Clinical Trial: VAlidation of a Lower Cost aneUploidy scrEen

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational




Official Title: The VALUE Study - Women & Infants as the Coordinating Center

Brief Summary: This study will document the detection rate and false positive rate as well as failure rate of a new prenatal screening approach ('Smart NIPT') as described at www.vanadisdx.com and implemented in an academic laboratory with limited molecular testing experience. Testing will be performed on samples from a general risk pregnancy population, with additional high-risk cases added to improve confidence in the detection rate. Additional characteristics of this non-NGS test such as turn-around time, costs (equipment, training, per test), results reporting, fetal sex, fetal fraction, and quality measures will also be examined.