BillionToOne Launches Unity Confirm With 100% Diagnostic Concordance
Unity Confirm is a non-invasive prenatal confirmation test that isolates intact circulating fetal cells via BillionToOne’s Fetal Cell Capture™ technology, delivering whole-genome sequencing results with 100% concordance across 16 high-risk samples. It launches May 28 for Unity Aneuploidy users and is enrolling 1,000 patients in a prospective study.
1. Launch Details
BillionToOne will make Unity Confirm available on May 28 to providers using its Unity Aneuploidy prenatal screen, enabling non-invasive confirmation of high-risk results from a single maternal blood draw.
2. Technology Overview
Unity Confirm uses Fetal Cell Capture™ technology, combining multi-step immunological enrichment and single-cell isolation to retrieve intact circulating fetal cells and perform whole-genome sequencing on each cell.
3. Clinical Validation
In internal validation, Unity Confirm achieved 100% concordance with invasive diagnostic outcomes across 16 specimens, accurately identifying common aneuploidies and the 22q11.2 microdeletion without pregnancy-loss risk.
4. Future Availability
Beyond the initial launch, BillionToOne is enrolling up to 1,000 patients in the largest prospective study of a fetal cell-based confirmation assay, targeting real-world concordance with invasive diagnostic testing.