Company Description

BillionToOne is transforming healthcare by redefining molecular diagnostics. Our revolutionary single molecule NGS (smNGS) platform achieves what was once thought impossible – detecting and precisely quantifying genetic targets with single-molecule sensitivity. At the heart of this technological breakthrough lies our patented QCTs, enabling measurements at the physical limit of detection – the single DNA molecule. This leap forward addresses a fundamental limitation in healthcare – the inability to detect sparse but clinically crucial disease signals in cfDNA. Our superior technology platform(1) has enabled us to build category-defining prenatal and oncology products. Our products reveal actionable insights from a simple blood draw that are fundamentally changing how diseases are diagnosed and treated, leading to a paradigm shift in personalized medicine. We believe our novel smNGS platform technologies combined with our AI-enhanced integrated workflow, allows us to push the technology frontier forward and deliver on the full promise of non-invasive liquid biopsy, which we estimate has an annual market opportunity of over $100 billion in the United States alone(2). Founded with the mission to remove the fear of the unknown through powerful and accessible smNGS-based diagnostics, we have swiftly transitioned from a research and development (R&D) focused company to a proven commercial organization. In 2019, we launched our first prenatal product, UNITY. UNITY is the first non-invasive prenatal test (NIPT) that uses cfDNA to provide fetal risk assessment for recessive conditions such as sickle cell disease (SCD) and cystic fibrosis (CF) without requiring a paternal sample or invasive procedures such as amniocentesis. Since then, we have established ourselves as a leader in the prenatal testing market and expanded our UNITY offering to cover comprehensive prenatal genetic needs from a single maternal blood draw. While we know of competitors working to develop and launch competing NIPTs for recessive conditions, we believe the differentiation of our smNGS technology and five years of accumulated data and publications will allow us to maintain our competitive advantage as this type of testing becomes the standard of care and significantly improves patient outcomes(3). In the oncology setting, ultrasensitive tests with real-time insights are required to effectively detect, diagnose, and treat patients with a diverse range of mutations and solid tumor types across the cancer care continuum. In 2023, we successfully leveraged our smNGS platform to launch two complementary pan-cancer liquid biopsy tests – Northstar Select and Northstar Response. Our Northstar Select test is used to guide therapy selection and has been shown to detect over 50% more actionable solid tumor mutations than conventional liquid biopsies(4). Based on our knowledge of all widely available tests, Northstar Response is the only methylation-based assay that quantifies the amount of cancer (tumor burden) at the single molecule level without requiring a tissue biopsy, enabling real-time monitoring of patient response to therapy with unprecedented precision. Our Northstar tests give physicians extraordinary visibility into cancer profile and treatment response, enabling more informed and earlier treatment decisions that can fundamentally alter patient outcomes. Our business momentum is evidenced by our rapidly scaling commercial success and improving operational efficiency. Of approximately one million smNGS-based tests that we have processed since our initial launch, over 50% of them, or approximately 508,000 tests, were processed within the last 12 months ended June 30, 2025. For the year ended December 31, 2024, we generated revenue of $152.6 million, representing 113% year-over-year growth, with a gross margin of 53% and net loss of $41.6 million. We have incurred losses since inception, including a net loss of $41.6 million and $4.2 million for the year ended December 31, 2024 and six months ended June 30, 2025, respectively, and we had an accumulated deficit of $286.4 million as of June 30, 2025. Our loss from operations for the six months ended June 30, 2024 and 2025 was $22.8 million and $3.9 million, respectively. Our business model has demonstrated improving operational leverage, which has enabled us to reach, on a non-GAAP income from operations basis, positive operating income after adjusting for stock-based compensation expense for the six months ended June 30, 2025. During this period, we generated revenue of $125.5 million, representing 82% year-over-year revenue growth as compared to the six months ended June 30, 2024, with a gross margin of 65%. This translated to a non-GAAP net operating income of $1.2 million for the six months ended June 30, 2025 compared to a non-GAAP net operating loss of $18.9 million for the six months ended June 30, 2024, which represented an improvement of approximately $20.1 million. Backed by our commitment to continued innovation and high-quality execution, we aim to lead the next wave of advancements in precision diagnostics, delivering profound benefits to patients, providers, and the broader healthcare system. (1) Our smNGS platform overcomes the technical noise that restrains the traditional NGS testing methods used by other diagnostic companies. (2) Half of this addressable market includes early detection, an area in which we have not yet begun specific product development or commercial sales, but we believe will be strongly enabled by our existing technology platform. (3) This is based on (i) our six months ended June 30, 2025 prenatal testing revenue as compared to the publicly disclosed prenatal testing revenue of Myriad Genetics, one of the largest laboratories for prenatal diagnostic testing, and (ii) recent ACOG practice advisory changes for RhD and fetal antigen NIPT have specifically cited our publications, resulting in changes to the standard of care. (4) Bower, X., Wignall, J., Varga, M. G., Zhu, J., O’Sullivan, M., Searle, N. E., Hong, L. K., Dogruluk, T., Li, Z., Farmer, T. E., Rosas-Linhard, E., Luong, J., Lin, E., Simon, M. E., Tsao, D. S., Bosch, J. R. T., Palmer, G., Gajra, A., Huynh, C., & Zhou, W. (2025). Validation of a liquid biopsy assay with increased sensitivity for clinical comprehensive genomic profiling. The Journal of Liquid Biopsy, 100322. --- We commenced operations in 2016 as a Delaware corporation. Our principal executive offices are located at 1035 O’Brien Drive, Menlo Park, CA 94025. Our telephone number is (650) 460-2551. Our website address is www.billiontoone.com.