Illumina, Inc. ILMN today announced that Verinata Health, an
Illumina company, will offer a new test option for its non-invasive verifi®
prenatal test.^1 Physicians will now be able to use the verifi® prenatal test
for women pregnant with twins through natural or assisted reproductive
methods. The verifi® prenatal test for twins can detect trisomy 21 (Down
syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and the
presence of a Y chromosome in the fetuses.
“The verifi® prenatal test was validated using the largest twin population
study of over 100 maternal samples, more than any other NIPT method,” said
Richard Rava, Ph.D., Vice President of Research and Development for Verinata.
“We have incorporated new algorithms into the verifi® test to optimize
detection of aneuploidies. Unlike other methods available today, our
innovative approach to account for lower fetal fraction in twins ensures
accurate, reliable results and the industry's lowest test failure rate of 0.07
percent.”
Verinata validated its algorithms specifically for twins through an analysis
of 115 maternal plasma samples from twin pregnancies, with all instances of
aneuploidy detected. Of the 115 samples, the verifi® prenatal test with twins
option correctly detected all cases of Down syndrome (trisomy 21) and Edwards
syndrome (trisomy 18) in the samples, as well as all samples in which the
Y-chromosome was present.
“We continue to add functionality to the verifi® prenatal test, expanding the
test availability to new patient populations only after meeting our rigorous
scientific and clinical requirements,” said Jeff Bird, M.D., Ph.D., General
Manager of Verinata. “With the number of twin pregnancies increasing
significantly, we are pleased to offer a non-invasive alternative to detect
the most common fetal genetic abnormalities in women pregnant with twins.
Results from the verifi® prenatal test, for both singleton and twin
pregnancies, will continue to be returned to the physician within three to six
business days.”
In the United States, twins account for approximately 1 in 30 live births.
According to the National Center for Health Statistics, the rate of twins
increased 76 percent from 1980 to 2009. As women age, they are more likely to
release more than one egg per menstrual cycle and as such, women over 30
account for about one third of the increase in twin pregnancies. Assisted
reproduction techniques, where more than one embryo is often transferred into
the womb after in vitro fertilization, account for a majority of the remaining
increase in twin pregnancies.
The twins option for the verifi® prenatal test will be available through
physicians beginning October 21, 2013. For more information, visit
http://www.verinata.com/providers/twins.
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