Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 155

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 155
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 subsequently decoded using proprietary machine learning and bioinformatic algorithms, enabling us to precisely quantify
cfDNA. The precision and multiplexability of QCT-powered assays make them ideal for addressing clinically significant challenges where sensitivity of rare-variant detection or quantification necessary for
longitudinal measurements is essential. The power of QCTs is best exemplified when the clinical problem itself is quantitative, as in the case of fetal risk assessment of recessive conditions during pregnancy and monitoring of response to
therapy in a cancer patient.

QCTs and our other smNGS technologies also serve as the backbone of our technical operations. We leverage this quantitative foundation
to track samples throughout our workflows, to drive continuous operational improvement, and to support robust quality controls. For instance, QCTs detect cross-contamination down to the level of <0.001% and thereby enable the creation of
carefully constructed and automated end-to-end laboratory workflows, including special laboratory infrastructure, that prevent such cross-contamination that could
otherwise be a bottleneck on sensitivity and specificity of an assay.

The financial impact of our technology platform is substantial. We believe the ability to
quantify biomarkers enables us to rationally design and engineer superior diagnostic tests optimized for clinical performance, scalability, and cost of goods sold (COGS). Our smNGS platform therefore drives our differentiated financial performance
both by enabling the development of unique products and by de-risking clinical studies before dedicating significant resources. Our platform is a key differentiator versus our peers in the molecular
diagnostics space and is protected by a robust and growing collection of patents and proprietary know-how.

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Our product portfolio of ultrasensitive tests touches everyone from the beginning of life, with prenatal genetic testing, to the end
of life, with cancer therapy selection and response monitoring.

We launched our initial prenatal product, UNITY, in 2019. Today, we believe it is becoming the new
standard of care, as evidenced by two recent ACOG practice advisory changes that cited our publications in support of the change. With UNITY, we have leap-frogged the resolution of cfDNA testing from one million base-pair chromosomal abnormalities
to single base-pair recessive conditions. In this highly competitive market with increasing commoditization, our differentiated UNITY Fetal Risk Screen remains the only cfDNA test for these conditions.

We have more recently entered the oncology market, initially focusing on addressing the highest unmet need areas of therapy selection and response monitoring in
late-stage cancer patients. We intend to