RecruitingNCT07643896

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

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


Sponsor

BillionToOne Inc.

Enrollment

1,000 participants

Start Date

Jan 10, 2026

Study Type

OBSERVATIONAL

Conditions

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: FEMALE

Inclusion Criteria2

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

Exclusion Criteria1

  • \- active cancer

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Locations(6)

Valley Perinatal Services

Phoenix, Arizona, United States

San Gabriel Valley Perinatal Medical Group

West Covina, California, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Pediatrix Medical Group of Georgia

Atlanta, Georgia, United States

Woman's Hospital

Baton Rouge, Louisiana, United States

Pediatrix Medical Group

Houston, Texas, United States

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NCT07643896


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