Illumina, Inc. has announced that the verifi® prenatal test, 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.