Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 227

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 227
---
6/j.jlb.2025.100322                                    
 Publication Date: September 2025                                  |     | 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 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.                                                                                                                                                                                                                                 |

166

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 case studies: Identifying cystic fibrosis during routine screening

Study 1: A patient with no prior knowledge of being a carrier for cystic fibrosis (CF) underwent routine prenatal testing,
which revealed she was a carrier of CF. The couple, neither with a family history of CF, initially had a general population risk for CF of one in 3,000 to one in 6,000. However, within approximately two weeks of sample collection, results from UNITY
Fetal Risk Screen indicated a nine in 10 chance of the baby being affected with CF through homozygous inheritance of delta F508, leading the patient to opt for amni