Recruiting

Fetal Cell Assay

Sponsor:

BillionToOne Inc.

Code:

NCT07643896

Conditions

Pregnant Individuals

Aneuploidy

Down Syndrome (Trisomy 21)

22q11.2 Deletion Syndrome

Trisomy 13

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Pregnant Individuals

Aneuploidy

Down Syndrome (Trisomy 21)

22q11.2 Deletion Syndrome

Trisomy 13

Study ID

NCT07643896

Start date

Jan 10, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

\- active cancer

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Concordance [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Shannon O'Rourke Senior Research Manager, MS, CGC

650-460-2551unityregistry@billiontoone.com

Locations

Valley Perinatal Services

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Research Department

480-756-6000research@valleyperinatal.com

Principal Investigator:

Nayo Williams, MD

San Gabriel Valley Perinatal Medical Group

Recruiting

West Covina, California, United States, 91710

Contacts

Richard Burwick, MD

(626) 337-4425dr.burwick@sgvpmg.com

Principal Investigator:

Richard Burwick, MD

Sarasota Memorial Health Care System

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Scarleth Andino-Funez, BSN, RN

941-917-2627Scarleth-AndinoFunez@smh.com

Principal Investigator:

Larry C Matsumoto, MD

Pediatrix Medical Group of Georgia

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Deena Yowler, NP, CNM

404-847-1592deena.yowler@pediatrix.com

Principal Investigator:

Gretchen Koontz, MD

Woman's Hospital

Recruiting

Baton Rouge, Louisiana, United States, 70817

Contacts

Bri Jones, MPH

225-927-1300Briasha.Jones@womans.org

Principal Investigator:

Elizabeth Sutton, PhD

Pediatrix Medical Group

Recruiting

Houston, Texas, United States, 773339

Contacts

Olaide Ashimi Balogun, MD

346-616-2777olaide.ashimibalogun@pediatrix.com

More Information

Sponsor

BillionToOne Inc.

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • pregnant
  • aneuploidy
  • NIPT
  • NIPS
  • circulating fetal cell

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BillionToOne Inc. on 2026-06-12.