Expanded UNITY panel aims to improve fetal risk screening across diverse populations

Expanded UNITY panel aims to improve fetal risk screening across diverse populations | Image Credit: © Salomi art - stock.adobe.com.

BillionToOne has recently launched an expanded version of its UNITY Fetal Risk Screen, now capable of assessing fetal risk for up to 14 recessive and X-linked genetic conditions. This development builds on its original 5-gene panel and introduces 9 additional conditions commonly found in Ashkenazi Jewish and pan-ethnic populations. According to the company, the updated test can be administered as early as 9 weeks into pregnancy, using a single maternal blood sample and without requiring a partner sample.^1,2

Kyle Graham, MD, an ob-gyn and medical advisor at BillionToOne, discussed the clinical implications of the expansion. “Traditional carrier screening provides patients with a maximum risk of 25% for recessive conditions that may affect their baby,” he said. “The 14-gene UNITY Fetal Risk Screen from BillionToOne gives much more precise risk. In fact, Unity can tell parents if the fetal risk for recessive conditions is as low as 1 in 5000 to as high as 90% for more informed decision-making.”

Unlike conventional carrier screening that estimates generic reproductive risk, the UNITY panel offers a direct fetal risk estimate. The expanded panel integrates BillionToOne’s Quantitative Counting Template (QCT) technology, which assesses both maternal carrier status and fetal cell-free DNA from a single blood draw. This approach enables more detailed and pregnancy-specific risk analysis, allowing clinicians to deliver individualized counseling and planning based on actual fetal risk.

The elimination of the need for partner testing is another key shift in prenatal care logistics. Graham said, “Eliminating the need for partner samples significantly simplifies the testing workflow by requiring only a single maternal blood draw, removing logistical barriers and delays associated with coordinating partner testing.” He added that this change helps reduce charting time, inbox messages, and patient anxiety, while allowing clinicians to focus on patient concerns during early pregnancy.

The ability to detect potential health issues at 9 weeks' gestation may offer families critical additional time for care coordination. “Earlier detection at 9 weeks provides families [with] security with direct knowledge about their baby,” said Graham. “It allows crucial additional time to connect with specialists, coordinate comprehensive care plans, and access early interventions, including gene therapies and dietary modifications, before conventional testing methods would identify these conditions.”

BillionToOne emphasized that the expanded panel also addresses equity in prenatal care by incorporating conditions relevant to underserved populations. “This is the test that levels the playing field regardless of race, ethnicity, or socioeconomic background,” said Graham. “The expanded offering specifically addresses health disparities by including 9 additional conditions commonly found in Ashkenazi Jewish and pan-ethnic populations, ensuring these communities have access to relevant genetic screening directly about the fetus, which is not available in standard panels.”

The updated UNITY Fetal Risk Screen is available in both the original 5-gene format and the new 14-gene configuration. It aims to support more inclusive, efficient, and actionable prenatal screening across varied clinical settings.

According to BillionToOne, the goal is to help ob/gyns, maternal-fetal medicine specialists, and genetic counselors deliver earlier, clearer, and more equitable care for all patients.

References:

1. BillionToOne. BillionToOne Launches Expanded Panel for UNITY Fetal Risk™ Screen, Setting New Standard in Prenatal Testing. PR Newswire. May 16, 2025. Accessed June 5, 2025. https://www.prnewswire.com/news-releases/billiontoone-launches-expanded-panel-for-unity-fetal-risk-screen-setting-new-standard-in-prenatal-testing-302457359.html#:~:text=Available%20as%20early%20as%20nine,without%20requiring%20a%20partner%20sample.

2. Graham K. Interview with Dr. Kyle Graham on BillionToOne’s expanded UNITY panel. Contemporary OB/GYN. Published online June 2, 2025.