Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 248

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 248
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 Failure to maintain CAP accreditation could have a material adverse effect on the sales of our tests and the results of our operations.

California laboratory licensing

In addition to federal certification
requirements for laboratories under CLIA, we are required under California law to maintain a California state license for both our Menlo Park and Union City clinical laboratories, and to comply with California state laboratory laws and regulations,
because our laboratories are located in California, and both facilities test specimens originating from California. Similar to the federal CLIA regulations, the California state laboratory laws and regulations establish standards for the operation
of a clinical laboratory and performance of test services, including the education and experience requirements of the laboratory director and personnel (including requirements for documentation of competency), equipment validations, and quality
management practices. All testing personnel must maintain a California state license or be supervised by licensed personnel, and our laboratory director must maintain an additional license issued by the California Department of Public Health (CDPH).

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Clinical laboratories are subject to both routine and complaint-initiated
on-site inspections by the state. If a clinical laboratory is found to be out of compliance with California laboratory standards, the CDPH may suspend, restrict or revoke the California state laboratory
license to operate the clinical laboratory (and exclude persons or entities from owning, operating, or directing a laboratory for two years following license revocation), assess civil money penalties, and/or impose specific corrective action plans,
among other sanctions. Clinical laboratories must also provide notice to CDPH of any changes in the ownership, directorship, name or location of the laboratory. Failure to provide such notification may result in revocation of the state license and
sanctions under the CLIA certificate. Any revocation of a CLIA certificate or exclusion from participation in Medicare or Medicaid programs may also result in suspension of the California state laboratory license.

New York laboratory licensing

In order to test specimens in our laboratories
originating from, and return test results to, New York State, both of our laboratories are required to obtain a New York state laboratory permit and comply with New York state laboratory laws and regulations. We maintain a valid permit in the state
of New York for the prenatal molecular genetic testing services furnished by our Union City laboratory and we are in the application process to obtain a permit in the state of New York for the oncology molecular genetic testing services furnished by
our Menlo Park laboratory.

The New York state laboratory laws, regulations and rules are equal to or more stringent than the CLIA regulations and establish
standards for the operation of a clinical