Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 232

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 232
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.,           
 O’Sullivan, M., Searle, N. E., Hong, L. K., Dogruluk, T., Li, Z., 
 Farmer, T. E., Rosas-Linhard, E., Luong, J., Lin, E., Simon, M.   
 E., Tsao, D. S., Bosch, J. R. T., Palmer, G., Gajra, A., Huynh,   |     | This analytical and clinical validation study evaluated Northstar Select, an 84-gene next generation sequencing panel for blood-based                                                                                                                                                                                                                                                                                                                  
 comprehensive genomic profiling (CGP) of solid-tumor cancers. Northstar Select was validated in head to head comparisons against 6 other commercially available liquid biopsy assays on 182 advanced-stage cancer patients,                                                                                                                                                                                                                            
 exhibiting                                                                                                                                                                                                                                                                                                                                                                                                                                             |

166

| C., & Zhou, W.                                            
 Link*: https://www.sciencedirect.com/science/article/pii/ 
 S2950195425000 384                                        
 DOI: 10.1016/j.jlb.2025.100322                            
 Publication Date: September 2025                          |     | more than 17 different solid tumor types. Results demonstrated Northstar Select’s clear superiority: the                                                                                                                                                
 assay detected 51% more pathogenic single nucleotide variant /Indels and 109% more copy number variants than available comparators, with 45% fewer null reports. Overall, this study found that Northstar Select allows doctors to find more clinically 
 relevant genetic changes, which may help guide treatment decisions - especially for patients with low-shedding tumors.                                                                                                                                  |

Patient Case Studies We believe the following patient case studies are examples of how our patients can benefit from our tests, and highlight one of the important reasons behind physicians’ choice of utilizing our products and platform. We have highlighted patients across our UNITY and Northstar tests. Because these patients cover varied populations and circumstances, we believe the following case studies provide a helpful overview of the results that could be achieved by the broader patient population during the same time periods presented. However, patients experience different results depending on a number of factors, and these case studies are not necessarily representative of the results achieved by other patients. In particular, in a screening setting, such as for our prenatal tests, more than 99% of patients receive negative or low-risk results, which reduce the anxiety and the fear of the unknown for these patients, but do not necessarily improve their healthcare outcomes. UNITY Fetal Risk Screen patient