Unity Confirm fetal cell-based test launches for non-invasive confirmation of high-risk prenatal screening results

BillionToOne, Inc. has announced the launch of Unity Confirm, a non-invasive confirmation test that utilizes circulating fetal cells to verify high-risk prenatal screening results. The test is designed to provide diagnostic insights from a maternal blood draw, offering an alternative to invasive procedures such as chorionic villus sampling (CVS) or amniocentesis for patients who receive high-risk findings during initial aneuploidy screening. Beginning May 28, 2026, clinicians using the Unity Aneuploidy Screen will have access to Unity Confirm following a high-risk result.¹

Although non-invasive prenatal testing (NIPT) is currently the standard for aneuploidy screening, high-risk results and can require confirmation through invasive diagnostics, which should be offered to patients, according to the American College of Obstetricians and Gynecologists’ (ACOG) current guidance.²

According to ACOG, “there is a very small chance of pregnancy loss with amniocentesis.” According to the medical society, CVS carries a “slightly higher” chance of miscarriage than amniocentesis.³ Because of these small chances of pregnancy loss, some patients may choose to decline these diagnostic approaches.¹ This is where the circulating fetal cell-based confirmation test aims to fill the gap.

Technology and clinical validation

The scientific challenge of cell-based prenatal genetics has historically been the rarity of fetal cells, which often appear at a frequency of fewer than 1 cell per milliliter of maternal blood. To address this, the test utilizes Fetal Cell Capture technology—a multi-step process involving immunological enrichment and single-cell isolation. This method allows for whole genome sequencing of individual fetal cells, “effectively providing 100% fetal fraction” according to a news release from BillionToOne.

In clinical validation studies conducted by the company, the test demonstrated 100% concordance with known fetal outcomes and invasive results across 16 samples. These samples included cases of common aneuploidies as well as 22q11.2 microdeletion.

“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 Haywood Brown, MD, Chief Medical Officer, Prenatal, BillionToOne. “For too long, the options were limited: forgo confirmation, or undergo an invasive procedure with a small but real risk. What makes Unity Confirm truly different is not just the science; it is that this capability is now clinically accessible. That's not an incremental improvement. That is a fundamentally different standard of care."

Contemporary OB/GYN plans to speak with Haywood Brown, MD, at the 2026 ACOG Annual Clinical & Scientific Meeting. Stay tuned for the video’s publication to learn more about Unity Confirm.

Accessibility and future research

Beginning May 28, 2026, health care professionals using the Unity Aneuploidy Screen will have access to this confirmation test following a high-risk screening result. The technology is intended to modernize the standard of care by providing detailed genetic information without the risks associated with traditional invasive diagnostics.

The company plans to present the technology's clinical data to the ob-gyn community at the ACOG 2026 meeting in Washington, D.C.

Additionally, BillionToOne has initiated a large prospective study. This trial aims to enroll 1000 patients to measure the concordance of the fetal cell-based assay against traditional invasive diagnostic outcomes.

References:

1. BillionToOne Launches Unity Confirm: A category-defining test that bridges the gap between screening and invasive diagnostics. BillionToOne. News release. Published May 1, 2026. Accessed May 2, 2026. https://www.billiontoone.com/news-media/billiontoone-launches-unity-confirmtm-a-category-defining-test-that-bridges-the-gap-between-screening-and-invasive-diagnostics
2. NIPT Summary of Recommendations - Current ACOG Guidance. American College of Obstetricians & Gynecologists. Accessed May 2, 2026. https://www.acog.org/advocacy/policy-priorities/non-invasive-prenatal-testing/current-acog-guidance
3. Prenatal Genetic Diagnostic Tests FAQs. American College of Obstetricians & Gynecologists. Accessed May 2, 2026. https://www.acog.org/womens-health/faqs/prenatal-genetic-diagnostic-tests