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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

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NCT07643896 · readout ≤ 498 d

Sponsored by BillionToOne Inc. (industry) · BLLN — their whole pipeline →.

Phase
Status
Recruiting
Study type
Observational
Enrollment
1,000estimated
Sites
6
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2026-01-10actualWhen the study began enrolling
Primary completionDec 2027estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionJun 2028estimatedThe whole study's end, after follow-up
First posted2026-06-12actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-06-12actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

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

Primary outcomes

what the primary-completion date above is the date OF
Concordance
measured From enrollment and up to 12 months following enrollment
Concordance with the accepted method of diagnosis
measured From enrollment and up to 12 months following enrollment

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