BillionToOne Launches Expanded Panel for UNITY Fetal Risk™ Screen, Setting New Standard in Prenatal Testing

The new offering provides precise fetal risk assessment for up to 14 prevalent and actionable recessive and X-linked conditions, in addition to aneuploidies, as early as nine weeks into pregnancy — all from a single maternal blood sample

MENLO PARK, Calif., May 16, 2025 /PRNewswire/ -- BillionToOne, Inc., a molecular diagnostics company with a mission to create the most powerful and accurate tests that are accessible to all, announced today the launch of an expanded offering for providers utilizing the UNITY Fetal Risk™ Screen. This expanded offering screens for the five recessive, severe, and actionable conditions that American College of Obstetricians and Gynecologists (ACOG) guidelines recommend offering screening for in every pregnancy¹ plus nine additional actionable conditions commonly found in Ashkenazi Jewish and pan-ethnic populations.² Available as early as nine weeks into pregnancy, this increases the clinical impact of BillionToOne's first-and-only cell-free DNA testing for such single-gene conditions. It assesses fetal risk for up to 14 prevalent and clinically actionable recessive and X-linked conditions, without requiring a partner sample.

This new addition complements the existing UNITY Fetal Risk™ Screen 5-gene panel, delivering critical insights for OB/GYNs, Maternal Fetal Medicine specialists, Genetic Counselors, other providers, and patients and families alike. Unlike traditional carrier screenings that provide generic reproductive risks of up to 1 in 4, UNITY Fetal Risk Screen delivers a precise fetal risk ranging from as low as 1 in 5000 to as high as 9 in 10, enabling more informed decision-making during pregnancy³. With the introduction of the expanded panel, UNITY Fetal Risk Screen is available for both 5-gene and 14-gene offerings. The 14-gene offering is a combination of 5-gene carrier screening panel, 8-gene carrier screening panel, Fragile X testing, and cell-free DNA test for fetal risk assessment when a pregnant mother is identified as a carrier for one of the conditions. Therefore, it covers a broader range of genetic conditions, many of which are clinically actionable if caught early, enabling families to take early steps toward managing potential health risks for their babies. Specifics about each panel, including conditions screened, can be found here.

"The ability to screen for a more comprehensive range of conditions at just nine weeks gestation represents a paradigm shift in prenatal care," said Dr. Aabeen Hagroo, DO, an obstetrician-gynecologist at Trinity Health IHA Medical Group. "The expanded 14-gene offering allows us to identify potential health challenges months before conventional testing methods. For conditions where early intervention is crucial, this additional time can be transformative – allowing families to connect with specialists, coordinate care plans, and access treatments that could significantly improve their child's health outcomes."

BillionToOne's UNITY Fetal Risk Screen uses patented Quantitative Counting Template™ (QCT™) technology to analyze both maternal carrier status and fetal cell-free fetal DNA (cfDNA) from a single blood sample. QCTs count cfDNA molecules with single base pair precision, accurately assessing fetal risk for recessive conditions when the mother is a carrier, without requiring partner testing.⁴ This technology represents the highest level of resolution, advancing beyond the detection capabilities used for aneuploidies and microdeletions to accurately assess recessive conditions.

"At BillionToOne, we are committed to pushing the boundaries of molecular diagnostics and improving prenatal care," said Oguzhan Atay, Ph.D., Co-founder and CEO of BillionToOne. "By expanding our products to include a 14-gene offering that includes these prevalent and actionable conditions, we're providing healthcare providers and expectant parents with vital information that can significantly impact pregnancy management and long-term health outcomes."

The 14-gene offering provides several key advantages for both healthcare providers and expectant parents:

• Earlier detection of up to 14 genetic conditions at nine weeks gestation
• Precise, pregnancy-specific risk assessment from a single maternal sample
• Timely information for early intervention planning, including access to gene therapies, dietary modifications, and specialized care
• Simplified testing process without the need for partner samples

For more information about UNITY, visit www.unityscreen.com.

About BillionToOne
Headquartered in Menlo Park, California, BillionToOne is a precision diagnostics company on a mission to make molecular diagnostics more powerful, accurate, and accessible for all. The company's single-molecule NGS (smNGS) platform, which includes the patented Quantitative Counting Template (QCT) technology, is the only multiplex methodology that can accurately count DNA molecules at the single-molecule level. For more information, please visit www.billiontoone.com.

Media Contact: [email protected] 

¹ American College of Obstetricians and Gynecologists. (2017). Carrier screening in the age of genomic medicine (Committee Opinion No.690). Obstetrics & Gynecology, 129(3), e35–e40.
² BillionToOne, Inc. Carrier frequencies. Retrieved April 2025, from https://www.unityscreen.com/carrier-frequencies.
³ Hoskovec, J., et al. (2023). Maternal carrier screening with single-gene NIPS provides accurate fetal risk assessments for recessive conditions. Genetics in Medicine, 25(2), 100334.
⁴ Tsao, D. S., et al. (2019). A novel high-throughput molecular counting method with single base-pair resolution enables accurate single-gene NIPT. Scientific Reports, 9, 14382.

SOURCE BillionToOne