NCT07643896
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Recruiting
Not specifiedAll AgesObservationalBillionToOne Inc.
~1,000 participants
Updated 2026-06-12 on ClinicalTrials.gov
At a glance
Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concordance
Measured over From enrollment and up to 12 months following enrollment
+1 more outcome measured
Conditions
Where it's being run
6 sites across 6 statesArizona1
California1
Florida1
Georgia1
Louisiana1
Texas1
Study leadership
- Julia Wynn, MS, MS, CGC · PRINCIPAL_INVESTIGATOR · BillionToOne Inc.
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
pregnant individuals between 10 and 20 weeks of gestation
singleton gestation
What this trial measures
- ConcordanceFrom enrollment and up to 12 months following enrollment
CFC results will be compared with prenatal diagnostic testing results, CVS, amniocentesis, products of conception, when available, and postnatal diagnostic testing.
- Concordance with the accepted method of diagnosisFrom enrollment and up to 12 months following enrollment
CFC results will be compared with prenatal diagnostic testing results, CVS, amniocentesis, products of conception, when available, and postnatal diagnostic testing. Results are considered concordant when CFC findings are consistent with the known or fetal or neonatal diagnosis.