Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 231

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 231
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 DOH also must approve each LDT before the test is offered to patients located in New York. Our Union City clinical laboratory has received approval from New
York’s CLEP to offer most of our prenatal tests that are performed in Union City. We are in the application process to obtain approval from New York’s CLEP to offer our Northstar Select test that is performed in our Menlo Park laboratory.

Other state laboratory licensing laws

In addition to New York and
California, certain other states require licensing of out-of-state laboratories under certain circumstances. We have obtained licenses in the states that we believe
require us to do so based on our current operations, and believe we are in compliance with applicable state laboratory licensing laws, including Maryland, Pennsylvania, Rhode Island and the District of Columbia.

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Potential sanctions for violation of state statutes and regulations can include significant monetary fines, the
rejection of license applications, the suspension or loss of various licenses, certificates and authorizations, and in some cases criminal penalties, which could harm our business. CLIA does not preempt state laws that have established laboratory
quality standards that are more stringent than federal law.

State genetic testing and privacy laws

Many states have implemented genetic testing and privacy laws imposing specific patient consent requirements and protecting test results. Under some state laws, we are
prohibited from conducting genetic tests without appropriate documentation of patient (or parental/guardian) consent from the physician ordering the test. For example, Texas enacted legislation limiting use of genetic data applicable to companies
offering direct-to-consumer (without health care provider involvement) genetic testing or collect, use, or otherwise analyze genetic data derived from individuals using
such products or services, but exempt genetic data collected or generated by an entity subject to HIPAA. While we rely on physicians to obtain the required patient consent to perform genetic testing, the regulatory burden may be deemed to be our
responsibility and such consents, or our compliance with applicable laws and regulations, could be challenged. Requirements of these laws and penalties for violations vary widely from state to state.

Federal and state health care laws

As a clinical laboratory, we are
subject to certain federal and state laws and regulations relating to delivery of diagnostic healthcare. To meet the requirements of these laws and regulations, we have developed and operate a compliance program modeled after the general and
specific guidance issued by the Office of Inspector General of the U.S. Department of Health and Human Services (HHS) and grounded in our company ethics and values. Although we believe that our