Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 228

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 228
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On March 31, 2025, the U.S. District Court for the Eastern District of Texas vacated the final rule in its entirety, holding that the FDA’s attempt to
regulate professional laboratory testing services as medical devices exceeds the authority granted to the FDA. The FDA elected not to appeal the U.S. District Court decision within the required 60-day required window. As a result, the future of the
rule, and any enforcement approach by the FDA in this area, is uncertain.

Clinical Laboratory Improvement Amendments of 1988, College of American Pathologists, and state regulations

Clinical Laboratory Improvement Amendments (CLIA)

As a clinical laboratory, we are required to hold certain federal and state licenses, certifications or permits to conduct our business. As to federal certifications,
the Clinical Laboratory Improvement Amendments of 1988 (CLIA) establishes rigorous quality standards for all commercial laboratories that perform testing on human specimens for the purpose of providing information for the diagnosis, prevention, or
treatment of disease or

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the assessment of the health or impairment of human beings. CLIA requires such laboratories to be certified by the federal government and mandates compliance with various operational, personnel,
facility, administration, quality and proficiency testing requirements intended to ensure the accuracy, reliability and timeliness of patient test results. CLIA certification is also a prerequisite to be eligible to bill state and federal health
care programs, as well as many commercial third-party payors, for laboratory testing services.

Our laboratories located in Menlo Park and Union City, California,
are CLIA certified and must comply with all applicable CLIA regulations and standards. If a clinical laboratory is found to be out of compliance with CLIA standards, CMS may impose sanctions; suspend, limit or revoke the laboratory’s CLIA
certificate (and prohibit the owner, operator or laboratory director from owning, operating, or directing a laboratory for two or more years following license revocation); subject the laboratory to a directed plan of correction, on-site monitoring, civil monetary penalties, civil actions for injunctive relief, criminal penalties; or suspension or exclusion from the Medicare and Medicaid programs.

CLIA provides that a state may adopt laboratory licensure requirements and regulations that are more stringent than those under federal law and requires compliance with
such laws and regulations. A number of states have implemented their own more stringent laboratory regulatory requirements. State laws may require the laboratory to obtain state licensure and/or laboratory personnel to meet certain qualifications
and obtain professional licensure, specify certain quality control procedures or facility requirements, or