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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

RecruitingObservational study

ADVANCE Study: Assay Development and Validation for Pre-Natal and Obstetric Conditions

Who can join

All ages · Women

Full eligibility criteria
Inclusion Criteria:

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

Exclusion Criteria:

\- active cancer

About the study

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.

Sponsor: BillionToOne Inc. · Participants: 1,000 · Started: Jan 10, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07643896

Locations in the U.S.

ArizonaValley Perinatal Services, Phoenix
CaliforniaSan Gabriel Valley Perinatal Medical Group, West Covina
FloridaSarasota Memorial Health Care System, Sarasota
GeorgiaPediatrix Medical Group of Georgia, Atlanta
LouisianaWoman's Hospital, Baton Rouge
TexasPediatrix Medical Group, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.