Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 22

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 22
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-contamination down to the level of <0.001% and thereby enable the creation of carefully constructed and automated end-to-endlaboratory workflows, including special laboratory infrastructure, that prevent such cross-contamination that could otherwise be a bottleneck on sensitivity and specificity of an assay. 14 The financial impact of our technology platform is substantial. We believe the ability to quantify biomarkers enables us to rationally design and engineer superior diagnostic tests optimized for clinical performance, scalability, and cost of goods sold (COGS). Our smNGS platform therefore drives our differentiated financial performance both by enabling the development of unique products and by de-riskingclinical studies before dedicating significant resources. Our platform is a key differentiator versus our peers in the molecular diagnostics space and is protected by a robust and growing collection of patents and proprietary know-how. Our solution and suite of products Our product portfolio of ultrasensitive tests touches everyone from the beginning of life, with prenatal genetic testing, to the end of life, with cancer therapy selection and response monitoring. We launched our initial prenatal product, UNITY, in 2019. Today, we believe it is becoming the new standard of care, as evidenced by two recent ACOG practice advisory changes that cited our publications in support of the change. With UNITY, we have leap-frogged the resolution of cfDNA testing from one million base-pair

| 13 |     | Tsao, D. S., Silas, S., Landry, B. P., Itzep, N. P., Nguyen, A. B., Greenberg, S., Kanne, C. K., Sheehan, V. A., & Lo, Y. H. (2019). A novel high-throughput molecular counting method with single basepair resolution 
 enables accurate single-gene NIPT. Scientific Reports, 9, 14382.                                                                                                                                                       |

| 14 |     | See our patent for “Quality Control Templates for Ensuring the Validity of Sequencing-Based Assays” U.S. Patent No. 11,629,381. See section entitled “Intellectual Property” on page 163 for more 
 information.                                                                                                                                                                                      |

6

chromosomal abnormalities to single base-pair recessive conditions. In this highly competitive market with increasing commoditization, our differentiated UNITY Fetal Risk Screen remains the only cfDNA test for these conditions with peer-reviewed clinical publications. We have more recently entered the oncology market, initially focusing on addressing the highest unmet need areas of therapy selection and