NCT01555346

Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies

A Clinical Study to Evaluate the Clinical Performance of the SEQureDx Trisomy 21 Test in the Detection of the Relative Quantity of Chromosome 21 in Circulating Cell-Free DNA Extracted From a Maternal Blood Sample Obtained From Pregnant Women With One or More High Risk Indicators for Fetal Chromosome 21 Aneuploidy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,062 (actual)
• Sponsor: Sequenom, Inc. · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.

Conditions

• Down Syndrome
• Fetal Aneuploidy

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-10-01
• Completion: 2015-12-01
• First posted: 2012-03-15
• Last updated: 2016-04-20

Locations

29 sites across 2 countries: United States, Canada