bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. is a U.S.-based life sciences company that develops noninvasive diagnostic tests for early-stage lung cancer and other lung diseases. Through its clinical pathology operations, it also provides anatomic and clinical pathology services, including patient testing, histology services, and medical director services.
Fiscal year 2025 · change from previous year
Development 2022–2025
Business
Share of revenueNoninvasive tests for detecting early-stage lung cancer and other lung diseases, including CyPath® Lung.
Clinical pathology services billed for patient testing and related laboratory work.
Tissue processing and histology services provided to pathology customers and labs.
Physician oversight and medical director support for pathology and laboratory operations.
Products
Reported · share of revenue- Health Care Patient Service80.7 %
- Histology Service Fees18.1 %
- Medical Director Fees1.1 %
Source: 10-K FY2025, revenue the company reports per product line (SEC XBRL). Shares are of the lines shown and add up to 100 %.
Customers
The company serves patients through physician-ordered pathology and diagnostic testing, with third-party payors such as insurance companies and governmental payors typically responsible for most of the fee. It also sells services to contract research organizations, hospitals, and independent laboratories that need pathology, histology, or medical director support.
Individuals undergoing physician-ordered pathology and CyPath® Lung testing; they are the end customer for most service revenue.
Insurance companies and governmental payors that reimburse patient service fees and determine collectible revenue.
Hospital customers that purchase pathology, histology, and related laboratory services.
Labs that outsource pathology-related services or require medical director support.
CROs that use the company for specialized pathology and research-related laboratory services.
Strategy
The company’s strategy is to expand commercialization of CyPath® Lung while continuing to develop additional diagnostic tests and related products. It also seeks financing and collaborative or licensing arrangements to support clinical development, regulatory progress, and broader market access.
The test is the company’s core diagnostic product and a key path to scalable revenue.
A broader product pipeline can diversify revenue beyond a single lung cancer test.
Development, trials, and commercialization require capital and strategic support.
Geography
bioAffinity Technologies is headquartered in the United States and its commercial and laboratory activities are centered there. The company has disclosed commercialization of CyPath® Lung in Texas, with expansion into the Mid-Atlantic region and the Veterans Administration, while development and regulatory ambitions also reference broader U.S. and international markets.
Risks
The company depends on external financing and has a limited operating history, so execution risk is elevated if commercialization or capital raising slows. It also faces intense competition in diagnostics and biotechnology, plus regulatory and reimbursement risk because test adoption depends on validation, payer coverage, and clinical acceptance.
- Financing dependenceImpact: CriticalLikelihood: High
Operations and development require external capital if operating cash flow is insufficient.
Exposure - Going-concern and liquidity pressureImpact: CriticalLikelihood: High
The company has disclosed substantial doubt about its ability to continue without additional funding.
Exposure: Cash runway and working capital
- Regulatory and clinical validation riskImpact: HighLikelihood: High
Diagnostic products must clear clinical, laboratory, and regulatory hurdles before broad adoption.
Exposure: CyPath® Lung and future diagnostic tests
- Competition from larger diagnostics and biotech firmsImpact: HighLikelihood: High
Competitors may have greater resources, faster approvals, or better commercialization reach.
Exposure: Test development and market share
- Reimbursement and credit loss riskImpact: MediumLikelihood: High
Patient service revenue depends on payor coverage, capped pricing, and collectability.
Exposure: Patient fee receivables
Accounting
Judgemental itemsGross charges are often not collected due to insurer agreements, government caps, and uncollectible balances.
Impact: Affects net revenue and accounts receivable
Testing revenue is recognized when results are reported or services are completed, which can shift quarter-to-quarter.
Impact: Affects quarterly comparability
Finance leased equipment is recorded using incremental borrowing rate assumptions.
Impact: Affects lease liabilities and depreciation/interest expense
Option valuation uses Black-Scholes assumptions that require judgment.
Impact: Affects operating expenses and equity dilution
Acquired pathology and diagnostic assets may require impairment testing if performance weakens.
Impact: Could create non-cash impairment charges
Similar listed companies
Publicly listed companies with a comparable business focus.
PharmaCyte Biotech, Inc.
PMCB · Biological Products, (No Diagnostic Substances)
Biodesix, Inc
BDSX · Services-Medical Laboratories
Biodesix is a U.S.-based diagnostic solutions company focused on lung disease testing and diagnostic development services.
Passage BIO, Inc.
PASG · Biological Products, (No Diagnostic Substances)
Bio-Path Holdings, Inc.
BPTH · Pharmaceutical Preparations
Biotricity Inc.
BTCY · Surgical & Medical Instruments & Apparatus
Intensity Therapeutics, Inc
INTS · Biological Products, (No Diagnostic Substances)
Last updated: 24/09/2026