Study shows non-invasive prenatal test performs reliably

Aug. 1, 2014

Natera, Inc., a leader in noninvasive genetic testing, has announced the results of a study published in the current issue ofObstetrics 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.

“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,” says Susan Gross, MD, chief medical officer for Natera.

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. Read the study abstract.

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