Study Demonstrates High Rates of Fetal Trisomy 21 and Trisomy 18 Detection with Low False Positive Rates
San Jose, Calif., June 4, 2012 – Ariosa Diagnostics, Inc., a molecular diagnostics company, announced the publication of its NICE (Non-Invasive Chromosomal Evaluation) Study, an international multicenter prospective, cohort study of more than 4,000 pregnant women at gestational age 10 weeks or later from 50 clinical sites. The study evaluated Harmony Prenatal Test’s performance in detecting fetal Trisomy 21 and 18, which cause Down syndrome and Edwards syndrome respectively.
“The NICE Study is unique from other non-invasive prenatal clinical studies conducted to date,” stated Mary E. Norton, MD, director of perinatal research, Lucile Packard Children's Hospital at Stanford University, and lead author of the study. “With this study, we evaluated all pregnant women who underwent invasive testing regardless of trisomy risk with the Harmony test. The encouraging results from this study lend further support for non-invasive prenatal testing to be used in clinical care.”
Published online in the American Journal of Obstetrics and Gynecology http://www.sciencedirect.com/science/article/pii/S0002937812005844?v=s5, the study evaluated all eligible subjects with the Harmony Prenatal Test. With the Harmony test, all 81 Trisomy 21 cases and 37 of 38 Trisomy 18 cases were classified as High Risk. The false positive rate was less than 0.1% for each of the trisomies.
“With four separate studies published this year, Ariosa is setting a high clinical standard for peer reviewed analysis of cell free detection methodologies,” said Thomas Musci, MD, vice president of clinical development and medical affairs for Ariosa Diagnostics. “Our clinical data highlight the accuracy of the Harmony test as well as the advantages of our directed analysis of cell-free DNA.”
The NICE study announcement coincides with the full scale product launch of the Harmony Prenatal Test through Laboratory Corporation of America Holdings (LabCorp) and Integrated Genetics. Through an extensive network of 1000+ patient service centers, the Harmony Prenatal Test is widely accessible for patient testing when ordered by healthcare providers.
The Harmony Prenatal Test is performed using a simple maternal blood draw and detects fetal trisomy via analysis of cell-free DNA in maternal blood.