Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 218

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 218
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 a cancer’s development and evolution, certain genes may replicate in number, driving uncontrollable growth. CNVs are increasingly recognized as hallmarks of cancer. While there are therapies that target these CNVs, CNVs are very difficult to detect in plasma due to amplification bias inherent in standard NGS approaches. smNGS-based Northstar Select solves this problem and achieves an LOD that is approximately five to eight times lower than other liquid biopsies.

| 62 |     | Deveson, I.W., Gong, B., Lai, K. et al. (2021). Evaluating the analytical validity of circulating tumor DNA sequencing assays for precision oncology. Nature Biotechnology, 39(9), 1115–1128. |

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Single Nucleotide Variants (SNV) 0.5% 0.4% 0.3% 0.2% 0.1% Other Common 0.25% -0.50% Assays Copy Number Variants (CNV) 3.00 copies 2.75 Other Common Assays 2.50 -2.87 2.50 lower 0.15% level of detection 2.25 NORTHSTAR SELECT 2.00 2.11 NORTHSTAR SELECT lower level of detection baseline Northstar Select detects >50% more actionable mutations than comparator assays In a head-to-headclinical validation study, we compared the performance of Northstar Select against commonly used first-generation ctDNA comprehensive genomic profiling assays. Northstar Select found superior detection rates with 51% more actionable SNVs and Indels, and 109% more CNVs than conventional liquid biopsies. 63Moreover, the study results showed that variants detected at VAF below 0.20% were overwhelmingly detected by Northstar Select only, demonstrating Northstar’s superior sensitivity. In practice, finding more actionable variants can help oncologists more effectively plan treatment for their patients, improving overall patient care. 364 Superior detection rates for SNVs, indels, and CNVs 51% more SNVs/Indels 549 SNVs/Indels 22 109% more CNVs 46 CNVs Comparators NORTHSTAR SELECT Comparators NORTHSTAR SELECT Variants detected at VAF below 0.20% were overwhelmingly detected by Northstar Select(R) only % VAF % Variant Allele Fraction (VAF) 100 10 1 0.1 0.01 0.001 Detected by Both North