Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies

Sequenom

Status: Completed

Conditions: Aneuploidy; Down Syndrome; Noninvasive Prenatal Screening

Treatments: Device: SEQureDx Trisomy Test

Study type: Observational

Funder types: Industry

Identifiers

NCT01597063

SQNM-T21-303

Details and patient eligibility

About

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.

Enrollment: 3,333 patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnancy is 10-22 weeks gestation
• Between 18-34 years of age inclusive at estimated date of delivery
• No prenatal screening indicators for high risk including serum biochemical and ultrasound screening
• No personal or family history of Down syndrome
• Willing to provide written informed consent
• Willing to provide a whole blood sample
• Willing to provide access to medical records supporting fetal outcome

Exclusion criteria

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

Trial design

3,333 participants in 1 patient group

low risk pregnancies

Treatment:

Device: SEQureDx Trisomy Test