Blood test using fetal cells to check pregnancies for Down syndrome and other conditions
Tests a new blood test for fetal genetic conditions in pregnant people.
Key facts
- Who runs it
- BillionToOne Inc.
- Where
- Atlanta, Baton Rouge, Houston, New York, Phoenix, Riverside, Sarasota, and West Covina, United StatesSee the 9 sites
- Trial code
- Registry title
- 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
- Status
- Recruiting
- People taking part
- 1,000 people, planned
- Started
- 10 Jan 2026
- Expected to end
- Jun 2028
- Type of study
- Observational, 2 groups
- Record updated
- 15 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for pregnant people carrying one baby, between 10 and 20 weeks of pregnancy. It tests a new blood test that looks at baby cells in the mother's blood.
- Sex
- Female
- Disease stage
- Pregnant, between 10 and 20 weeks of pregnancy, carrying one baby (not twins or more).
Main reasons for not taking part
- Active cancer
- Pregnancy with more than one baby
This trial only enrols pregnant participants. The registry sentence this rests on: * pregnant individuals between 10 and 20 weeks of gestation
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- pregnant individuals between 10 and 20 weeks of gestation
- singleton gestation
Who cannot take part
- active cancer
Where in United States
- Pediatrix Medical Group of GeorgiaAtlanta, United StatesContact: Deena Yowler, NP, CNMTaking people
- Woman's HospitalBaton Rouge, United StatesContact: Bri Jones, MPHTaking people
- Pediatrix Medical GroupHouston, United StatesContact: Olaide Ashimi Balogun, MDTaking people
- UT Physicians Maternal-Fetal MedicineHouston, United StatesContact: Aarti Ramdaney, MS, CGCTaking people
- Carnegie Imaging for WomenNew York, United StatesContact: Josh LandoTaking people
- Valley Perinatal ServicesPhoenix, United StatesContact: Research DepartmentTaking people
- Brar PracticeRiverside, United StatesContact: Shelley Mueller, MS, CGCTaking people
- Sarasota Memorial Health Care SystemSarasota, United StatesContact: Scarleth Andino-Funez, BSN, RNTaking people
- San Gabriel Valley Perinatal Medical GroupWest Covina, United StatesContact: Richard Burwick, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- 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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- ADVANCE Study: Assay Development and Validation for Pre-Natal and Obstetric Conditions
- Plain-language title
- Blood test using fetal cells to check pregnancies for Down syndrome and other conditionsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 15 October 2026