Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 154

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 154
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introduces technical noise that makes it harder for traditional sequencing technologies to accurately quantify the absolute and relative abundance of cfDNA sequences in the biological specimen, resulting in lower sensitivity and specificity.

We have developed a transformative technology platform that redefines the possibilities of cfDNA analysis. In the past, the
significant advancements from polymerase chain reaction (PCR) to Sanger Sequencing to NGS expanded molecular diagnostics from being limited to infectious disease testing and human genome mapping to now becoming standard of care for genetic
screening. Today, we are experiencing another step change as we believe our smNGS platform enables the absolute quantification of cfDNA and we believe overcomes the

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technical noise that restrains the traditional NGS testing methods used by other diagnostic companies. This breakthrough capability enables our
non-invasive diagnostic tests to achieve performance characteristics previously only possible with invasive tissue biopsies from the affected organ.

The cornerstone of our platform is its ability to resolve and quantify individual DNA molecules with absolute precision. This single-molecule resolution provides
extraordinary visibility into the biological signals present in a sample, even when the target DNA represents just one molecule among billions. Beyond mere detection, our technology enables absolute quantification of cfDNA, eliminating the reliance
on relative measurements that has constrained previous approaches. This quantitative foundation allows us to transform every aspect of our operations in a measurable way, from research and development to clinical testing and quality control. While
traditional diagnostic approaches have often relied on trial-and-error experiments to screen for incremental improvements, our smNGS platform does not. The quantitative
nature of the data that our smNGS platform generates is critical to our success in creating ultrasensitive, differentiated molecular diagnostics.

Perhaps most significantly, we believe, our smNGS technology transcends the precision-versus-scale tradeoff that has limited legacy diagnostic methods. Conventional
genetic analysis techniques, such as NGS and digital droplet PCR (ddPCR), typically sacrifice either sensitivity or multiplexing, i.e., ability to interrogate many genomic loci at the same time, forcing compromises in clinical utility. We believe
our platform eliminates this constraint, delivering both high sensitivity and broad genomic coverage simultaneously. This unique capability allows us to provide physicians and patients with more actionable information from cfDNA that was previously
possible only with more invasive diagnostics.

Our smNGS platform is powered by several patented technologies, most notably
the use of synthetic DNA fragments, called QCTs. QCTs encode the molecular information in sequencing data which are