bioAffinity Technologies

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bioAffinity Technologies is a public biotech company focused on non-invasive, early-stage cancer diagnostics and targeted treatments. Its core achievement is the commercial launch of CyPath® Lung, a Laboratory Developed Test (LDT) with compelling clinical data (92% sensitivity, 87% specificity for small nodules) that addresses the critical diagnostic gap following indeterminate low-dose CT scans. The company's strategy is to commercialize this first product through its CLIA-certified lab subsidiary while advancing its porphyrin-based platform for broader diagnostic and therapeutic applications in oncology.

A proprietary platform combining porphyrin biochemistry (TCPP) for selective cancer cell labeling, automated flow cytometry for high-throughput sputum analysis, and machine learning algorithms to characterize cell populations indicative of malignancy.

bioAffinity competes in a crowded field but occupies a unique niche with its sputum-based, cellular phenotype approach. It differentiates from genomic tests (Veracyte) and blood-based liquid biopsies (Guardant, Grail) by directly sampling the lung microenvironment, offering high sensitivity for small nodules where other technologies may struggle.