Automated Screen for Fetal Aneuploidy

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.