Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 67

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 67
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 development programs by a number of potential

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competitors and increasing levels of merger and acquisition and investment activity by both existing and new competitors. Currently, in prenatal, our main competitors offering NIPTs include
Illumina, through its subsidiary Verinata, Laboratory Corporation of America Holdings (Labcorp), Myriad Genetics, Inc. (Myriad), Natera, Inc. (Natera), and Quest Diagnostics Incorporated (Quest). We also compete with companies providing carrier
screening tests such as Fulgent Genetics, Labcorp, Myriad, Natera, and Quest. Each of these companies offers comprehensive carrier screening panels. In oncology, 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, 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. Most if not all of our competitors
sell molecular diagnostic tests and have or may develop tests that compete with ours. In addition, new competitors, including academic medical centers or healthcare providers, may also develop their own tests and may decide to enter our markets.

Some of our competitors and potential competitors may have advantages such as: longer operating histories; larger customer bases; greater brand recognition and
market penetration; substantially greater financial, technological and research and development resources and selling and marketing capabilities; more experience dealing with third-party payors; the ability to secure key inputs from vendors on more
favorable terms; and the ability to adopt more aggressive pricing policies and devote substantially more resources to product development. As a result, our competitors may be able to respond more quickly to changes in customer requirements, devote
greater resources to the development, promotion and sale of their tests than we do or sell their tests at prices designed to win significant levels of market share. We may not be able to compete effectively against these organizations. Furthermore,
certain products offered by our competitors and potential market entrants may have attained FDA approval or Advanced Diagnostic Laboratory Test (ADLT) status. The presence of FDA approval, ADLT status, or both, enables such products to qualify for
higher reimbursement rates, under CLFS, thereby affording competitors