Company: BIAF
Filing Date: 2025-05-07
Form Type: 424B4
Source: 0001641172-25-008977
Chunk: 119

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-07
Form: 424B4
Chunk 119
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 In its Opinion and Order, the Court states that, “the text, structure, and history of the FDCA and CLIA make clear that FDA lacks the authority to regulate laboratory-developed test services”. Throughout its opinion, the Court outlines its disagreement with the FDA’s expansion and interpretation of the definition of “device” and the agency’s overall interpretation of its authority to regulate LDTs under the FDCA. ( See 5 U.S.C. § 706(2)).

Specifically, the Court states LDTs are services regulated under CLIA, for which CMS is primarily responsible for issuing implementing regulations. The Court notes that Congress created a separate statutory and regulatory framework for laboratory test services under CLIA. In its opinion, the Court defines an LDT as “a methodology or process by which a laboratory generates biochemical, genetic, molecular, or other forms of clinical information about a patient specimen for use by the treating physician” and that “[e]ach laboratory uses its own unique knowledge of the protocols, performance characteristics, and means of analysis to develop such methodologies and processes”.

By employing this particular definition of LDTs, the Court claims that LDTs are services that laboratory professionals perform rather than a physical product sold by a laboratory that could be subject to FDA jurisdiction as a device. As a result, the Court vacated and set aside the LDT Final Rule in its entirety, holding that the LDT Final Rule exceeds the FDA’s statutory authority and violates the Administrative Procedures Act (APA). Due to the Court’s order, the LDT Final Rule will not go into effect as planned in May 2025. Unless appealed by the government, this ruling essentially halts the FDA’s ability to promulgate further regulations or guidance regulating LDTs.

Clinical Laboratory Improvement Amendments of 1988

Clinical laboratories testing specimens collected in the U.S. for the purpose of disease diagnosis or health assessment are subject to CLIA, unless exempt. CLIA establishes quality standards for all clinical laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. In particular, these regulations mandate that clinical laboratories must be certified by the federal government or an accreditation organization with deemed status from the federal government or must be located in a state that has been granted exemption from CLIA requirements because the state has laws in effect that provide for requirements equal to or more stringent than CLIA requirements. CLIA also requires that laboratories meet quality assurance, quality control and personnel standards, perform proficiency testing, and undergo