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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

RECRUITINGSponsored by BillionToOne Inc.
Actively Recruiting
SponsorBillionToOne Inc.
Started2026-01-10
Est. completion2027-12
Eligibility
SexFEMALE
Healthy vol.Accepted
Locations6 sites
View on ClinicalTrials.gov →

NCT07643896

Summary

The goal of the ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) study is to compare the concordance of results of a novel non-invasive circulating fetal cell (CFC) assay to the results of prenatal invasive diagnostic testing or postnatal genetic and clinical diagnosis of the resulting neonate. This is a prospective study of pregnant individuals.

Eligibility

Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* pregnant individuals between 10 and 20 weeks of gestation
* singleton gestation

Exclusion Criteria:

\- active cancer

Conditions8

22q11.2 Deletion SyndromeAneuploidyDown Syndrome (Trisomy 21)Heart DiseasePregnant IndividualsSex Chromosome AbnormalitiesTrisomy 13Trisomy 18

Locations6 sites

Valley Perinatal Services
Phoenix, Arizona, 85004
Research Department480-756-6000research@valleyperinatal.com
San Gabriel Valley Perinatal Medical Group
West Covina, California, 91710
Richard Burwick, MD(626) 337-4425dr.burwick@sgvpmg.com
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
Scarleth Andino-Funez, BSN, RN941-917-2627Scarleth-AndinoFunez@smh.com
Pediatrix Medical Group of Georgia
Atlanta, Georgia, 30342
Deena Yowler, NP, CNM404-847-1592deena.yowler@pediatrix.com
Woman's Hospital
Baton Rouge, Louisiana, 70817
Bri Jones, MPH225-927-1300Briasha.Jones@womans.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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