(Incorporated in Delaware)

We specialize in the development of prenatal and oncology diagnostic testing. We were founded in 2016 with a mission to remove the fear of the unknown.

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 (cell-free DNA).

We use a single molecule next-generation sequencing (smNGS) platform) to design prenatal and oncology products that give actionable insights from a simple blood draw. Our products 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.

UNITY, our first prenatal product, was launched in 2019. This product does not require a paternal sample.

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.

In 2023, we launched two pan-cancer liquid biopsy tests – Northstar Select and Northstar Response:

– Our Northstar Select test is used to guide therapy selection. It has been shown to detect over 50% (50 percent) more actionable solid tumor mutations than conventional liquid biopsies.⁵ (See prospectus for footnote reference.)

– 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.

Note: Net loss and revenue are for the 12 months that ended on June 30, 2025.

(Note: BillionToOne filed its S-1 on Oct. 7, 2025, for its IPO without disclosing the terms. Estimated proceeds are $100 million, a placeholder figure.)