REDWOOD CITY, Calif.--(BUSINESS WIRE)--Nov. 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.
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