Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 150

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 150
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 operations, which may adversely affect our business. 113

### Business
Overview

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 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.

Founded with the mission to remove the fear of the unknown through powerful and accessible smNGS-based diagnostics, we
have swiftly transitioned from an 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 and cystic fibrosis 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.

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