Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 175

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 175
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 and innovation beyond our tests

UNITY Complete is more than just a test, it is a fully integrated, end-to-end experience
that delivers a seamless workflow for both patients and providers. Over the years, we have developed various software tools to support the entire testing workflow for providers and patients, which has fueled the rapid growth of the UNITY Complete
portfolio. We continuously refine our workflow to address the evolving needs of obstetric providers, in an effort to maximize efficiency, accessibility, and ease of adoption for both patients and providers. By combining unique clinical testing with
workflow enhancements, we believe UNITY Complete has established a highly scalable infrastructure that streamlines every step of the journey, further solidifying that UNITY Complete is becoming the new standard in prenatal care.

Oncology products

Precision oncology continues to be a focus in the
global fight to cure cancer. However, despite significant advancements and growth in the field, cancer continues to rank as the second leading cause of death worldwide, with persistently high mortality rates. Liquid biopsies, or blood-based tests
that interrogate ctDNA, cfDNA released from a tumor cell, for therapy selection or disease monitoring have recently become available for clinical practice as non-invasive, rapid and readily available
alternatives to traditional tissue-based biopsies. Despite the increase in uptake, current liquid biopsies developed using standard NGS methods present shortcomings, including undetected actionable mutations and delays in detection of response and
progression. In a head-to-head study presented at ASCO in 2024, we have shown that more than one-third of actionable mutations
are undetected by other liquid biopsies due to lower sensitivities at lower variant allele fractions. Moreover, current products are also limited in their ability to quickly, precisely, and sensitively quantify trends in tumor progression over the
course of treatment.

Our Northstar portfolio

Our Northstar portfolio
for oncology consists of smNGS-based pan-cancer liquid biopsy tests that provide comprehensive therapy selection (Northstar Select) and therapy monitoring (Northstar Response) for late-stage, solid tumor
cancer patients. Using a blood-only approach with a focus on sensitivity and precision, we are committed to pushing the limits of cfDNA testing to ensure patients are getting the most advanced profiling and monitoring tools available, while
maintaining the convenience of a single blood draw.

Northstar Select

In January 2023, we launched Northstar Select, which is an ultrasensitive liquid biopsy test using smNGS. Northstar Select can