Automated Screen for Fetal Aneuploidy (FAST1)

BioCeryx

Status: Unknown

Conditions: Trisomy 21 and Other Fetal Aneuploidy

Treatments: Diagnostic Test: blood test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03635359

BCX 120

Details and patient eligibility

About

The purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening of fetal aneuploidy.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject is at least 18 years old and can provide informed consent;
2. Subject has a viable singleton or twin pregnancy;
3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;
4. Subject is planning to undergo chorionic villus sampling and/or amniocentesis for the purpose of genetic analysis of the fetus because of a suspected fetal chromosomal anomaly based on cell-free DNA test results, standard serum screening result, or fetal ultrasound abnormality.
5. OR the subject has already undergone chorionic villus sampling and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis.

Exclusion criteria

1. Subject (the mother) has known aneuploidy;
2. Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;
3. Subject has a fetal demise (including natural or elective reduction) identified prior to consent;
4. Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant.

Trial design

2,000 participants in 2 patient groups

positive for fetal aneuploidy

Treatment:

Diagnostic Test: blood test

negative for fetal aneuploidy

Treatment:

Diagnostic Test: blood test