Natera, a leading innovator in reproductive and prenatal genetic testing, today announced that the company's non-invasive prenatal screening test, Panorama, will launch on March 1 for the detection of trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and select sex chromosome abnormalities, such as monosomy X (Turner's syndrome).
In clinical validation studies, Panorama demonstrated a sensitivity of greater than 99% when detecting common chromosomal abnormalities such as trisomy 21, trisomy 18 and trisomy 13; and 92% when detecting monosomy X. In addition, Panorama demonstrated a specificity of 100% with no false positives for all the syndromes tested. The test uses fetal cell-free DNA found in maternal blood and works as early as nine weeks gestation. Panorama's clinical validation data was presented live at the annual Society of Maternal Fetal Medicine Meeting on February 15, 2013.
"We have spent several years refining our proprietary technology to bring the best screening test possible to expecting parents, and today we are proud to launch Panorama," said Matthew Rabinowitz, Ph.D., chief executive officer of Natera. "Our team's efforts have created a very reliable, yet safe non-invasive prenatal test that screens for common fetal chromosomal diseases and will be the first to screen for sex chromosome abnormalities in every sample. We also recognize that there is more potential for this technology in new areas, and we look forward to broadly extending the full benefits of Panorama's technology"
Professor Kypros Nicolaides, M.D., director of the Fetal Medicine Foundation and the Harris Birthright Research Centre for Fetal Medicine at King's College Hospital in London, added, "Cell-free DNA testing has already significantly advanced the level of care for expectant mothers. In our first study completed with Natera, I was pleased that the Panorama test was able to detect chromosomal abnormalities beyond trisomies 21, 18 and 13. I expect Panorama's new technology, based on SNPs, will have a positive impact on prenatal medicine."
Panorama's technology analyzes, in a single reaction, 19,500 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. Panorama has been validated globally and is currently being evaluated in several other clinical trials for the detection of genetic disorders, including trisomy 21, trisomy 18, trisomy 13, monosomy X, XXY, XYY, XXX and triploidy. The test uses a simple blood draw from the mother and can be performed within the first trimester of pregnancy, as early as 9 weeks, without any risk to the fetus.
Natera is a 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 9 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.
Source: Natera  via NewsEdge