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Last updated on April 19, 2014 at 1:20 EDT

Verinata Health Expands verifi(TM) Prenatal Test To Include Turner Syndrome Option

July 2, 2012

REDWOOD CITY, Calif., July 2, 2012 /PRNewswire/ — Verinata Health, Inc., a privately-held company dedicated to maternal and fetal health, today announced that its non-invasive verifi(TM) prenatal test can now be used to detect Turner syndrome (monosomy X or XO), a genetic condition in which a person has one X chromosome and is missing a second sex chromosome. Turner syndrome affects approximately one in every 2,000 female births.

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Verinata is launching the Monosomy X option, a test for Turner syndrome, as an optional addition to the verifi(TM) prenatal test. The verifi test is a non-invasive prenatal test designed to detect Down syndrome (trisomy 21), Edwards syndrome (trisomy 18) and Patau syndrome. The Monosomy X option may be ordered for patients with cystic hygroma, an ultrasound finding which suggests that the fetus has an increased risk of having an abnormal number of chromosomes. The verifi test is available for all pregnant women determined to be high risk by their physician.

In clinical studies performed by Verinata, two-thirds of fetuses with an ultrasound finding of cystic hygroma were confirmed to have chromosomal abnormalities, with ninety percent identified as Down, Edwards, Patau or Turner syndromes. Turner syndrome is the second most common chromosomal disorder for patients with a finding of cystic hygroma.

“Building on a clinical analysis of cystic hygroma data from our large, comprehensive validation study across the genome, we are able to expand the functionality of our verifi prenatal test for physicians and their patients,” said Dr. Jeffrey Bird, Executive Chairman and CEO of Verinata Health. “Until now, the only way to positively diagnose Turner syndrome was through invasive testing such as amniocentesis or chorionic villus sampling (CVS), both of which pose a risk to the fetus. We believe the verifi test with the Monosomy X option presents a safer, non-invasive alternative for the detection of Turner syndrome.”

The verifi(TM) Monosomy X option can be used to detect Turner syndrome in singleton pregnancies after an ultrasound exam identifies a cystic hygroma. In clinical studies, the verifi Monosomy X option detected 19/20 cases of Turner syndrome (95 percent sensitivity) with no false positives (54/54, 100 percent specificity).

About Turner Syndrome (Monosomy X)

Turner syndrome is a condition that affects primarily females. Also known as monosomy X, Turner syndrome results when one X chromosome is present but the other sex chromosome is missing. Turner syndrome causes a variety of physical differences, including wide and webbed neck, swollen hands and feet, incomplete development at puberty, lack of menses, kidney anomalies and congenital heart defects, though the severity differs greatly among affected individuals. If a congenital heart defect is detected, this often requires planning at birth. In addition, if diagnosed early, therapies can be administered to encourage normal development.

Verinata Health, Inc.

Verinata is driven by a sole, extraordinary purpose – maternal and fetal health. Our initial focus is to develop and offer non-invasive tests for early identification of fetal chromosomal abnormalities using our proprietary technologies. We aim to reduce the anxiety associated with today’s multi-step process, the unacceptable false-positive rates, the non-specific and sometimes confusing results of current prenatal screening methods, as well as the risk of current invasive procedures. In support of national guidelines recommending first trimester aneuploidy risk assessment, we believe women who desire such an assessment should be offered a single blood draw test with a definitive result. The verifi(TM) prenatal test and verifi(TM) Monosomy X option are available throughout the United States, with the exception of New York, through a physician. For more information about Verinata, please go to www.verinata.com.

SOURCE Verinata Health, Inc.


Source: PR Newswire