お知らせ • May 02
BillionToOne, Inc. Launches Unity Confirm
BillionToOne, Inc. announced the launch of Unity Confirm, a circulating fetal cell-based, non-invasive confirmation test, designed to address this need from a simple maternal blood draw. Since its introduction in the early 2010s, non-invasive prenatal testing (NIPT) has become the standard of care for screening for fetal aneuploidies. However, when screening returns a high-risk result, clinical guidelines recommend diagnostic confirmation via chorionic villus sampling (CVS) or amniocentesis. These invasive procedures carry a small but real risk of pregnancy loss, and are increasingly difficult to access. The majority of patients decline, leaving clinicians and families without the information needed to guide next steps, and widening gaps in inequitable care. While cell-based prenatal genetics has been studied since before the advent of cell-free DNA tests, the scientific barrier has long been the rarity and fragility of fetal cells in maternal circulation. Presenting at fewer than one cell per milliliter of blood and nearly indistinguishable from millions of surrounding maternal cells, intact circulating fetal cells have been too difficult to isolate in an accessible way for clinical use. The cell-based approaches were previously studied across multiple independent publications in more than 1,500 patients, consistently demonstrating that when a fetal cell is captured and sequenced, it provides an accurate result that has extremely high concordance with invasive diagnostic testing. However, these methodologies have stayed too academic, expensive, and inaccessible. Unity Confirm addresses this directly. Available for all patients who use UNITY Aneuploidy for their front-line screen, BillionToOne's Fetal Cell Capture technology, a multi-step immunological enrichment and single cell isolation process, isolates intact circulating fetal cells, effectively providing 100% fetal fraction, and performs whole genome sequencing on each individual cell. By analyzing the direct fetal cells rather than fragmentary cfDNA, similar to invasive procedures, Unity Confirm delivers rapid CVS-like insights non-invasively, from a single blood draw. In BillionToOne's own clinical validation, Unity Confirm demonstrated 100% concordance with known fetal outcomes and invasive diagnostic results across 16 of 16 samples, including affected fetuses for common aneuploidies and 22q11.2 microdeletion. The clinical data supporting Unity Confirm will be presented at ACOG 2026 in Washington, D.C., presenting the science behind the technology to the broader OB/GYN community for the first time. Beginning on May 28, providers using Unity Aneuploidy Screen will have access to Unity Confirm following a high-risk result. To further validate performance at scale, BillionToOne is now enrolling in the largest prospective study of a fetal cell-based confirmation assay with invasive diagnostic outcomes, targeting enrollment of 1,000 patients and measuring concordance to invasive diagnostic testing. Unity Confirm is intended for patients who cannot, or choose not to, pursue invasive diagnostic testing following a high-risk Unity Aneuploidy Screen result before 16 weeks of gestation. Available for Trisomy 21 (Down syndrome), Trisomy 18, Trisomy 13, 22q11.2 microdeletion, XXY, XYY, and XXX aneuploidies. Requires Unity Aneuploidy Screen as the frontline screen for the pregnancy. In rare instances, results may rely on a single cell that is co-sequenced with 1-2 maternal cells, which may reduce fetal fraction to 50% or 33%. When this occurs, the report clearly indicates this limitation. Unity Confirm and rapid CVS both analyze fetal-derived trophoblast cells. Unity Confirm isolates individual cells via whole genome sequencing (WGS), which is performed on each cell separately, whereas rapid CVS is often performed via FISH. While rapid CVS may analyze more cells, WGS generates more data per cell. In both rapid CVS and fetal cell capture, mosaicism cannot be excluded. Unity Confirm may have false-positive and false-negative results. Results are not a guaranty. Important medical decisions should not rely on UnityConfirm test results alone. Clinical correlation is necessary. Unity Confirm is a laboratory-developed test performed in a CLIA-certified and CAP-accredited laboratory. It is not an FDA-approved or FDA-cleared diagnostic test. Test performance may vary based on gestational age and other factors.