private Companies in Med Tech Space
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 than 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 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 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 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.
Ian Stone, 619-308-6541
Solomon Moshkevich, 650-249-9090