Verinata Health Inc. (Redwood City, CA) has launched a non-invasive prenatal test that can detect fetal chromosomal abnormalities early in a pregnancy using maternal plasma. The test uses DNA sequencing to detect fetal chromosomal aneuploidies such as Down syndrome (trisomy 21), Edwards syndrome (trisomy 18), and Patau syndrome (trisomy 13). According the the company, its test has better accuracy than maternal serum screening tests currently available.
Verinata recently announced that it has completed a clinical study that supports the accuracy of the test. An article based on the study will be highlighted in an upcoming issue of Obstetrics & Gynecology.
From the company’s announcement:
“When we designed this study, it was imperative that it emulate actual clinical practice, including all high risk pregnant women, and importantly, detecting aneuploidy across the entire genome, where the genetic information about the fetus is unknown prior to this test,” said Caren L. Mason, chief executive officer of Verinata Health. “The clinical study demonstrated 100% specificity (no false positives) in the most prevalent trisomies. We will work with maternal fetal medicine specialists, ObGyns and genetic counselors to incorporate our verifi™ prenatal test into clinical practice, offering a non-invasive choice to accurately detect the three major fetal autosomal chromosome aneuploidies. We are thrilled to have the full publication broadly available to readers to support the launch of the verifi™ prenatal test.”
The company expects to improve the capabilities of the prenatal test later in 2012..
Link: Verinata Health…
Abstract: Genome-Wide Fetal Aneuploidy Detection by Maternal Plasma DNA Sequencing…
Press release: Verinata Announces Peer-Reviewed Manuscript in Obstetrics & Gynecology (The Green Journal), the Official Publication of the American College of Obstetricians and Gynecologists