bioAffinity Technologies

BIAFPre-clinical

San Antonio, United StatesFounded 2014bioaffinitytech.com

bioAffinity Technologies is dedicated to improving cancer outcomes through its proprietary porphyrin-based platform technology, which enables analysis of the lung microenvironment. The company's lead product, CyPath® Lung, has demonstrated high sensitivity and specificity in clinical studies for detecting early-stage lung cancer and is commercially available as an LDT. bioAffinity is actively expanding its platform to develop targeted diagnostics and therapeutics for other cancers and lung diseases, positioning itself at the intersection of precision diagnostics and cellular-level cancer treatment.

Market Cap

$12.3M

Founded

2014

Focus

Diagnostics

BIAF · Stock Price

USD 2.73246.27 (-98.90%)

Historical price data

AI Company Overview

Technology Platform

Proprietary porphyrin-based platform using Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) that preferentially labels cancer cells, combined with automated flow cytometry and AI-driven analysis to detect malignant changes in the lung microenvironment through non-invasive sputum testing.

Funding History

Total raised: $17M

IPO$10MUndisclosedAug 12, 2022

Series A$5MUndisclosedJun 15, 2017

Seed$2MUndisclosedJun 15, 2015

Opportunities

Significant growth opportunity exists in expanding the porphyrin platform beyond lung cancer to other malignancies and lung diseases like COPD and asthma.

The company can leverage its CLIA-certified laboratory infrastructure to develop additional LDTs while pursuing therapeutic applications of its cancer-targeting porphyrin technology.

Partnerships with larger diagnostic or pharmaceutical companies could accelerate development and commercialization.

Risk Factors

Key risks include limited commercial traction for CyPath® Lung, evolving LDT regulations that could increase compliance costs, intense competition from better-funded diagnostic companies, and the capital-intensive nature of diagnostic commercialization and platform expansion.

The company's small market cap limits financial flexibility for large-scale trials and marketing initiatives.

Competitive Landscape

bioAffinity faces competition from established liquid biopsy companies (Guardant Health, Exact Sciences), traditional diagnostic methods, and imaging-based approaches. Its differentiation lies in the unique porphyrin-based technology, non-invasive sputum testing, focus on early-stage detection, and integration of flow cytometry with AI analysis. Success will depend on demonstrating superior clinical utility and cost-effectiveness compared to existing alternatives.