Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 174

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 174
---
 tissue-free, pan-cancer MRD test, which we expect to be commercially available in 2026. We estimate the annual United States market opportunity for MRD to be over $30 billion. 35Longer term, we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection; however, we have not yet started development in this area. 36We estimate the annual United States market opportunity for early detection to be over $50 billion. 35 Our vision of powering AI-enabledpersonalized medicine for all Healthcare today stands at an inflection point, poised for transformation through the convergence of unprecedented molecular insights and AI. Despite significant advances in precision medicine, particularly in oncology where treatments have evolved from being organ-based to increasingly being mutation-based, response rates for many marketed targeted therapies can be as low as single-digit percentages in their indicated patient populations. Similarly, pregnancy care follows one-size-fits-allstandardized protocols despite unique patient biology. Even with broader technological advances, clinicians still cannot reliably predict or prevent major

| 35 |     | See “Management’s discussion and analysis of financial condition and results of operations—Key factors affecting our results of operations and performance” for more information regarding how these 
 total addressable markets are calculated, including material assumptions.                                                                                                                            |

| 36 |     | While we have not yet started development in this area, the research work that we have done for Response and MRD is a necessary precursor for early detection development. In particular, a sensitive tissue-free MRD test,                               
 which we have already de-risked by the recent launch of an ultra-sensitive response monitoring assay (Northstar Response v2), which can detect tumor DNA in blood down to a limit of detection (LOD) of 0.01%, can be technically equivalent to an early  
 detection test for cancer. Both MRD and early-detection assays are designed to detect minute amounts of cancer DNA in blood (e.g., at levels of 0.01% or even lower). Given the trade off between specificity and sensitivity (LOD), this higher          
 specificity can be, in principle, achieved by changing the calling threshold. The difference with an early detection assay is that it is used in a broader population than MRD, therefore, it needs to have a higher threshold for specificity. As a part 
 of our five-year strategic plan, we have included the necessary R&D funding for development of an early detection test that builds upon our earlier work. We also believe that there is significant potential