Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 26

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 26
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 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 are developing a tissue-free, pan-cancer MRD test, which we expect to be commercially available in 2026. We estimate the annual United States market opportunity for MRD to be over $30 billion. 20Longer term, we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection. While we have not yet started development in this area, the research work that we have done for Northstar Response and MRD is a necessary precursor for early detection development. In particular, we believe that a sensitive tissue-free MRD test, which we have already de-risked by the recent launch of an ultra-sensitive response monitoring assay (Northstar Response v2), which can detect tumor DNA in blood down to a limit of detection (LOD) of 0.01%, can be technically equivalent to an early detection test for cancer. 21We estimate the annual United States market opportunity for early detection to be over $50 billion. 22 Our vision of powering AI-enabledpersonalized medicine for all Healthcare today stands at an inflection point, poised for transformation through the convergence of unprecedented molecular insights and artificial intelligence (AI). Despite significant advances in precision medicine, particularly in oncology where treatments have evolved from being organ-based to increasingly being mutation-based, response rates for many marketed targeted therapies can be as low as single-digit percentages in their indicated patient populations. Similarly, pregnancy care follows one-size-fits-allstandardized protocols despite unique patient biology. Even with broader technological advances, clinicians still cannot reliably predict or prevent major complications like preterm birth, preeclampsia, and gestational diabetes. This sobering reality underscores a fundamental challenge: many current approaches to precision medicine often rely on single biomarkers that fail to capture the full complexity of disease biology and individual patient variation. We believe that these important problems can be addressed in the future with the combination of AI and smNGS technology. We believe AI-enabledpersonalized medicine can revolutionize healthcare delivery across all specialties. Truly personalized medicine requires the (i) characterization of the disease specific to each patient beyond the