Illumina, Inc. has 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.
Dr. Bird continued, “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.