Development of a Fetal Sex Assay From Maternal Whole Blood

Development of a Noninvasive Fetal Sex Determination Test Between 6 and 16 Weeks of Gestation

Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test.

This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw will occur between 6 to 16 weeks of gestation. The fetal gender will be requested at or soon after delivery if fetal sex was not previously obtained by CVS or amniocentesis genetic analysis.

Inclusion Criteria:

• Subject is 18-64 years of age
• Subject is female
• Subject is pregnant and between 6 and 16 weeks of gestation
• Subject provides a signed and dated informed consent
• If subject undergoes a routine ultrasound between weeks 16 and 28, she agrees to provide the fetal sex results
• If subject undergoes an invasive procedure, she agrees to provide the fetal sex results

Exclusion Criteria:

• None