Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 142

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 142
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 five-gene guideline-focused screening panel. We estimate the 14-geneversion of UNITY Fetal Risk Screen will expand the serviceable addressable market for UNITY by 70%, as some physicians prefer larger panels. 21We plan to continue innovating novel screening and diagnostic products for the prenatal market. We are innovating within our oncology portfolio of products as well. For example, earlier this year, we launched a new version of our Northstar Response test, called Response V2, which provides significant improvements in precision and sensitivity over our original Response product. Importantly, Response V2’s limit of detection at 0.01% tumor allele fraction already matches that of the leading tumor informed MRD assay. This level of sensitivity suggests our potential ability to develop a highly competitive tumor-naïveMRD assay using our smNGS platform. Longer-term we believe we may be able to develop products for even larger segments of the oncology diagnostic market, which we estimate represents an annual market opportunity of over $100 billion in the United States alone.

| 21 |     | This estimate is based on a survey of OB/GYNs and MFMs we conducted in 2023 about their use of carrier screening panels. The survey compared usage of panels covering from 1 condition to more than 100 conditions. Based 
 on the survey responses, we estimate the 14-gene UNITY panel could potentially be used by 70% more service providers compared to the 5-gene panel.                                                                        |

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We believe our smNGS platform will drive our continued and rapid growth in $100B markets. $1B1 Carrier Screening Launched 2019 PRENATAL $1.5B1 Aneuploidy Testing Launched 2020 $6B2 Therapy Selection Launched 2023 ONCOLOGY $15B+3 Therapy Monitoring Launched 2023 $30B+4 Minimal Residual Disease Planned $50B+5 Early Detection Potential

| (1) |     | Estimated $2.5 billion prenatal market assumes two tests per pregnancy (per ACOG guidelines, which also support the use of NIPT for all pregnancies regardless of maternal age or prior risk), over 3.5 million 
 births annually in the United States (per publicly available 2023 CDC data), and an ASP of over $400 per test (consistent with our historical ASP).                                                             |

| (2) |     | Estimated $6 billion therapy selection market assumes 800,000 late-stage cancer patients are