8-K: bioAffinity Reports Soaring CyPath Lung Test Volume

bioAffinity Technologies announced significant month-over-month growth in CyPath Lung test volume, more than doubling since early 2025.

Summary

• CyPath Lung test volume has increased steadily each month and more than doubled since the start of 2025.
• October 2025 test volume was 111% higher than the 2025 year-to-date monthly average.
• Third-quarter sales volume increased 95% over the prior quarter.
• Medical practices with multiple CyPath Lung orders increased 106% in the third quarter compared to the prior quarter, and 67% in October compared to the 2025 year-to-date monthly average.
• CyPath Lung utilizes proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum indicative of malignancy.
• Clinical study results for CyPath Lung demonstrated 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small lung nodules (less than 20 millimeters).

Sentiment

Score: 8

Explanation: The filing reports strong, accelerating growth in test volume and physician adoption for a key diagnostic product, indicating positive operational momentum and market acceptance.

Positives

• Significant month-over-month and quarter-over-quarter growth in CyPath Lung test volume.
• October 2025 test volume increased by 111% over the 2025 monthly average, indicating accelerating adoption.
• Third-quarter sales volume increased 95% over the prior quarter, demonstrating strong sequential growth.
• Increased adoption by physicians, pulmonologists, health systems, and VA medical centers, validating clinical value.
• CyPath Lung's strong clinical study results (92% sensitivity, 87% specificity, 88% accuracy) support its effectiveness in early lung cancer detection.
• The company anticipates the upward trend in sales volume to continue, aiming to change the standard of care in early lung cancer detection.

Risks

• The Company's ability to continue to grow CyPath Lung test volume in 2025 and beyond.

Future Outlook

The company expects the upward trend in CyPath Lung sales volume to continue. Management believes that increased physician adoption of CyPath Lung brings them closer to changing the standard of care in early lung cancer detection.

Management Comments

• "The increase in CyPath Lung test volume demonstrates that physicians are increasingly recognizing the clinical value of CyPath Lung in detecting lung cancer at its earliest and most treatable stages." Maria Zannes, President and Chief Executive Officer.
• "This steady adoption of our test underscores the success of our outreach to pulmonologists, health systems, and VA medical centers, as well as the growing trust among clinicians who are incorporating CyPath Lung into the diagnostic pathway for patients with indeterminate pulmonary nodules discovered incidentally or through recommended annual screening for lung cancer." Maria Zannes, President and Chief Executive Officer.
• "We’re proud of the progress made this year and expect the upward trend in sales volume to continue. Each new physician adopting CyPath Lung brings us closer to changing the standard of care in early lung cancer detection." Maria Zannes, President and Chief Executive Officer.

Industry Context

This announcement highlights the increasing demand for non-invasive diagnostics in the early detection of cancer, a critical area in healthcare. The growing adoption of AI-powered tools like CyPath Lung reflects a broader industry trend towards more precise, accessible, and less invasive diagnostic methods, particularly for diseases such as lung cancer where early detection significantly improves patient outcomes and survival rates.

Comparison to Industry Standards

• CyPath Lung demonstrated strong clinical performance with 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small lung nodules (<20mm). The filing does not provide specific comparable companies, projects, or results for direct industry benchmarking.

Stakeholder Impact

• Shareholders: Positive impact due to accelerating sales growth and increased market adoption, potentially leading to increased share value.
• Patients: Improved access to early lung cancer detection, potentially leading to better treatment outcomes and increased survival rates.
• Physicians/Healthcare Providers: Provides a valuable non-invasive diagnostic tool for early lung cancer detection, aiding in clinical decision-making.
• Employees: Positive impact from company growth and product success, potentially leading to job security and opportunities.

Next Steps

• Continue efforts to grow CyPath Lung test volume.
• Maintain and expand outreach to pulmonologists, health systems, and VA medical centers.
• Work towards establishing CyPath Lung as a standard of care in early lung cancer detection.

Key Dates

Recommendation

The filing indicates robust and accelerating sales growth for CyPath Lung, a non-invasive diagnostic with strong clinical performance (92% sensitivity, 87% specificity, 88% accuracy). The significant increase in test volume (111% over monthly average in October) and physician adoption suggests strong market penetration and validation of the product's clinical value. This operational momentum, coupled with the potential to change the standard of care in early lung cancer detection, positions bioAffinity Technologies for continued growth and makes it an attractive investment.

Keywords

Lung cancer, noninvasive diagnostic, CyPath Lung, biotechnology, early detection, AI, flow cytometry, sputum test, BIAF, diagnostics