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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 AgesObservational
BillionToOne 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

Pregnant Individuals
Aneuploidy
Down Syndrome (Trisomy 21)
22q11.2 Deletion Syndrome
Trisomy 13
Trisomy 18
Sex Chromosome Abnormalities

Explore related trials

22q11.2 Deletion Syndrome5p13 microduplication syndromeAneuploidyDown SyndromePregnancySex Chromosome AbnormalitiesTrisomy 18 Syndrome18q22q11.2Chromosome 13Chromosome 21Sex Chromosome

NCT07643896

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Pediatrix Medical Group

    Houston, Texasstudy coordinator listed

    Recruiting

  • Pediatrix Medical Group of Georgia

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • San Gabriel Valley Perinatal Medical Group

    West Covina, Californiastudy coordinator listed

    Recruiting

  • Sarasota Memorial Health Care System

    Sarasota, Floridastudy coordinator listed

    Recruiting

  • Valley Perinatal Services

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • Woman's Hospital

    Baton Rouge, Louisianastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Julia Wynn, MS, MS, CGC · PRINCIPAL_INVESTIGATOR · BillionToOne Inc.

Who to contact

Shannon O'Rourke Senior Research Manager, MS, CGC
[email protected]
650-460-2551
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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.