Verinata Health Publishes Clinical Laboratory Performance Data for verifi® Prenatal Test

  Verinata Health Publishes Clinical Laboratory Performance Data for verifi®
  Prenatal Test

    Demonstrates verifi® Is Highly Accurate in Detecting Fetal Chromosome
                                Abnormalities

Business Wire

REDWOOD CITY, Calif. -- April 25, 2013

Illumina, Inc. (NASDAQ: ILMN) today announced that Verinata Health, an
Illumina company, has published the first peer-reviewed study of non-invasive
prenatal test (NIPT) performance in a clinical laboratory setting. Data
collected from the first nine months of commercial availability confirmed that
Verinata’s verifi® prenatal test was in line with its published clinical
validation study published in the May 2012 issue of Obstetrics & Gynecology,
the official journal of the American College of Obstetricians and
Gynecologists. The verifi® prenatal test analyzes DNA found in a pregnant
woman’s blood to detect the most common chromosome abnormalities in the fetus.

“Professional societies have encouraged NIPT test providers to publish
unbiased commercial performance data in a peer-reviewed journal. This
publication demonstrates our commitment to transparency and continuous
improvement in the quality and monitoring of our verifi® test in the high risk
market,” said Dr. Jeffrey Bird, General Manager of Verinata Health. “We are
committed to providing customers with the best test performance in the
industry with regard to accuracy, rate of test failures, and turnaround time.”

Test Results in a Clinical Laboratory Setting

In the study published online today and forthcoming in the June issue of
Prenatal Diagnosis, Verinata Health tested 5,974 maternal blood samples.
Physicians received results of the verifi® test within an average of 5.1
business days, substantially faster than the industry standard. The test
failure rate was 0.7%, the lowest published test failure rate in the industry.
A low test failure rate reduces additional blood draws and test result delays.

Of the samples tested, the verifi® test detected aneuploidy in 284 (4.8%)
samples, a percentage consistent with the overall aneuploidy detection rate in
the high-risk pregnant population. Specifically, the verifi® test detected
trisomy 21 (Down syndrome) in 155 (2.6%) samples, trisomy 18 (Edwards
syndrome) in 66 (1.1%) samples, trisomy 13 (Patau syndrome) in 19 (0.3%)
samples, monosomy X (Turner syndrome) in 40 (0.7%) samples with cystic
hygroma, and four cases of double aneuploidy. Follow-up data were available
for 245 (86%) samples. For all results where aneuploidy is detected through a
verifi® test, Verinata Health recommends follow-up with a diagnostic procedure
(amniocentesis or chorionic villus sampling).

Five (0.08%) false negative cases were reported (two cases of trisomy 21, two
cases of trisomy 18 and one monosomy X). One of the trisomy 21 cases was
recently presented at the 2013 ACMG Annual Clinical Genetics meeting.
Additionally, 14 (0.2%) putative false positive sample results from the
verifi® test were not consistent with invasive procedure results or live birth
outcomes. As described in other case reports, these putative false positives
may actually result from complex underlying biological causes. Full results of
the study can be accessed here.

“Our initial commercial experience published today demonstrates that the
accuracy of the verifi® prenatal test is consistent with our large, blinded
prospective validation study, and we intend to publish additional performance
data as our test volumes continue to increase,” commented Richard Rava, Ph.D.,
Vice President of Research and Development at Verinata.

Product enhancements, corporate partnerships and positive payer coverage
decisions continue to drive demand for the verifi® prenatal test. In December
2012, Verinata introduced an expanded test menu that includes sex chromosome
abnormalities. In January 2013, Verinata signed an agreement with PerkinElmer,
Inc. to expand access to the verifi® prenatal test in the United States.

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 recommending cell-free DNA prenatal
testing is one option that can be used 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.

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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