Press release from Business Wire
Verinata Health Receives New York State Laboratory Permit for verifi® Prenatal Test
Thursday, August 01, 2013
Verinata Health Receives New York State Laboratory Permit for verifi® Prenatal Test20:15 EDT Thursday, August 01, 2013
REDWOOD CITY, Calif. (Business Wire) -- 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.
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.
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.