2013-10-30 13:02:02 -
Natera, a leading innovator in prenatal genetic testing, and Médica Fértil today announced the birth of the first baby in Mexico whose mother was screened with Panorama™, Natera’s non-invasive prenatal test.
Panorama was launched in March 2013 for the detection of trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and monosomy X (Turner syndrome). Detection of triploidy was added to Panorama in October 2013.
"After many years of waiting, we are excited to finally be able to utilize in clinical practice the great advantages offered by the Panorama test for non-invasive prenatal testing,” said Rafael Sanchez, M.D., chief executive officer of Médica Fértil. “With the birth of the first baby in Mexico to be analyzed non-invasively
by the Panorama test, our country has entered into a new era in prenatal care. We are sure that this screening test will provide great benefits and peace of mind to many Mexican couples. For the patient, the Panorama test has provided much needed relief and she encourages all expecting mothers to take this test and benefit from the same sense of tranquility as she has.”
Added Matthew Rabinowitz, Ph.D., chief executive officer of Natera, “We are pleased to partner with Médica Fértil to bring Panorama to expecting parents in Mexico, and wish the best to the newborn baby and parents. It is our goal to continue expanding Panorama’s offerings for our partners worldwide so parents can receive the most accurate information possible, with the most applications, early in their pregnancies.”
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 NATUS [Next-generation Aneuploidy Testing Using SNPs] algorithm, an advanced version of Natera’s proprietary informatics.
About Médica Fértil
Médica Fértil is driven by a passion for helping couples realize the dream of parenthood. Its mission is to encourage couples from conception to the birth of a healthy baby. Always seeking the most advanced and accurate technologies in the world to offer to patients, Médica Fértil’s CEO, Dr. Rafael Sanchez has entered into collaboration with Natera, a leading American genetic testing laboratory with products ranging from preimplantation genetic diagnosis during IVF treatments to cutting-edge advances in the field of noninvasive prenatal diagnosis. With a focus on improved clinical outcomes, Médica Fértil offers its patients the newest, most reliable and most accurate technologies, based on advances in the human genome project and sophisticated bioinformatics. These technologies have revolutionized reproductive medicine, offering infertile couples significantly improved chances of achieving a successful pregnancy and world leading opportunities to analyze fetal DNA for chromosomal abnormalities in a non-invasive manner. Requiring only a maternal blood sample, these non-invasive technologies eliminate the possible risk of miscarriage associated with invasive procedures, providing patients with yet another tool to achieve a successful pregnancy.
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 : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..
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