NCT01597063

Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies

A Clinical Study to Evaluate the Relative Clinical Specificity Performance of the SEQureDx Trisomy Test in Pregnant Women at Low Risk for Fetal Chromosomal Aneuploidy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,333 (actual)
• Sponsor: Sequenom, Inc. · Industry
• Sex: Female
• Age: 18 Years – 34 Years
• Healthy volunteers: Not accepted

Summary

Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled. Study blood will be collected in the first or second trimester at a scheduled prenatal screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will be followed until delivery and the birth outcome recorded.

Conditions

• Aneuploidy
• Down Syndrome
• Noninvasive Prenatal Screening

Interventions

Type	Name	Description
DEVICE	SEQureDx Trisomy Test	Plasma samples obtained from maternal blood will be tested using the SEQureDx Trisomy Test, an in vitro diagnostic test that measures circulating cell-free fetal DNA. The test detects the relative quantity of chromosome 21, which is associated with trisomy 21.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-02-01
• Completion: 2015-12-01
• First posted: 2012-05-11
• Last updated: 2016-04-20

Locations

27 sites across 1 country: United States