8-K: CyPath Lung Successfully Detects Early-Stage Neuroendocrine Tumor Missed by Other Diagnostics

bioAffinity Technologies' CyPath Lung noninvasive sputum test successfully identified a Stage 1A neuroendocrine tumor in a patient, a cancer type missed by PET scans, bronchoscopies, and serum tumor markers.

Summary

• bioAffinity Technologies, Inc. announced a new case study where its CyPath Lung test detected a Stage 1A neuroendocrine tumor in a patient's lung.
• The 13mm nodule was initially missed by multiple diagnostic tools, including PET scan (showing low metabolic activity), bronchoscopies, and serum tumor marker tests, which suggested non-cancerous inflammation.
• Risk models initially placed the likelihood of malignancy around 16%.
• Follow-up low-dose CT (LDCT) scans in January and July 2024 were stable, but a new upper respiratory infection in early 2025 prompted repeat imaging, which showed nodule growth.
• A second bronchoscopy also returned no evidence of malignancy.
• The CyPath Lung test, reported on March 4, 2025, returned a high score of 0.72, indicating a high likelihood of cancer.
• Based on the CyPath Lung result, the patient underwent robotic wedge resection in June 2025, and pathology confirmed a Stage 1A neuroendocrine tumor.
• CyPath Lung utilizes proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy, incorporating a fluorescent porphyrin preferentially taken up by cancer and cancer-related cells.
• Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters.

Sentiment

Score: 9

Explanation: The filing presents a highly positive case study demonstrating the efficacy and added value of CyPath Lung in detecting early-stage cancer missed by conventional methods, which is a significant validation for the product and company.

Positives

• CyPath Lung successfully identified a Stage 1A neuroendocrine tumor that was missed by multiple other diagnostic tools, including PET scans, bronchoscopies, and serum tumor markers.
• The test provided clarity and led to appropriate next steps, resulting in the early surgical removal of a potentially life-saving Stage 1A tumor.
• Demonstrates high added value to the diagnostic pathway, especially for difficult-to-detect cancer types like neuroendocrine tumors.
• Clinical study results show high performance: 92% sensitivity, 87% specificity, and 88% accuracy for detecting lung cancer in high-risk patients with small nodules (<20mm).
• CyPath Lung is a noninvasive test, offering a less burdensome option for patients.

Risks

• Actual results could differ materially from current expectations and assumptions.
• Uncertainties regarding the ability of CyPath Lung to consistently indicate a high probability of lung cancer.
• Uncertainties regarding the benefits of adding CyPath Lung to the standard of care for evaluating indeterminate lung nodules.
• Uncertainties regarding CyPath Lung providing clarity when imaging and risk models are inconclusive and when other adjuvant diagnostics are contraindicated.
• Other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including periodic reports on Forms 10-Q and 8-K.

Future Outlook

Forward-looking statements indicate the company believes CyPath Lung can indicate a high probability of lung cancer, offers benefits when added to standard care for indeterminate lung nodules, and provides clarity when other methods are inconclusive or contraindicated.

Management Comments

• "We believe that this patient's experience demonstrates the high added value that CyPath Lung brings to the diagnostic pathway. Multiple procedures and diagnostic tools were inconclusive, failing to identify the 13mm lung nodule as cancer, so when her CyPath Lung test returned a likely cancer result, it clarified appropriate next steps. The end result was surgical removal of a Stage 1A neuroendocrine tumor, a cancer type that can be difficult to detect by imaging and bronchoscopy alone, early enough for potentially life-saving treatment." Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer.
• "We believe that this case underscores CyPath Lung's growing importance as an essential adjunct to low-dose CT scans for patients with indeterminate pulmonary nodules when imaging and traditional tools leave questions unanswered." Maria Zannes, bioAffinity Technologies President and CEO.

Industry Context

This announcement highlights the ongoing challenge in early cancer detection, particularly for difficult-to-diagnose tumors and indeterminate nodules. CyPath Lung positions itself as a valuable noninvasive adjunct to existing imaging and invasive procedures, addressing a critical unmet need in the diagnostic pathway for lung cancer. It aims to improve patient outcomes by enabling earlier and more accurate diagnosis, potentially shifting the paradigm for lung cancer screening and follow-up.

Comparison to Industry Standards

• The case study explicitly states that PET scan, bronchoscopies, and serum tumor marker tests were inconclusive or suggested non-cancerous inflammation, failing to identify the 13mm lung nodule as cancer, contrasting with CyPath Lung's successful detection.
• The filing notes that neuroendocrine tumors can be difficult to detect by imaging and bronchoscopy alone, highlighting CyPath Lung's advantage in such challenging cases.
• Clinical study results for CyPath Lung (92% sensitivity, 87% specificity, 88% accuracy for nodules <20mm) are presented as strong performance metrics for early-stage lung cancer detection, implicitly comparing favorably to the limitations observed in the case study with other standard methods.

Stakeholder Impact

• Shareholders: Positive impact due to strong validation of the company's flagship product, potentially increasing market confidence and share value.
• Patients: Significant positive impact by offering a noninvasive, accurate test for early detection of lung cancer, potentially leading to earlier treatment and improved survival rates.
• Healthcare Providers: Provides a valuable new tool to assist in diagnosing difficult-to-detect lung nodules, improving diagnostic accuracy and patient management.

Next Steps

• Continued marketing of CyPath Lung as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.
• Further integration of CyPath Lung into the diagnostic pathway for patients with indeterminate pulmonary nodules.

Key Dates

Recommendation

The filing provides compelling evidence of CyPath Lung's superior diagnostic capability, successfully identifying an early-stage cancer missed by multiple standard methods. This validation significantly de-risks the product's market potential and highlights its critical role in improving patient outcomes. Such a strong clinical validation for a noninvasive diagnostic tool in a high-need area like lung cancer is a substantial positive catalyst, suggesting strong future revenue potential and market adoption.

Keywords

bioAffinity Technologies, CyPath Lung, lung cancer detection, noninvasive test, early-stage cancer, neuroendocrine tumor, sputum test, biotechnology, diagnostic tools, AI diagnostics, flow cytometry, cancer screening