bioAffinity Technologies Inc (NASDAQ: BIAF) is a clinical-stage diagnostic and biopharmaceutical company focused on early lung cancer detection. The company has generated limited revenue to date and funds operations through equity and debt issuances, having raised gross proceeds of approximately $58.2 million cumulatively through its IPO, warrant exercises, and securities offerings as of the 10-K filed March 16, 2026. It operates in the diagnostic technology segment, competing against diagnostic, pharmaceutical, and biotechnology companies developing alternative lung cancer detection technologies. The company faces intense technological competition from industry peers, universities, and governmental entities. As of FY2025, depreciation and amortization totaled approximately $505,000, and total other expense, net was $4.3 million, driven primarily by warrant liability remeasurement and offering costs. Going concern uncertainty is disclosed in the FY2025 financial statements. Leadership includes Chief Medical Officer Gordon Downie, MD, Ph.D., Chief Science Officer William Bauta, Ph.D., and Chief Operating Officer Xavier Reveles.

Revenue model

bioAffinity Technologies has generated limited revenue to date. Operations are funded through successive equity and debt offerings, including a May 2025 public offering ($3.25 million gross proceeds), an August 2025 Series B Convertible Preferred Stock private placement ($990,000 gross proceeds), and an October 2025 registered direct offering ($1.8 million gross proceeds), as disclosed in the 10-K filed March 16, 2026.

Products and services

The company is developing diagnostic tests and biopharmaceutical products targeting early lung cancer detection. Its pipeline involves diagnostic technology subject to FDA regulatory pathways, including NDA and CLIA laboratory frameworks. Specific commercialized products are not described in the available filing excerpts.

Customers and end markets

Target end markets include third-party payors, healthcare professionals, and clinical investigators in the lung cancer diagnostics space, as referenced in the 10-K filed March 16, 2026. Specific customer counts or revenue concentration data are not disclosed in the available excerpts.

Value-chain role

bioAffinity Technologies occupies an early-stage research and development role in the diagnostic value chain, with clinical laboratory operations managed internally under CLIA standards. It relies on third-party manufacturers and subcontractors subject to FDA cGMP requirements.

Geographic exposure

The company references U.S. federal and state regulatory frameworks as its primary operating environment. EU GDPR and CE marking requirements for in vitro diagnostic devices are noted as applicable regulatory considerations, suggesting potential international commercial ambitions, though no specific geographic revenue breakdown is disclosed in the available excerpts.

Source: SEC 10-K, filed 2026-03-16

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