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Ariosa Enrolling for Trial Comparing NGS-Based T21 Test to Standard First-Trimester Prenatal Screening

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Ariosa Diagnostics has begun enrolling average-risk women for a clinical study to compare its Harmony next-generation sequencing-based test with standard first-trimester combined screening for trisomy 21, Clinical Sequencing News has learned.

The purpose of the blinded multi-center prospective case-controlled study, which aims to enroll 25,000 women, is to compare Ariosa's test with the standard screening test, which is a combination of serum screening for PAPP-A and free beta-hCG or total hCG as well as a nuchal translucency measurement, in an average-risk population.

The trial, called NEXT for Non-Invasive Examination of Trisomy, will assess the performance characteristics of the two test modalities relative to the clinical reference standard of genetic analysis of the fetus or phenotypic characterization and genetic analysis of the newborn.

Cases will be patients with a trisomy 21 pregnancy confirmed by genetic testing, and controls will be patients without a trisomy 21 pregnancy, confirmed either by genetic testing or by a normal newborn phenotype.

The principal investigators of the study are Mary Norton, a professor of obstetrics and gynecology as well as maternal fetal medicine at the Stanford School of Medicine, and Ronald Wapner, professor of maternal-fetal medicine at Columbia University's department of obstetrics and gynecology.

The company is collaborating on the study with the Perinatal Quality Foundation's Nuchal Translucency Quality Review program. Earlier this year, the Maternal Fetal Medicine Foundation changed its name to become the Perinatal Quality Foundation.

More information about the study is available at ClinicalTrials.gov. According to the website, the study is estimated to be completed in July 2013.

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