Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 172

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 172
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. We also believe that there is significant                           
 potential for our smNGS platform to accommodate products in this area. We believe the molecular information provided by our tests can assist in predicting the diagnostic pathway that can confirm the presence and tissue of origin of cancer. |

| 32 |     | See “Risk Factors—Risks related to legal and regulatory matters–Our tests are currently marketed as LDTs, and future changes in FDA enforcement of LDTs could subject our operations to much more 
 significant regulatory requirements.”                                                                                                                                                             |

123

Prenatal products PRENATAL UNITY Fetal Risk Screen: Inherited conditions Aneuploidy Screen: Chromosomal + microdeletion conditions Fetal RhD + Fetal Antigen NIPT: Non-alloimmunized and alloimmunized pregnancies 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 33affected by these recessive conditions are undetected by traditional screening workflows. 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. 34 Oncology products ONCOLOGY Select: Cancer treatment selection NORTHSTAR Response: Cancer treatment response monitoring Minimum Residual Disease (MRD): Cancer detection & surveillance post-surgery In Development Non-invasiveliquid biopsy tests are a rapidly growing approach to detect and measure tumor DNA, driven by the