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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

NCT07643896 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-06-12

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • BillionToOne Inc.

    lead INDUSTRY

Principal Investigators

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

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-10
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07643896 on ClinicalTrials.gov