Verinata Health Receives New York State Laboratory Permit for verifi® Prenatal Test

  Verinata Health Receives New York State Laboratory Permit for verifi®
  Prenatal Test

Business Wire

REDWOOD CITY, Calif. -- August 1, 2013

Illumina, Inc. (NASDAQ: ILMN) today announced that Verinata Health, an
Illumina company, received the Clinical Laboratory Permit from the New York
State Department of Health for its CLIA-certified, CAP-accredited laboratory.
The verifi® prenatal test, a non-invasive blood test that analyzes DNA found
in a pregnant woman’s blood to detect the most common chromosomal
abnormalities in the fetus, is now generally available in all 50 states.

“As the first non-invasive prenatal test (NIPT) provider to receive this
important certification, we can now actively serve the growing interest and
demand for non-invasive prenatal testing in New York,” said Dr. Jeffrey Bird,
General Manager of Verinata. “This milestone underscores our commitment to the
highest quality of testing and I’m pleased that Verinata continues to deliver
the fastest turnaround time with the lowest test failure rate available to
physicians and patients today.”

The clinical laboratory evaluation and validation process required to receive
New York’s Clinical Laboratory Permit is designed to ensure accurate, reliable
clinical laboratory services. This process is considered to be among the most
rigorous quality control standard in the country. The permit allows all
physicians residing in the state of New York the ability to recommend the
verifi® prenatal test to patients at high-risk of having a child with a
chromosomal abnormality such as Down syndrome.

About the verifi® prenatal test

The verifi® prenatal test analyzes genetic material (or DNA) naturally found
in a pregnant woman’s blood to detect Down syndrome (trisomy 21 or T21),
Edwards syndrome (trisomy 18 or T18), Patau syndrome (trisomy 13 or T13) and
sex chromosome abnormalities in the fetus. When directed by a physician, the
verifi® prenatal test can be offered to a pregnant woman of at least 10 weeks
gestation at high risk of carrying a fetus with a genetic abnormality. A
physician may classify a woman as “high-risk” if she is over 35 years of age,
has a prior personal or family history of chromosome abnormalities, or has had
a positive initial screening test indicating she is at increased risk for
carrying a fetus with a genetic abnormality.

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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