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Clinical Trials in the USA / NCT07643896
Recruiting Observational

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 · tracked via the Priya Life Science USA tracker
Sponsor
BillionToOne Inc
Phase
Observational
Started
2026-01-10
Last updated
2026-10-15

Condition(s) studied

Pregnant IndividualsAneuploidyDown Syndrome (Trisomy 21)22q11.2 Deletion SyndromeTrisomy 13Trisomy 18Sex Chromosome Abnormalities

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.

Eligibility

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * pregnant individuals between 10 and 20 weeks of gestation * singleton gestation Exclusion Criteria: \- active cancer

Primary outcome measure(s)

  • Concordance — From enrollment and up to 12 months following enrollment
    CFC results will be compared with prenatal diagnostic testing results, CVS, amniocentesis, products of conception, when available, and postnatal diagnostic testing.
  • Concordance with the accepted method of diagnosis — From enrollment and up to 12 months following enrollment
    CFC results will be compared with prenatal diagnostic testing results, CVS, amniocentesis, products of conception, when available, and postnatal diagnostic testing. Results are considered concordant when CFC findings are consistent with the known or fetal or neonatal diagnosis.

Trial sites (9)

FacilityCityRegionStatus
Valley Perinatal Services Phoenix Arizona Recruiting
Brar Practice Riverside California Recruiting
San Gabriel Valley Perinatal Medical Group West Covina California Recruiting
Sarasota Memorial Health Care System Sarasota Florida Recruiting
Pediatrix Medical Group of Georgia Atlanta Georgia Recruiting
Woman's Hospital Baton Rouge Louisiana Recruiting
Carnegie Imaging for Women New York New York Recruiting
UT Physicians Maternal-Fetal Medicine Houston Texas Recruiting
Pediatrix Medical Group Houston Texas Recruiting

Other trials for the same condition

Non-Euploid Embryo Transfer (NEET) Registry Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07643896 on ClinicalTrials.gov ↗ ← All trials in the USA