Non-invasive fetal cell test to check fetal chromosomal status in early pregnancy
Official title: ADVANCE Study: Assay Development and Validation for Pre-Natal and Obstetric Conditions
Run by BillionToOne Inc. · NCT07643896 · Data updated 2026-11-12
A large, non-invasive blood test in pregnant people between 10 and 20 weeks looks for fetal cells in the mother's blood to see if the baby has certain chromosomal conditions, comparing results to invasive or postnatal diagnoses.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 1000 (estimated) |
| Sponsor | BillionToOne Inc. Industry-sponsored |
| Locations | 9 sites (Phoenix, Arizona and 8 other locations) |
| Status | Recruiting |
| Started | January 10, 2026 |
| Main results expected | December 2027 |
| Study ends | June 2028 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07643896 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant individuals between 10 and 20 weeks of gestation with singleton pregnancies who are eligible and do not have active cancer.
✕Probably not a fit
Pregnant people outside the 10–20 week window, with multiple gestations, or with active cancer may not benefit as much from this test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The ADVANCE study examines a novel non-invasive circulating fetal cell (CFC) assay, UNITY Confirm, to determine fetal chromosomal status by analyzing intact fetal cells obtained from maternal blood. It enrolls singleton pregnancies between 10 and 20 weeks of gestation and aims to enroll over 1,000 participants. CFCs are captured and analyzed with cell-type markers and genotyping to distinguish fetal from maternal cells, enabling direct fetal CNV assessment. The study compares CFC results with standard prenatal diagnostic results or postnatal outcomes to evaluate concordance and potential clinical utility. This observational study builds on early-pregnancy biology to test whether CFC-based testing can offer an alternative to invasive procedures.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive option for early and accurate fetal chromosomal status assessment.
How similar studies have gone: Prior non-invasive cell-based approaches have shown promise but this study is among the larger prospective efforts focusing on circulating fetal cells.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * pregnant individuals between 10 and 20 weeks of gestation * singleton gestation Exclusion Criteria: \- active cancer
Where it's running
-
Valley Perinatal Services
Phoenix, Arizona, United States Recruiting -
Brar Practice
Riverside, California, United States Recruiting -
San Gabriel Valley Perinatal Medical Group
West Covina, California, United States Recruiting -
Sarasota Memorial Health Care System
Sarasota, Florida, United States Recruiting -
Pediatrix Medical Group of Georgia
Atlanta, Georgia, United States Recruiting -
Woman's Hospital
Baton Rouge, Louisiana, United States Recruiting
Show 3 more locations
-
Carnegie Imaging for Women
New York, New York, United States Recruiting -
UT Physicians Maternal-Fetal Medicine
Houston, Texas, United States Recruiting -
Pediatrix Medical Group
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Julia Wynn, MS, MS, CGC — BillionToOne Inc.
- Study coordinator: Shannon O'Rourke Senior Research Manager, MS, CGC
- Email: unityregistry@billiontoone.com
- Phone: 650-460-2551
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Two-week intensive brain-focused therapy program for children with neurodevelopmental and chromosomal conditions
This program will try a two-week, individualized multimodal neurorehabilitation approach for children about 4–12 years old with neurodevelopmental or chromosomal conditions to see if it improves attention, motor skills, communication, and daily functioning.
-
Gestational weight gain and outcomes after preconception GLP-1 receptor agonist use
This observational study looks to see if moms who used GLP-1 medications before pregnancy have different weight gain during pregnancy and pregnancy outcomes than those who didn’t use GLP-1 medications.
-
Vascular Health in Adults with Down Syndrome
This study tests how aging affects blood vessel function and stiffness in adults with Down syndrome compared with adults without Down syndrome.
-
Trust in people with intellectual disability: a look at Down syndrome and Fragile X syndrome
This study tests how people with Down syndrome or Fragile X syndrome process trust in social interactions to see how trust decisions differ in these groups.
-
AEF0217 for improving daily living and thinking in Down syndrome
This trial will test whether daily AEF0217 helps adolescents and adults with Down syndrome improve daily living skills, thinking, sleep, and quality of life.
-
Levetiracetam to prevent seizures in adults with Down syndrome and Alzheimer's disease
This trial will test whether the anti-seizure medicine levetiracetam can prevent tonic-clonic seizures and slow cognitive decline in adults over 40 who have Down syndrome and symptomatic Alzheimer's disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.