Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 207

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 207
---
This powerful combination creates the potential for us to increasingly provide more actionable and personalized clinical reports of treatment strategies while minimizing adverse effects for patients, making our products increasingly more valuable. Industry Background & Market Opportunity The strengths and challenges of precision-based diagnostic solutions Precision diagnostics has emerged as one of the most critical components of healthcare in improving patient outcomes across multiple therapeutic areas. Through the identification of actionable unique biomarkers, diagnostic tests can offer critical information for the diagnosis and treatment of diseases. Historically, directly obtaining a sample from the fetus or the tumor for analysis has been the standard 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.

| 50 |     | 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.”                                                                                                                                                                                   |

143

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