Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 199

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 199
---
 for compliance with CAP standards every two years. 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).

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

158

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