Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 168

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 168
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 tumor profile. However, tissue biopsies can be invasive,
challenging to obtain, and can lead to inconclusive results and quality control failures from the extracted DNA. They may also miss mutations due to tumor heterogeneity. In addition to tissue biopsies,
non-invasive liquid biopsy tests are a rapidly growing approach to analyze tumor DNA. Faster and more convenient blood-based tests may allow earlier treatment; however, they also have lower sensitivity due to
very low amounts of circulating tumor DNA (ctDNA) shed by tumors. This challenge has meant traditional liquid biopsies often miss targetable tumor mutations at lower ctDNA fractions.

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Our Northstar Select test addresses these challenges by capturing tumor-specific variants with high sensitivity at low
variant allele frequencies (VAF). In essence, our test enables physicians to detect mutations in cancers that other diagnostic tests might miss. The detection of these mutations can enable better, more targeted therapies that their patients would
otherwise not receive. We have demonstrated the analytical and clinical validity, as well as the clinical utility, of our Northstar Select test through rigorous reviews. In February 2025, these reviews resulted in the decision to grant Medicare
coverage for the Northstar Select test for eligible 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-head concordance 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.

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 though the treatment is working. Scar tissue forming around tumors can be hard to distinguish from active cancer.
Certain areas of the body,