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

ClinicalTrials.gov ID

NCT07643896

Lead Sponsor

BillionToOne Inc.INDUSTRY

Overall Status

Recruiting

Study Type

Observational

Enrollment

1,000Estimated

Last Update Posted

Jun 12, 2026Actual

Start Date

Jan 10, 2026Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Jun 2028Estimated

Official Title

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

Brief 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.

Detailed Description

BillionToOne Inc. is conducting a large prospective study to evaluate the performance of a non-invasive circulating fetal cell (CFC) assay. Circulating fetal cells, rare, intact trophoblast cells of placental origin present in maternal blood, offer a unique opportunity to directly analyze fetal genetic material without the need for invasive procedures. These cells are most abundant during the first trimester of pregnancy.

Building on this biology, the investigators developed a circulating fetal cell assay (UNITY Confirm) that isolates fetal-derived placenta cells from maternal blood and performs single-cell genomic analysis to assess chromosomal copy number. By combining cell-type-specific markers and genotyping to distinguish fetal from maternal cells, this approach enables direct evaluation of fetal chromosomal status, unlike cfDNA methods that rely on analysis of mixed DNA fragments.

This prospective study enrolls pregnant individuals between 10 and 20 weeks of gestation with singleton pregnancies and aims to include over 1,000 participants. CFC testing results are compared to prenatal or postnatal diagnostic outcomes.

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

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- active cancer

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

BillionToOne Inc.INDUSTRY

Briasha.Jones@womans.org225-927-1300

olaide.ashimibalogun@pediatrix.com346-616-2777

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