SAN CARLOS, Calif.--()--Natera presented additional data from an ongoing clinical study of the company’s non-invasive prenatal screening test that demonstrates consistently high detection of chromosomal abnormalities from fetal cell-free DNA found in maternal blood. The data were presented in a poster presentation at the annual meeting of the American Society of Human Genetics in San Francisco on Thursday, November 8.
“In addition, we are very pleased that the latest redraw rate produced by the NATUS algorithm is considerably below those in the industry who have tried to achieve comparable coverage. We will continue to make improvements to our test as we prepare it for clinical use.”
The presented data, obtained from 407 maternal blood samples, demonstrated 100 percent specificity and sensitivity when detecting aneuploidies of five specific chromosomes. The study tested for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and sex chromosome abnormalities, such as monosomy X (Turner’s syndrome). The study was conducted using NATUS [Next-generation Aneuploidy Testing Using SNPs], an advanced version of Natera’s algorithm.
“Our clinical data continues to demonstrate that we are the first non-invasive prenatal test that can provide expectant parents with accurate results across multiple chromosomes, including detection of sex chromosome abnormalities, as early as nine weeks of pregnancy,” said Matthew Rabinowitz, Ph.D., chief executive officer of Natera. “In addition, we are very pleased that the latest redraw rate produced by the NATUS algorithm is considerably below those in the industry who have tried to achieve comparable coverage. We will continue to make improvements to our test as we prepare it for clinical use.”
Natera’s non-invasive prenatal test is currently being evaluated in multiple clinical trials for detection of multiple disorders, including trisomy 13, trisomy 18, trisomy 21, XXY, XYY, XXX and monosomy X. The test, which will be offered in a subset of early access clinics this year, 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’s PreNATUS clinical trial is the first clinical trial of a non-invasive prenatal test that is funded in part by the National Institutes of Health.
Natera is a genetic testing company that has developed a proprietary bioinformatics-based technology (Parental SupportTM) to deliver accurate and comprehensive high-throughput testing for reproductive indications from tiny quantities of DNA – as small as that from a single cell. 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 in order to select those with the highest probability of becoming healthy children; products-of-conception testing following miscarriage to rapidly and extensively analyze fetal chromosomes in order to understand the cause of the pregnancy loss; and non-invasive prenatal testing to determine paternity or detect whether parents carry genetic variations that may result in disease in the child by analyzing fragments of fetal cell-free DNA in a pregnant mother’s blood drawn as early as the first trimester. Non-invasive testing for paternity is currently available worldwide. Natera's PreNATUS clinical trial for non-invasive detection 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.