Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 215

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 215
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 validity evidence for our MolDX submissions for Medicare coverage.

| • |     | Utilize our smNGS platform and R&D capabilities to efficiently expand and improve our portfolio of category-defining                                                                                                                                
 molecular diagnostic tests. Our foundational smNGS platform fundamentally reduces the biological and clinical risks in our product development process. Because it achieves single molecule level sensitivity and precision at the physical LOD, we 
 can accurately predict clinical performance in advance when designing new smNGS assays. This is complemented by our lean and innovative R&D structure which further enables efficient and high-impact product development. As a result, we are able 
 to rapidly convert R&D investment into differentiated products. In the prenatal market, we started with one UNITY Fetal Risk Screen and then developed multiple tests and add-ons, including UNITY Aneuploidy                                       
 Screen and UNITY Fetal Antigen NIPT. In oncology, we are extending our portfolio beyond our commercial products focused on therapy selection and response monitoring. We are also developing a tissue-free,                                         
 pan-cancer MRD test, which we expect to be commercially available in 2026. Longer-term we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection, among                                   
 other applications.                                                                                                                                                                                                                                 |

| • |     | Leverage our growing clinical dataset with AI to improve the utility of diagnostics and enable personalized                                                                                                                                            
 medicine. Our advanced diagnostics platform generates rich biomarker data as we test patients that can be integrated with multimodal patient clinical information such as medical records. By leveraging AI algorithms to analyze these large          
 datasets, and combining them with our unique Northstar Response results, we believe we will be able to identify distinct patient subgroups with unique biomarker profiles and predict therapeutic response patterns with unprecedented precision. This 
 capability will enable us to provide clinicians with personalized treatment recommendations tailored to each patient’s unique biology. We believe this approach will significantly improve therapeutic outcomes by maximizing efficacy while           
 minimizing adverse effects.                                                                                                                                                                                                                            |

As we continue to expand our clinical data repositories and refine our AI models, we expect to further enhance our competitive advantage and accelerate the transition of precision medicine from aspiration to clinical reality across our diagnostic portfolio. 162

Competition

Healthcare delivery
continues to focus on becoming more patient-centered with personalized solutions. This evolution is leading to more companies and product offerings in the molecular diagnostics market. As a result, each of our products faces competition from a
number of established and emerging companies.

In the prenatal market, our main competitors offering NI