Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 206

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 206
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 otherwise not receive. We have demonstrated the analytical and clinical validity, 51as well as the clinical utility, 52of our Northstar Select test through rigorous reviews. In February beneficiaries with advanced solid tumors who meet the Molecular Diagnostics Services program (MolDX) coverage criteria. The clinical validation data submitted as part of the MolDX evaluation included a head-to-headconcordance study, directly comparing the utility of our test to that of our leading competitors. The results demonstrated the superior sensitivity of Northstar Select by identifying 51% more SNVs and 109% more CNVs, most of which were found below the comparator assays’ 95% limit of detection. All references to clinical validity and clinical utility are distinct from claims of safety and efficacy relating to each of our LDTs.

| 51 |     | Analytical validity refers to how accurately and reliably the molecular diagnostic test measures the specific DNA, RNA, protein, or other molecular target it is designed to detect. Clinical validity refers to the                                  
 accuracy with which a molecular diagnostic test correctly identifies the presence or absence of a specific genetic variant, biomarker, or molecular target associated with a disease or condition in the intended patient population. It measures how 
 well the test performs in distinguishing between patients with a condition or not in clinical practice. Together, these demonstrate whether the molecular test can reliably detect the genetic or molecular changes it’s designed to identify and     
 whether those changes are truly associated with the clinical condition being tested for.                                                                                                                                                              |

| 52 |     | Clinical utility refers to the likelihood that a test will, by prompting an intervention, result in an improved health outcome. The clinical utility of a genetic test is based on the health benefits related to the 
 interventions offered to individuals with positive test results (or improvements in health benefits for avoiding interventions for individuals with negative results).                                                |

145

While the number of cancer treatment options continues to expand, determining whether a specific treatment is working
for an individual patient remains a significant challenge that relies too heavily on subjective assessments. Currently, doctors use medical imaging (e.g., computed tomography (CT) scans, magnetic resonance imaging (MRIs), and positron emission
tomography (PET) scans) as the primary tool to evaluate a patient’s cancer status. However, this approach has important limitations affecting both accuracy and reliability. Tumors often contain diverse cell populations that respond differently
to treatment, making overall assessment difficult. Some patients receiving immunotherapy experience “pseudoprogression,” where imaging temporarily shows growth even