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.

−163,4 %

−242,0 %

−34,2 %

2.60

2.58

— bioAffinity Technologies, Inc.
%
Diagnostic tests20% Noninvasive tests for detecting early-stage lung cancer and other lung diseases, including CyPath® Lung.
Patient service fees65% Clinical pathology services billed for patient testing and related laboratory work.
Histology services10% Tissue processing and histology services provided to pathology customers and labs.
Medical director services5% Physician oversight and medical director support for pathology and laboratory operations.

The company serves patients through physician-ordered pathology and diagnostic testing, with third-party payors such as...

  • Patientsprimary

    Individuals undergoing physician-ordered pathology and CyPath® Lung testing; they are the end customer for most service revenue.

  • Third-party payorsprimary

    Insurance companies and governmental payors that reimburse patient service fees and determine collectible revenue.

  • Hospitalssecondary

    Hospital customers that purchase pathology, histology, and related laboratory services.

  • Independent laboratoriessecondary

    Labs that outsource pathology-related services or require medical director support.

  • Contract research organizationssecondary

    CROs that use the company for specialized pathology and research-related laboratory services.

bioAffinity Technologies is headquartered in the United States and its commercial and laboratory activities are...

  • •United States is the core operating and commercial market
  • •CyPath® Lung has been marketed in Texas
  • •Commercial expansion has included the Mid-Atlantic region
  • •Veterans Administration is a disclosed channel for testing
  • •International regulatory references include Europe and China

The company’s strategy is to expand commercialization of CyPath® Lung while continuing to develop additional diagnostic...

01
Commercialize CyPath® Lungshort-term

The test is the company’s core diagnostic product and a key path to scalable revenue.

02
Develop additional diagnosticsmedium-term

A broader product pipeline can diversify revenue beyond a single lung cancer test.

03
Secure external funding and partnershipsshort-term

Development, trials, and commercialization require capital and strategic support.

The company depends on external financing and has a limited operating history, so execution risk is elevated if...

critical

Financing dependence

Operations and development require external capital if operating cash flow is insufficient.

Scope
Equity, debt, collaborations, grants
Materiality
high
critical

Going-concern and liquidity pressure

The company has disclosed substantial doubt about its ability to continue without additional funding.

Scope
Cash runway and working capital
Materiality
high
high

Regulatory and clinical validation risk

Diagnostic products must clear clinical, laboratory, and regulatory hurdles before broad adoption.

Scope
CyPath® Lung and future diagnostic tests
Materiality
high
high

Competition from larger diagnostics and biotech firms

Competitors may have greater resources, faster approvals, or better commercialization reach.

Scope
Test development and market share
Materiality
high
medium

Reimbursement and credit loss risk

Patient service revenue depends on payor coverage, capped pricing, and collectability.

Scope
Patient fee receivables
Materiality
medium
Patient fee revenue and credit losses
Affects net revenue and accounts receivable
Revenue recognition timing
Affects quarterly comparability
Lease accounting
Affects lease liabilities and depreciation/interest expense
Stock-based compensation
Affects operating expenses and equity dilution
Goodwill and intangible assets
Could create non-cash impairment charges

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: 29/04/2026