BillionToOne Launches Unity Confirm™: A category-defining test that bridges the gap between screening and invasive diagnostics
A breakthrough in prenatal care, Unity Confirm enables non-invasive confirmation for high-risk screening results through the capture of intact circulating fetal cells using
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 publications1 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 fraction2, 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 insights3 non-invasively, from a single blood draw.
"For years, the idea of capturing whole fetal cells non-invasively was largely viewed as an elusive holy grail, something theoretically possible but practically out of reach," said
"A high-risk NIPT result does not give you a diagnosis. It gives you a decision to make under enormous stress, often without enough information," said
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
*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.
Sources
1Hatt, Lotte, et al. "A new marker set that identifies fetal cells in maternal circulation with high specificity." Prenatal Diagnosis 34.11 (2014): 1066-1072.; Stampalija, T., et al. "Single-cell-based non-invasive screening for fetal pathogenic microimbalances using maternal blood: comparison with invasive prenatal diagnosis." Ultrasound in Obstetrics & Gynecology (2026).; Weymaere, Jana, et al. "Enrichment of circulating trophoblasts from maternal blood using filtration-based Metacell® technology." Plos one 17.7 (2022):e0271226.; Jeppesen,
2In 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.
3Unity 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.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of federal securities laws. These forward-looking statements generally are identified by the words "believe," "project," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Forward-looking statements in this press release include, but are not limited to, statements regarding the clinical effectiveness of Unity Confirm. These statements are based on management's current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, some of which are beyond BillionToOne's control. These and additional risks and uncertainties could affect BillionToOne's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. These risks and uncertainties include, but are not limited to, the risk that Unity Confirm is not clinically effective and not adopted by healthcare professionals and those discussed under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" and elsewhere in BillionToOne's most recently filed Annual Report on Form 10-K, and other filings we make with the Securities and Exchange Commission from time to time. The forward-looking statements in this press release are based on information available to BillionToOne as of the date hereof, and BillionToOne disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing BillionToOne's views as of any date subsequent to the date of this press release.
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