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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

Recruiting Observational Study
Pregnant Individuals Aneuploidy Down Syndrome (Trisomy 21) 22q11.2 Deletion Syndrome Trisomy 13 Trisomy 18 Sex Chromosome Abnormalities
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Sex
Female
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
BillionToOne Inc. · Industry
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About This Trial

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.

Trial Locations

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Eligibility Criteria
Inclusion Criteria: * pregnant individuals between 10 and 20 weeks of gestation * singleton gestation Exclusion Criteria: \- active cancer
Contacts

Shannon O'Rourke Senior Research Manager, MS, CGC

650-460-2551

unityregistry@billiontoone.com

CONTACT

NCT ID: NCT07643896 Source: ClinicalTrials.gov