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

ConditionsPregnant Individuals Aneuploidy Down Syndrome (Trisomy 21)22q11.2 Deletion Syndrome Trisomy 13 Trisomy 18 Sex Chromosome Abnormalities

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

AgeNot listed

SponsorBillionToOne Inc.

About this trial

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

Qualifiers

pregnant individuals between 10 and 20 weeks of gestation

singleton gestation

Disqualifiers

None

Trial design

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants

are grouped into 2 trial groups

Locations

Arizona

Valley Perinatal Services85004, Phoenix United States

California

San Gabriel Valley Perinatal Medical Group91710, West Covina United States

Florida

Sarasota Memorial Health Care System34239, Sarasota United States

Georgia

Pediatrix Medical Group of Georgia30342, Atlanta United States

Sponsors and collaborators

BillionToOne Inc.

Lead sponsor

Source ClinicalTrials.gov