Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies

Sequenom

Status: Completed

Conditions: Down Syndrome; Fetal Aneuploidy

Study type: Observational

Funder types: Industry

Identifiers

NCT01555346

SQNM-T21-304

Details and patient eligibility

About

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

Enrollment: 3,062 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant woman 18 years of age or older at 10 - 22 weeks gestation inclusive
• Subject has one or more high risk indicator for fetal chromosome 21 aneuploidy
• Subject provides signed and dated informed consent
• Subject agrees to provide a whole blood sample

Exclusion criteria

• Fetal demise at the time of the blood draw
• Previous specimen donation under this protocol

Trial design

3,062 participants in 2 patient groups

High risk pregnant subjects undergoing an invasive procedure

Description:

Women with one or more high risk factors for fetal chromosome 21 aneuploidy scheduled to undergo an invasive procedure for fetal karyotype determination.

High risk subjects electing not to undergo invasive procedure

Description:

Women with one or more high risk factors for fetal chromosome 21 aneuploidy who elect not to undergo an invasive procedure for fetal karyotype determination.