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Verinata Health’s verifi® Prenatal Test Available through the California Prenatal Screening Program

  Verinata Health’s verifi® Prenatal Test Available through the California
  Prenatal Screening Program

Business Wire

REDWOOD CITY, Calif. -- November 1, 2013

Illumina, Inc. (NASDAQ:ILMN) today announced that the verifi® prenatal test,^1
offered by Verinata Health, an Illumina company, will be available to pregnant
women in California through the state’s Prenatal Screening Program. The
availability of the verifi® prenatal test represents a major advance in
prenatal screening, providing pregnant women with genetic information about
their babies without the risk associated with invasive testing such as
amniocentesis or chorionic villus sampling (CVS).

Beginning today, all pregnant women in California at increased risk of
carrying a fetus with trisomy 21 (Down syndrome) or trisomy 18 (Edwards
syndrome), or who have had an ultrasound showing a large nuchal translucency,
will have the option of receiving a non-invasive prenatal test.

"As a designated prenatal diagnosis center, we evaluated all of the different
non-invasive prenatal tests, and selected the verifi® prenatal test based on
the fact it provides the fastest turnaround time at three to six days, the
lowest test failure rate at less than one percent, and an exceptionally
responsive staff," said Dr. Art Karimi, Director of the Institute of Prenatal
Diagnosis and Reproductive Genetics.

Women screening positive who desire a non-invasive prenatal test will be
referred to a designated state-approved Prenatal Diagnostic Center, many of
whom have elected to offer the verifi® prenatal test for their patients. The
California Prenatal Screening Program screens nearly 400,000 women annually
and is the largest prenatal screening program in the world.

"California is the first state to prioritize broad non-invasive prenatal
testing as a secondary screening option for high-risk pregnant women," said
Vance Vanier, M.D., Vice President of Global Commercial Operations for
Verinata. "We applaud the state of California for their leadership through
this comprehensive Prenatal Screening Program and we are pleased to bring
reliable results from the verifi® prenatal test to women throughout the
state."

The California Prenatal Screening Program is conducted through the state of
California Genetic Disease Screening Program. The voluntary Prenatal Screening
Program was established to provide pregnant women with improved screening for
genetic disorders. California offers the only comprehensive prenatal screening
program that includes follow-up for all non-negative test results,
non-invasive prenatal testing and/or confirmatory testing through either
amniocentesis or CVS, when indicated. In cases where a genetic disorder is
detected prenatally, managing the high-risk pregnancy and ensuring delivery in
a hospital with a Neonatal Intensive Care Unit with the appropriate level of
care provides optimal patient outcomes for these families.

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, paving 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) and sex chromosome abnormalities, and
can be used as early as 10 weeks of pregnancy.

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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