Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 201

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 201
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 of care for prenatal and oncology diagnostics, but such procedures are highly invasive and can lead to inconclusive results. More recently, many areas of care, including prenatal and oncology, have been transformed by cfDNA diagnostics. Both genetic and epigenetic properties of cfDNA reflect the originating tissue and can be used to diagnose and monitor disease. However, while powerful, the extremely limited availability of cfDNA in blood poses significant challenges to traditional diagnostics. The fraction of cfDNA that is of fetal or tumor origin can be as low as 0.01% to 1.0% of the total cfDNA, and often there is only a single molecule that corresponds to the particular mutation of interest within a tube of blood. To address this challenge, the DNA sample must be amplified during laboratory processing by a factor of millions, which adds significant errors and biases that are then difficult to differentiate from the actual targeted mutations. It also makes quantification extremely challenging, as the original signal can be orders of magnitude smaller than these errors and biases.

| 47 |     | Carrell, D. S., Halgrim, S., Tran, D., Buist, D. S. M., Chubak, J., Chapman, W. W., & Savova, G. (2014). Using natural language processing to improve efficiency of manual chart abstraction in research: The case of                     
 breast cancer recurrence. American Journal of Epidemiology, 179(6), 749–758 “[Natural language processing] could reduce by 90% the number of [electronic health records] charts abstracted to identify confirmed breast cancer recurrence 
 cases at a rate comparable to traditional abstraction.”                                                                                                                                                                                   |

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Our market entry strategy and journey Prior to our entry, the non-invasiveprenatal testing market (NIPT) almost exclusively focused on chromosomal abnormalities called aneuploidies. Other conditions such as cystic fibrosis or sickle-cell disease could only be detected by invasive methods such as amniocentesis following carrier testing of the parents. By first focusing our smNGS platform on directly assessing fetal risk for these conditions, we expanded the indication of NIPT from more than one million base pair aneuploidies to single base pair conditions. Currently, we are the second largest prenatal genetics laboratory in the United States by revenue, achieving a 83% revenue growth rate to $209 million in the 12-monthperiod ended June 30, 2025 from the preceding 12-monthperiod. We estimate the market opportunity