BillionToOne Announces Clinical Outcomes Data for UNITY Fetal Risk™ Screen, Demonstrating Exceptional Accuracy in General Pregnancy Population

The study concludes that an effective single-gene NIPT workflow, like UNITY Fetal Risk Screen, can considerably improve outcomes and bolster equity in prenatal care

MENLO PARK, Calif., Oct. 30, 2023 /PRNewswire/ — BillionToOne, a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, announced today that a peer-reviewed research study of the UNITY Fetal Risk Screen has been published in Prenatal Diagnosis. The study demonstrates that the test accurately provides direct fetal insights into prevalent autosomal recessive conditions such as Cystic Fibrosis, Spinal Muscular Atrophy, and Alpha and Beta Hemoglobinopathies (including Sickle Cell Disease). “Given this high accuracy and an NPV of 99.8%, this workflow should be considered as an option for most of the general pregnant population.” the study’s authors concluded.

“The data not only corroborates previous results but also expands upon them by including a wider population of the general pregnant population,” said Oguzhan Atay, PhD, and CEO of BillionToOne. “This study provides strong evidence that the UNITY Fetal Risk Screen is primed to be the new standard in prenatal care.”

In the research, the performance of the UNITY Fetal Risk Screen was evaluated, and demonstrated a sensitivity of 96% in identifying an affected fetus as high risk. The study included patients from 811 clinical practices across 45 states in the U.S., resulting in a study cohort of more than 42,000 patients, representing a general obstetric population. Of these, approximately 18% were identified as carriers. A total of 528 clinical newborn outcomes for positive carrier pregnancies were collected, with at least 75 outcomes per condition.

UNITY Fetal Risk Screen can accurately assess fetal risk for common autosomal recessive conditions without requiring a blood sample from the male partner – the only commercially available test of its kind in the U.S. The risk determined by the UNITY Fetal Risk Screen accurately mirrors the actual risk to the fetus. All fetuses identified at the highest risk level (9 in 10) in the study were confirmed to have an affected child via newborn outcomes; a risk level of 9 in 10 is unattainable with traditional carrier screening tests. Of equal significance, the test’s negative predictive value (NPV) was 99.8%, which implies that a low risk result can be highly reliable.

About UNITY Fetal Risk™ Screen:
UNITY Fetal Risk Screen, developed by BillionToOne, Inc., is a unique prenatal test that includes a carrier screen and fetal risk assessment for recessive conditions. UNITY Fetal Risk Screen provides informative genetic information about the fetus at 10 or more weeks gestation, is non-invasive, and does not require a partner sample at any point in the process to provide a fetal risk. It is the only commercially available NIPT in the United States that assesses fetal risk for recessive conditions.

About BillionToOne:
Headquartered in Menlo Park, California, BillionToOne is a precision diagnostics company on a mission to make molecular diagnostics more accurate, efficient, and accessible for everyone. The company’s patented QCT™ molecular counter platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level.

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