Development of a Fetal Sex Assay From Maternal Whole Blood
Development of a Fetal Sex Assay From Maternal Whole Blood
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