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 testThe 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.