Validation Data Presented by Natera Demonstrates Best-in-Class Specificity and Sensitivity of Non-Invasive Prenatal Test Panorama™
Data Presented at Society for Maternal-Fetal Medicine Annual Meeting
Natera today announced the presentation of validation data demonstrating unmatched specificity and sensitivity of the company's non-invasive prenatal test, Panorama(TM). The presentation, titled "Use of targeted sequencing of SNPs to achieve a highly accurate non-invasive detection of fetal aneuploidy of 13, 18, 21, and sex chromosomes," is being delivered at the annual meeting of the Society for Maternal-Fetal Medicine in San Francisco.
The data presented is from a clinical trial evaluating Panorama's efficacy in detecting chromosomal abnormalities from fetal cell-free DNA found in maternal blood as early as nine weeks gestation. In 764 maternal blood samples, Panorama demonstrated a sensitivity of greater than 99% when detecting common chromosomal abnormalities such as trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and 92% when detecting monosomy X (Turner's syndrome). In addition, Panorama demonstrated a specificity of 100% with no false positives for all the syndromes tested.
"Every set of data we have received from clinical studies of Panorama reinforce our long-held belief that this test can offer patients the most reliable information consistently across multiple chromosomal abnormalities," said Matthew Rabinowitz, Ph.D., chief executive officer of Natera. "Following a successful soft launch in late 2012, we are taking the final steps for our global launch of this test. Panorama uniquely targets, in a single reaction, 19,500 SNPs (single nucleotide polymorphisms), which are the most informative pieces of an individual's DNA and we look forward to advancing this technology and improving the care of pregnancies globally."
Added Harbinder Brar, M.D., a specialist in maternal/fetal medicine and genetics and medical director of the Prenatal Diagnostic and Perinatal Center in Riverside and San Bernardino who was involved in the study, "This study showed that Panorama had no false positives, which provides women with the confidence that they can rely on their test results, an extremely important quality when receiving information about the health of a fetus. These results continue to establish Panorama's strong predictive value as one of the best among NIPTs currently available and this test will offer women a reliable, highly accurate testing option when choosing prenatal care."
Panorama utilizes Next-generation Aneuploidy Testing Using SNPs, an advanced version of Natera's proprietary algorithm. Panorama has been validated in the United States and in Europe and is currently being evaluated in several other clinical trials for detection of genetic disorders, including trisomy 21, trisomy 18, trisomy 13, monsomy X, XXY, XYY, XXX and triploidy. The test, which is currently offered through a subset of early access clinics, uses a simple blood draw from the mother and can be performed within the first trimester of pregnancy without any risk to the fetus.
Natera is a genetic testing company that has developed a proprietary bioinformaticsbased technology to deliver accurate and comprehensive highthroughput 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 preimplantation 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 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, 619-308-6540
Gautam Kollu, 650-249-9090