Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 236

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 236
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 disease and cystic fibrosis without requiring a paternal sample or invasive procedures such as amniocentesis. Since UNITY’s launch, 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, in particular Natera and Myriad, that
have been working on creating competing products that also assess fetal risk for recessive conditions non-invasively, such as Natera’s recently launched competitor product, we believe that our smNGS platform and five years of accumulated data,
along with six peer-reviewed publications for UNITY covering more than 100,000 patients over the course of last six years, will allow us to maintain clear clinical and technical superiority as this type of testing becomes the standard of care. In
addition, while product launches by our competitors can create heightened competition in our prenatal market, we also believe that it can lead to increased awareness, acceptance, adoption of this modality of testing (that we innovated and lead the
field with) by both providers and medical guidelines.

In the oncology market, our main competitors for our therapy selection and response monitoring tests include
Caris Life Sciences, Inc., Foundation Medicine, Inc., which was acquired by Roche Holdings, Inc., Guardant Health, Inc., NeoGenomics Laboratories, Inc., and Tempus AI, Inc. As we expand our oncology offerings into applications such as MRD testing,
as well as potentially testing for early detection in the future, we anticipate facing competition from a broader universe of companies, including Exact Sciences, Grail, Haystack, which was acquired by Quest, and Natera.

Our competitors may offer oncology tests for therapy selection that encompass a broader range of genes, thereby positioning their products as more comprehensive. While
we believe that these larger panels result in reduced sensitivity for identifying actionable variants, their expanded gene coverage enables selection of a wider array of therapies—including some that are not yet approved or immediately
actionable. As the number of approved therapies continues to increase, necessitating the addition of new genetic targets and revalidation of our assays, we may incur higher costs and risk losing customers to competitors if updates to our tests are
delayed.

Many of our competitors, either alone or with their collaborators, may have greater financial and/or other resources than we do, including larger and more
established manufacturing capabilities and marketing, sales, and support functions. Other competitors are in the process of developing novel