Illumina's Verinata Health Reports Expanded Test of Verifi for Option to Test for Fetal Aneuploidy in Twin Pregnancies

Illumina, Inc.

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.