Company: BIAF
Filing Date: 2025-05-27
Form Type: 424B5
Source: 0001641172-25-012410
Chunk: 26

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-27
Form: 424B5
Chunk 26
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 for Medicare and Medicaid Services (“CMS”) released a preliminary payment decision for a Current Procedural Terminology (CPT) code for use with CyPath ®Lung that had been issued by the American Medical Association (AMA) in June, 2023. The CPT code became effective October 1, 2023, and is used for private payers and public health insurance programs. The CPT Proprietary Laboratory Analyses (PLA) code assigned to CyPath ®Lung is 0406U with the descriptor “Oncology (lung), flow cytometry, sputum, 5 markers (meso-tetra [4- carboxyphenyl] porphyrin [TCPP], CD206, CD66b, CD3, CD19), algorithm reported as likelihood of lung cancer.” The Company submitted comments during the 30-day comment period in support of the preliminary decision. In November 2023, CMS is expected to finalize the 2024 payment for CPT 0406U, which will be effective January 1, 2024. The recommended CMS payment amount will favorably impact PPLS’ established fee schedule for CyPath ®Lung determining reimbursement by private insurance carriers.

On September 18, 2023, PPLS consummated the acquisition (the “Acquisition”) of a clinical anatomic and clinical pathology laboratory and related services business in San Antonio, Texas (the “Laboratory Assets”) pursuant to the terms of an Asset Purchase Agreement (the “Asset Purchase Agreement”) dated September 18, 2023, that it entered into with Village Oaks Pathology Services, P.A., a Texas professional association (“Village Oaks”) and Dr. Roby P. Joyce, M.D. PPLS is accredited by the College of American Pathologists (“CAP”) and certified under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”). Founded in 2007 by Dr. Joyce, the Medical Director and Laboratory Director of the clinical pathology laboratory prior to and after to the Acquisition, Village Oaks has provided pathology services to physicians practicing in a variety of outpatient settings. Since September 2021, Village Oaks has offered CyPath ®Lung for sale as a laboratory developed test (“LDT”) for the detection of early-stage lung cancer. In addition to CyPath ®Lung, PPLS intends to continue to offer a range of laboratory services including respiratory testing for SARS-CoV-2 and influenza, anatomical pathology,