Obstetrics & Gynecology (Green journal) published full data from Verinata Health’s prospective, blinded, multi-center clinical validation study to detect fetal chromosomal aneuploidies across the entire genome using its verifi prenatal test.
The publication, titled "Genome-Wide Fetal Aneuploidy Detection by Maternal Plasma DNA Sequencing," was selected as Editor's Choice of the peer-reviewed journal. Full study results are available in the online version, and a print version will be available in the May 2012 issue.
"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, CEO of Verinata Health. "The clinical study demonstrated 100% specificity (no false positives) in the most prevalent trisomies.”
Verinata's proprietary verifi non-invasive prenatal test will include the detection of Down syndrome (trisomy 21), Edwards syndrome (trisomy 18) and Patau syndrome (trisomy 13) in the initial launch configuration.
Additional technical papers covering Verinata's methods in practice and continuing improvement in sequencing results are pending.
The verifi prenatal test will be available to clinicians in the U.S. March 1 and will include simplified sample collection methods, streamlined test reporting and less than a 1% no call rate. Verinata intends to expand the capabilities of the verifi prenatal test later in 2012.