Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 156

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 156
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 expand our oncology test offerings into testing of earlier stage cancer patients, including through minimal residual disease (MRD) testing and potentially for early cancer detection.

To date, we have launched multiple products across these large addressable markets. We performed more than smNGS-based tests in the last 12
months ended June 30, 2025, with significant room to further grow test volume in both markets.

Prenatal products

Traditional prenatal screening focuses on assessing a fetus’ risk for larger chromosomal changes. However, many common and severe
conditions are the result of much smaller genetic changes, in single base pairs. These recessively inherited conditions, including SCD, alpha thalassemia, beta-thalassemia, CF, and SMA, are collectively more common than aneuploidy conditions like
Down syndrome. Yet these conditions cannot be directly tested with traditional NIPT since each condition requires the precise quantification of fetal cfDNA.

Given
the technical challenges of directly assessing the fetal risk for these conditions, current medical guidelines recommend that every pregnant patient is offered carrier screening, with father screening then required if the mother is found to be a
carrier. However, studies estimate that fewer than half of fathers complete the recommended screening due to barriers related to cost, availability, and willingness. As a result, approximately 58% of pregnancies affected by these recessive
conditions are undetected by traditional screening workflows.

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Our UNITY Fetal Risk Screen directly addressed these challenges and is the first test that uses cfDNA to provide
precise fetal risk assessments for recessive conditions without requiring a paternal sample. In addition, it reports fetal aneuploidy and 22q11.2 microdeletion, enabling complete genetic insights from a single maternal blood draw. We estimate the
prenatal market represents an annual opportunity of over $2.5 billion in the United States.

Oncology products

Non-invasive liquid biopsy tests are a rapidly growing approach to detect and measure tumor
DNA, driven by the increasing focus on molecular-targeted cancer treatments. However, current imaging and conventional liquid biopsy approaches present critical shortcomings, including missed actionable mutations and delays in detecting treatment
response and progression.

In 2023, we entered the oncology market with two complementary products that leverage our smNGS platform to address these unmet needs.
Northstar Select, our ultrasensitive liquid biopsy test, provides insights into appropriate therapies for stage III or IV cancer patients. In a head-to-head study
present