As Down syndrome becomes an increasing concern, Aria Diagnostics is launching a comparative study of a non-invasive prenatal test to detect Trisomy 21 (associated with Down synrome) and the standard first-trimester screening test.
Currently in development, Aria’s test is a directed, non-invasive approach to cell-free DNA analysis in maternal blood for evaluation of common fetal trisomies linked to genetic disorders.
The comparative, multicenter clinical trial will enlist 25,000 women, age 18 years or older, who are pregnant with one fetus and planning a hospital delivery. Blood samples will be collected between 10 and 14 weeks, and those receiving the standard first-trimester screening will also receive a nuchal translucency measurement performed via ultrasound. The trial will gather information throughout the pregnancies and collect newborn medical records following birth.
In addition to comparing the performance characteristics of Aria's test with standard first-trimester screening for Trisomy 21, the NEXT (Non-Invasive Chromosomal Examination of Trisomy) study will help define the optimal clinical testing practice for first trimester testing.
The trial is the largest clinical study ever to directly compare first-trimester prenatal testing options.