$BIAFJul 7, 2026, 12:46 PMAI processed
bioAffinity reports Q2 CyPath Lung test volumes up >200% YoY, a new record
AI Summary
BioAffinity said Q2 2026 CyPath® Lung tests sold rose more than 200% year-over-year and ~30% sequentially, driven by higher utilization among existing clients and a 155% increase in physician offices ordering the test; the company has performed nearly 3,000 tests since launch. Management is pushing deeper utilization, market expansion and new indications (oncology monitoring, asthma/COPD diagnostics) and plans a large-scale longitudinal study to add validation data. A published trial in high‐risk patients reported 92% sensitivity, 87% specificity and a 99% negative predictive value, which the company says could help spare patients unnecessary invasive procedures; CyPath® Lung is marketed as an LDT and is not intended as a sole diagnostic.
Positives
- Q2 CyPath Lung test volumes rose >200% YoY and ~30% QoQ (record quarter)
- 155% increase in physician offices ordering vs Q2 2025 and ~3,000 tests performed to date indicates growing adoption
- Published trial shows high sensitivity (92%) and very high NPV (99%), supporting potential to reduce invasive procedures
Negatives
- Company disclosed volume growth but provided no revenue or financial impact in this update
- CyPath Lung is sold as an LDT and is not intended to be used as a sole diagnostic; regulatory risk for LDTs exists
- Evidence so far is limited to a published trial and case studies; larger longitudinal validation is still pending