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 (ADVANCE)

June 10, 2026 updated by: BillionToOne Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • Valley Perinatal Services
        • Contact:
        • Principal Investigator:
          • Nayo Williams, MD
    • California
      • West Covina, California, United States, 91710
        • Recruiting
        • San Gabriel Valley Perinatal Medical Group
        • Contact:
        • Principal Investigator:
          • Richard Burwick, MD
    • Florida
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Health Care System
        • Contact:
        • Principal Investigator:
          • Larry C Matsumoto, MD
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Pediatrix Medical Group of Georgia
        • Contact:
        • Principal Investigator:
          • Gretchen Koontz, MD
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70817
        • Recruiting
        • Woman's Hospital
        • Principal Investigator:
          • Elizabeth Sutton, PhD
        • Contact:
    • Texas
      • Houston, Texas, United States, 773339
        • Recruiting
        • Pediatrix Medical Group
        • Contact:
        • Contact:
          • Olaide Ashimi Balogun, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

pregnant individuals between 10 and 20 weeks of gestation with singleton pregnancies

Description

Inclusion Criteria:

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

Exclusion Criteria:

- active cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
High Risk
Pregnant individuals between 10 and 20 weeks of gestation with singleton pregnancies and who have a clinical indication for CFC testing, such as high-risk cfDNA results for common aneuploidies, copy number variants including 22q11.2, or sex chromosome aneuploidies
General Risk
Pregnant individuals between 10 and 20 weeks of gestation with singleton pregnancies (excluding gestational surrogates) who do not have a clinical indication for CFC and are undergoing prenatal diagnostic testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance
Time Frame: 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.
From enrollment and up to 12 months following enrollment
Concordance with the accepted method of diagnosis
Time Frame: 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.
From enrollment and up to 12 months following enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BillionToOne Inc.

Investigators

  • Principal Investigator: Julia Wynn, MS, MS, CGC, BillionToOne Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTO-IRB-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

CFC result and diagnostic testing result

IPD Sharing Time Frame

when data collection is complete and up to 2 years post-study completion date

IPD Sharing Access Criteria

Other researchers after the appropriate date use agreements are in place.

IPD Sharing Supporting Information Type

  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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