Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 171

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 171
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 the fetus requires invasive methods such as amniocentesis or chorionic villus sampling. Prior to such invasive
testing, conventional carrier screening has to be completed and requires a paternal sample. Third party studies estimate that fewer than half of the fathers complete the recommended screening due to barriers related to cost, availability, and
willingness. As a result, at least 58% of pregnancies affected by these conditions are undetected. Our smNGS-based tests offer the level of precision and quantification necessary to overcome these challenges and provide a solution to this problem.

Our UNITY Complete portfolio

Our UNITY prenatal testing portfolio
includes the first sgNIPT that uses cfDNA to achieve precise fetal risk analysis without requiring a paternal sample– a breakthrough that enhances accessibility, ease of use, and adoption across patient populations. In 2020, we added Aneuploidy
and RhD NIPT to create our UNITY Complete offering. In 2022, we added other fetal red blood cell antigens for alloimmunized pregnancies at risk for HDFN without requiring a paternal sample or invasive procedures such as amniocentesis. Our portfolio
delivers unmatched clinical insights through the screening for recessive conditions, aneuploidies, and fetal antigens using a single maternal blood draw. We believe our offering provides the most comprehensive view of fetal health available today.

UNITY Fetal Risk Screen

In 2019, we launched UNITY Fetal Risk Screen as
the first sgNIPT that uses cfDNA to provide fetal risk assessments for recessive conditions. This breakthrough approach addresses a major gap in traditional carrier screening and enhances accessibility, speed, and accuracy for all pregnant patients.
In May 2025, we expanded

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UNITY Fetal Risk Screen’s testing menu to include up to 14 conditions, as shown in the below figure, further enhancing its clinical impact. The first step of the UNITY Fetal Risk Screen involves determining the maternal carrier status. If the mother is identified as a carrier, cfDNA analysis is performed on the same blood sample to assess fetal risk. We believe directly measuring fetal risk through a single maternal blood draw is only possible with the precision and sensitivity provided by our smNGS technology. Within two weeks, the information provided to the clinician and patient includes:

| • |     | Maternal carrier status and any information about the specific variant that may be identified; |

| • |     | A personalized fetal risk score on each condition for which the pregnant mother is a carrier, ranging from