Clinical Trial: Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: 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
Brief Summary: Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.
Detailed Summary:
Sponsor: Sequenom, Inc.
Current Primary Outcome: Clinical Assay Performance [ Time Frame: Performance of the assay will be based upon a single blood sample collected during the only study visit from a high risk pregnancy prior to the subject undergoing an invasive procedure (amniocentesis or CVS) to confirm fetal karyotype. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Subject selection bias assessment [ Time Frame: A single blood sample will be collected at a single clinic visit from high risk pregnancies that refuse to undergo an invasive procedure. ]
Original Secondary Outcome: Same as current
Information By: Sequenom, Inc.
Dates:
Date Received: February 15, 2012
Date Started: March 2012
Date Completion:
Last Updated: April 18, 2016
Last Verified: April 2016