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

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

Business Wire

REDWOOD CITY, Calif. -- October 14, 2013

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).

Contact:

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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