Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 201

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 201
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veson, I.W., Gong, B., Lai, K. et al. Evaluating the analytical validity of circulating tumor DNA sequencing assays for precision oncology. Nat Biotechnol 39, 1115-1128 (2021). |

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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 58, 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. Moreover, 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 Northstar Select and Comparators Detected by Comparators Only Comparators 12345 0.5% VAF 0.2% VAF Detected by Northstar Select Only

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Northstar Response In January 2023, we launched Northstar Response, a pan-cancersmNGS-based liquid biopsy test that precisely measured more than 500 genomic loci uniquely methylated in cancer, 59achieving single-molecule level quantification, without the need for an upfront tissue-sample.