Natera, Inc., a leader in non-invasive genetic testing, today announced a study published in the August issue of Obstetrics and Gynecology, which demonstrates that the Panorama non-invasive prenatal test (NIPT) performs consistently well in all pregnant women, regardless of their prior risk level. This is the first major published study of Panorama that provides compelling scientific evidence for testing in the general population.
This study of more than 1,000 pregnant patients, half of whom were low risk, showed that Panorama’s false positive rate is less than 0.1% when screening for trisomies 21, 18, and 13. This false positive rate corresponds to a specificity of greater than 99.9%, which the authors found to be a statistically significant performance improvement over quantitative NIPT methods, made possible by Panorama’s unique ability to differentiate between maternal and fetal DNA.
"The results of this study reinforce the high accuracy and reliability of Panorama’s screening technology, and Natera’s focus on patient safety as the number one priority,” said Susan Gross, M.D., chief medical officer for Natera. “We expect that this study, when combined with the growing body of evidence in the scientific literature, will give the medical community added comfort that Panorama works equally well in all pregnant women and would reduce the number of unwanted invasive procedures that result from other screening methods.”
NIPT, based on analyzing cell-free fetal DNA circulating in maternal blood, was initially recommended for use in the high-risk pregnant population — typically pregnant women 35 years of age or older or pregnant women who carry some other known risk for a fetal chromosomal disorder. This recommendation for testing only in the high-risk population was largely due to a lack of sufficient data about test performance in lower risk pregnancies, which this study from Natera is meant to address. Natera is helping to enable change through its leadership in scientific research, designing and conducting studies to demonstrate efficacy and clinical utility in the general population.
The results of this study, entitled "SNP-based Non-invasive Prenatal Screening in a High-risk and Low-risk Cohort,” by lead authors Dr. Eugene Pergament and Dr. Howard Cuckle, are available online and in the August issue of Obstetrics and Gynecology.
Natera is a genetic testing company that designs targeted assays to analyze tiny quantities of DNA. The mission of the company is to help families diagnose and manage genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif., currently offering a host of preconception and prenatal genetic testing services primarily to OBGYN physicians and in-vitro fertilization centers. In 2013, the company launched Panorama™, a safe, simple test for pregnant women that screens for the most common chromosomal anomalies in a fetus as early as nine weeks of gestation. Tests developed by Natera have not been cleared or approved by the U.S. Food and Drug Administration (FDA). For more information, visit www.natera.com.
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Mike Hromadik, 858-442-2215