CyPath Lung passes 1,620 tests through Q3 2026 as bioAffinity reports more than 100% year-on-year sales growth

bioAffinity Technologies reported that CyPath Lung sales increased by more than 100% through Q3 2026 compared with the same period in 2025. The company reports more than 1,620 tests through Q3 2026 versus 775 through Q3 2025, an 89% year-on-year increase in ordering physicians in Q3, and a 48% year-on-year increase in volume among physicians who had already ordered the test through Q3 2025. CyPath Lung uses sputum, flow cytometry and proprietary AI to produce a likely/unlikely malignancy result intended to be interpreted alongside imaging, clinical history, risk factors and guidelines. The source states that it is marketed as an LDT.

AI Evidence Tracker

• Instrument harmonisation: not newly disclosed in this commercial update.
• Fluorescence calibration: not disclosed in this update.
• Metadata completeness: partial for the commercial signal; assay workflow is described but model-development metadata are not.
• External-site validation: commercial use and physician uptake are not equivalent to independent external validation.
• Domain-shift evidence: not reported in this update.
• OOD/failure handling: not reported.

CFCM explainer

Sputum sample → flow-cytometric cellular/porphyrin features → proprietary AI → likely/unlikely malignancy → interpreted with CT imaging + history + risk factors.

Source/credit: CFCM schematic based on bioAffinity's product description, checked 7 October 2026. Alt text: CyPath Lung workflow from sputum through flow cytometry and AI output to combined clinical interpretation.

The sales and ordering-physician figures are company-reported and do not independently demonstrate clinical effectiveness. The release cites earlier clinical-trial performance of 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value in a defined high-risk cohort with small nodules; those are not new Q3 2026 validation data and should not be generalized to all clinical populations. LDT commercial availability must not be described as FDA clearance or approval.

This is a real-world adoption signal for flow cytometry plus AI outside haematological malignancies. It also illustrates why CFCM should track commercial status and regulatory status separately: a test can be clinically ordered as an LDT while still lacking device-level FDA clearance or approval.