Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 12

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 12
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 biopsy tests are a rapidly growing approach to detect and measure tumor
DNA, driven by the increasing focus on molecular-targeted cancer treatments. However, current imaging and conventional liquid biopsy approaches present critical shortcomings, including missed actionable mutations and delays in detecting treatment
response and progression.

In 2023, we entered the oncology market with two complementary products that leverage our smNGS platform to address these unmet needs.
Northstar Select, our ultrasensitive liquid biopsy test, provides insights into appropriate therapies for stage III or IV cancer patients. In a head-to-head study
presented at American Society of Clinical Oncology (ASCO) annual meeting in 2024, our test demonstrated superior performance by detecting 51% more pathogenic and actionable SNVs and 109% more CNVs than conventional liquid biopsies. Northstar Select
targets the therapy selection cancer diagnostics market, which we estimate is an annual United States market opportunity of over $6 billion.

We simultaneously
launched Northstar Response, the only tissue-free, pan-cancer, smNGS-based liquid biopsy test that precisely measures thousands of genomic loci uniquely methylated in cancer to provide insight into dynamic
changes in therapy response. Validation studies showed Northstar Response’s consistent ability to detect changes in tumor fraction across more than 10 different cancer types, in some cases as much as six months earlier than indicated by imaging
scans. Northstar Response targets the cancer therapy response diagnostics market, which we estimate is an annual United States market opportunity of over $15 billion.

The clinical value of our oncology portfolio is validated by physician adoption. More than 95% of oncologists who order our tests utilize both Northstar Select and
Northstar Response in tandem, highlighting their complementarity in guiding cancer care.

Additional opportunities in oncology

We are actively developing additional diagnostic products to address critical needs across the cancer care continuum. Our current development efforts focus on MRD
detection, leveraging our platform’s exceptional sensitivity to identify trace amounts of tumor DNA following curative-intent surgery in earlier stage cancers. We estimate the annual United States market opportunity for MRD to be over
$30 billion. Longer term, we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection; however, we have not yet started development in this area. We estimate the annual United States
market opportunity for early detection to be over $50 billion.

Our vision of powering AI-enabledpersonalized medicine for all

Healthcare today stands at an inflection point