Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 203

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 203
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 carrier for recessive conditions.

| 48 |     | 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.                                                                                                                |

| 49 |     | This estimate includes the most recently reported annual oncology revenue generated by our public company competitors, compared to our estimated $20 billion annual United States market opportunity. For competitors that                          
 do not disaggregate oncology revenue, this estimate is over-inclusive. The competitors included in this estimate are: Bio-Techne, Ltd., Caris, Exact Sciences Corp., Foundation Medicine, Inc., Guardant, Natera and NeoGenomics Laboratories, Inc. |

| 50 |     | 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). 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 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.                                                                                                             |

143

Inherited single gene conditions can be identified through carrier screening of the parents, followed by invasive
diagnostic procedures such as amniocentesis. One of the most significant problems with traditional carrier screening is the requirement for both maternal and paternal blood draws. Obtaining the paternal blood sample is logistically challenging in an
obstetricians-gynecologists (OB-GYN) setting. As reported in studies by independent publications, in at least 58% of cases when the mother is identified as a carrier, the father’s carrier test is not
performed, resulting in the majority of affected pregnancies to be undetected.

Mother's DNA Test Difficult Conversation & Counseling Father's DNA Test Difficult Conversation & Counseling Amniocentesis 58% not completed or unavailable* * Choates et al. Prenat Diagn. 2020;40(3):311-316. 1 positive case per 4 amniocenteses

The significant prevalence of
genetic disorders underscores the critical need for safe and effective prenatal screening methods. By identifying these disorders prenatally, we can significantly improve