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Verinata Health's verifi® Prenatal Test Expanded to Include Option to Test for Fetal Aneuploidy in Twin Pregnancies

Monday, October 14, 2013

Verinata Health's verifi® Prenatal Test Expanded to Include Option to Test for Fetal Aneuploidy in Twin Pregnancies

06:30 EDT Monday, October 14, 2013

REDWOOD CITY, Calif. (Business Wire) -- Illumina, Inc. (NASDAQ: 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.

About Verinata Health

Verinata (www.verinata.com), a wholly-owned subsidiary of Illumina, Inc., 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. We support national guidelines and the recent American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine Committee Opinion that recommend cell-free DNA prenatal testing as one option for use as a primary or secondary screening test in women at increased risk of aneuploidy. We believe women who desire such testing should be offered a single blood draw test with a definitive result. The verifi® prenatal test is available through a physician.

About Illumina

Illumina (www.illumina.com) is a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function. We provide innovative sequencing and array-based solutions for genotyping, copy number variation analysis, methylation studies, gene expression profiling, and low-multiplex analysis of DNA, RNA, and protein. We also provide tools and services that are fueling advances in consumer genomics and diagnostics. Our technology and products accelerate genetic analysis research and its application, paying the way for molecular medicine and ultimately transforming healthcare.

Forward-Looking Statements

This release may contain forward looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those in any forward-looking statements are detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We do not intend to update any forward-looking statements after the date of this release.

1 The verifi® prenatal test is a non-invasive blood test that analyzes DNA found in a pregnant woman's blood to detect chromosome abnormalities, including Down syndrome (trisomy 21 or T21), Edwards syndrome (trisomy 18 or T18), Patau syndrome (trisomy 13 or T13).

Illumina, Inc.
Investors:
Rebecca Chambers, 858-255-5243
rchambers@illumina.com
or
Media:
Jennifer Temple, 858-882-6822
pr@illumina.com

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