Fetal Cell Analysis From Maternal Blood

Validation of a Cell-Based Technology for Non-Invasive-Prenatal-Diagnosis (CB-NIPD) Using Circulating Whole Fetal Cells From Maternal Peripheral Blood.

The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.

Inclusion Criteria:

• Participant has a viable singleton or twin pregnancy
• Women who have already been selected by their treating physician to undergo an invasive fetal diagnostic procedure
• Participant is at least 18 years old and can provide informed consent

Exclusion Criteria:

• Unable to provide informed consent
• Prenatal diagnosis of clinical Chorioamnionitis
• Intake of drugs or exposure to teratogenic agents
• Infections that carry a risk of vertical transmission
• Known maternal viral diseases: HIV and HCV, HBV