Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 20

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 20
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 could otherwise be a bottleneck on sensitivity and specificity of an assay. 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 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. We have more recently entered the oncology market, initially focusing on addressing the highest unmet need areas of therapy selection and response monitoring in late-stage cancer patients. We intend to expand our oncology test offerings into testing of earlier stage cancer patients, including through MRD testing and potentially for early cancer detection. We are in the late stages of development of our first assay for MRD detection, and we anticipate launching this assay in 2026. Longer term, we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection; however, we have not yet

| 10 |     | 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

started development in this area. We expect that any products we launch for MRD or early cancer detection will be laboratory developed tests (LDTs), and the products would not be subject to FDA approval requirements. 11 To date, we have launched multiple products across these large addressable markets. We