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Recruiting NCT07643896

NCT07643896 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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Clinical Trial Summary
NCT ID NCT07643896
Status Recruiting
Phase
Sponsor BillionToOne Inc.
Condition Pregnant Individuals
Study Type OBSERVATIONAL
Enrollment 1,000 participants
Start Date 2026-01-10
Primary Completion 2027-12

Eligibility & Interventions

Sex Female only
Min Age N/A
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 1,000 participants in total. It began in 2026-01-10 with a primary completion date of 2027-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Shannon O'Rourke Senior Research Manager, MS, CGC

✉ unityregistry@billiontoone.com

📞 650-460-2551

Principal Investigator

Julia Wynn, MS, MS, CGC

PRINCIPAL INVESTIGATOR

BillionToOne Inc.

Frequently Asked Questions

Who can join the NCT07643896 clinical trial?

This trial is open to female participants only, studying Pregnant Individuals. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07643896 currently recruiting?

Yes, NCT07643896 is actively recruiting participants. Contact the research team at unityregistry@billiontoone.com for enrollment information.

Where is the NCT07643896 trial being conducted?

This trial is being conducted at Phoenix, United States, West Covina, United States, Sarasota, United States, Atlanta, United States and 2 additional locations.

Who is sponsoring the NCT07643896 clinical trial?

NCT07643896 is sponsored by BillionToOne Inc.. The principal investigator is Julia Wynn, MS, MS, CGC at BillionToOne Inc.. The trial plans to enroll 1,000 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: September 2026  ·  Data Methodology