Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 150

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 150
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 same assumptions outlined in (2) above), testing occurs six times per year 
 (consistent with suggested industry intervals for tests with a similar purpose, such as CT scans), an 18-24 month average survival for late-stage cancer patients (based on our analysis of publicly available    
 2025 data from the American Cancer Society), and an ASP of $1,600 per test consistent with the CMS price of our test of $1,644.                                                                                   |

| (4) |     | Estimated over $30 billion minimal residual disease market assumes 18.6 million cancer survivors (based on publicly available 2025 data from the American Cancer Society), two to three tests per patient per     
 year (which we believe is a reasonable assumption for monitoring of this type), and an ASP of $1,000 per test based on the publicly disclosed ASP of competitor MRDs. We are developing a tissue-free, pan-cancer 
 MRD test, which we expect to be commercially available in 2026.                                                                                                                                                   |

| (5) |     | Estimated over $50 billion early detection market assumes eligible patients would include anyone over approximately 40 years of age, which is estimated at 157 million people in the United States (based on our                                                                                                                                                                                                                                                               
 analysis of the most recent U.S. census data), one-third of eligible patients would use an annual test (analogizing publicly reported industry usage of other tests that are recommended on an annual basis as                                                                                                                                                                                                                                                                 
 part of a regular physical exam, such as mammograms and prostate cancer tests), and an ASP of $1,000 per test based on publicly disclosed CMS prices of competing early detection assays ranging from $600 to $1,500. Longer term, we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection. While we have not yet started development in this area, the research work for MRD and our Select and Response tests is 
 a necessary precursor to early detection development. 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. Given the capabilities of our existing tests and stated focus of our development efforts, we believe it is reasonable to include early detection in our                                                                                                                                                                                                                        
 calculation of total addressable market opportunity.                                                                                                                                                                                                                                                                                                                                                                                                                           |

Key components of results of operations Revenue The majority of our revenue is derived from sales of