Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 165

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 165
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 cycle of productivity enhancement and financial performance improvement. By progressively automating routine tasks, we expect to increasingly redirect our
exceptional talent toward high-value, creative activities that drive innovation and competitive differentiation. We believe this will further strengthen our differentiated financial profile by continuously improving the ratio of revenue to operating
expense.

Personalized medicine

We believe that our smNGS platform is
building a uniquely valuable genetics dataset due to its ability to detect single molecules at scale. We have processed over one million tests to date and our dataset continues to grow rapidly. AI can reduce medical chart extraction costs by over
90%, enabling the synthesis of smNGS molecular data and AI-extracted longitudinal clinical data for each patient. This powerful combination creates the potential for us to increasingly provide more actionable
and personalized clinical reports of treatment strategies while minimizing adverse effects for patients, making our products increasingly more valuable.

The strengths and challenges of precision-based diagnostic solutions

Precision diagnostics has emerged as one of the most critical components of healthcare in improving patient outcomes across multiple therapeutic areas. Through the
identification of actionable unique biomarkers, diagnostic tests can offer critical information for the diagnosis and treatment of diseases. Historically, directly obtaining a sample from the fetus or the tumor for analysis has been the standard of
care for prenatal and oncology diagnostics, but such procedures are highly invasive and can lead to inconclusive results. More

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recently, many areas of care, including prenatal and oncology, have been transformed by cfDNA diagnostics. Both genetic and epigenetic properties of cfDNA reflect the originating tissue and can
be used to diagnose and monitor disease. However, while powerful, the extremely limited availability of cfDNA in blood poses significant challenges to traditional diagnostics. The fraction of cfDNA that is of fetal or tumor origin can be as low as
0.01% to 1.0% of the total cfDNA, and often there is only a single molecule that corresponds to the particular mutation of interest within a tube of blood. To address this challenge, the DNA sample must be amplified during laboratory processing by a
factor of millions, which adds significant errors and biases that are then difficult to differentiate from the actual targeted mutations. It also makes quantification extremely challenging, as the original signal can be orders of magnitude smaller
than these errors and biases.

Our market entry strategy and journey

Prior to our entry, the non-invasive prenatal testing market (NIPT) almost exclusively focused on chromosomal abnormalities
called aneuploidies. Other conditions such as cystic fib