8-K: CyPath Lung Case Study Shows Reduced Biopsy Need

bioAffinity Technologies' CyPath Lung test successfully guided a non-invasive surveillance strategy for an elderly patient with a suspicious lung nodule, avoiding an unnecessary biopsy.

Summary

• bioAffinity Technologies announced a new clinical case study for its CyPath Lung noninvasive diagnostic test.
• The case involved a 79-year-old female, a current smoker with COPD and coronary heart disease, who had a suspicious half-inch spiculated lung nodule on a low-dose CT scan in June 2025.
• The CyPath Lung test result was negative, supporting a conservative management approach with annual CT screening.
• A repeat CT scan in October 2025 showed the suspicious finding had resolved, with no pulmonary nodules present.
• The case study demonstrates CyPath Lung's ability to provide objective data for risk stratification, helping physicians avoid unnecessary and potentially risky invasive procedures like biopsies.
• CyPath Lung has previously shown 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small indeterminate lung nodules less than 20 millimeters.

Sentiment

Score: 8

Explanation: StockSavvy.ai views this as a strong positive development, as a successful clinical case study provides real-world validation for CyPath Lung, potentially increasing physician adoption and market confidence in the company's core product.

Positives

• CyPath Lung successfully supported a recommendation for a surveillance strategy, avoiding an invasive, risky, and costly biopsy for an elderly patient.
• A repeat scan validated the decision made with CyPath Lung's results, showing no nodules in the lungs after an initial suspicious finding.
• The noninvasive CyPath Lung test has demonstrated high performance with 92% sensitivity, 87% specificity, and 88% accuracy for detecting lung cancer in small nodules less than 2 centimeters.
• The test provides objective data to better stratify risk, offering confidence to defer invasive procedures and putting patients at ease with ongoing surveillance.
• CyPath Lung complements imaging findings in high-risk individuals.

Risks

• Actual results could differ materially from current expectations due to various risks and uncertainties.
• Risks include the ability of CyPath Lung to indicate a high probability of lung cancer.
• Risks include CyPath Lung providing confidence in a proposed course of action for high-risk patients with spiculated nodules.
• Risks include the ability of CyPath Lung to determine if cancer is present or if the patient is cancer-free.
• Other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent SEC filings.

Future Outlook

The company believes its forward-looking statements are reasonable, but cautions against undue reliance. It does not undertake to update any forward-looking statements except as required by law. The statements relate to the potential for CyPath Lung to indicate high probability of lung cancer, provide confidence in treatment courses, and determine cancer presence.

Management Comments

• "Given this patient's age, smoking history and comorbidities, we were not comfortable proceeding directly to an invasive procedure. CyPath Lung gives us objective data to better stratify risk and avoid putting our patients through unnecessary and potentially risky procedures." Daya Nadarajah, MD, the patient's pulmonologist.
• "Every suspicious finding is concerning. Even when the probability of malignancy is low, the consequences of missing a cancer are significant. Physicians now have a tool in CyPath Lung that further refines risk and provides valuable reassurance when deciding whether to monitor or escalate care." Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer.

Industry Context

StockSavvy.ai notes that this case study reinforces the growing trend towards non-invasive diagnostic tools in oncology, particularly for high-risk patient populations where invasive procedures carry significant risks. The ability to confidently defer biopsies based on objective data from tests like CyPath Lung aligns with efforts to reduce healthcare costs and patient burden, a key focus in modern healthcare.

Comparison to Industry Standards

• The 92% sensitivity, 87% specificity, and 88% accuracy for detecting lung cancer in small nodules (<20mm) positions CyPath Lung favorably against other non-invasive lung cancer screening methods, which often struggle with high false-positive rates leading to unnecessary follow-up procedures.
• For instance, traditional sputum cytology has significantly lower sensitivity (often below 50%) for early-stage lung cancer detection.
• While LDCT is the gold standard for screening, its high false-positive rate (up to 96% in some studies) often necessitates further invasive procedures, which CyPath Lung aims to reduce.
• Other emerging liquid biopsy or breath tests are still in various stages of development or commercialization, and CyPath Lung's demonstrated performance in a real-world case study provides a strong competitive advantage in the non-invasive diagnostic space.

Stakeholder Impact

• Shareholders: Positive impact due to validation of a key product, potentially leading to increased market confidence and future revenue.
• Patients: Significant positive impact by offering a noninvasive option that can reduce the need for risky and costly biopsies, improving patient comfort and care.
• Physicians: Provides a valuable tool for better risk stratification and clinical decision-making in managing patients with suspicious lung nodules.
• Healthcare System: Potential to reduce healthcare costs associated with unnecessary invasive procedures.

Next Steps

• Continue with serial annual CT scans as follow-up care for the patient in the case study.
• Further development and commercialization of CyPath Lung as a Laboratory Developed Test (LDT).

Key Dates

Recommendation

The successful clinical case study provides compelling real-world validation for CyPath Lung, demonstrating its ability to significantly improve patient care by avoiding unnecessary invasive procedures while maintaining high diagnostic accuracy. This positive outcome, coupled with the strong performance metrics (92% sensitivity, 87% specificity, 88% accuracy), positions bioAffinity Technologies favorably in the growing non-invasive diagnostics market. The reduction in diagnostic burden and cost for high-risk patients represents a substantial value proposition, suggesting strong potential for increased adoption and future revenue growth, making it a strong buy for investors.

Keywords

bioAffinity Technologies, CyPath Lung, Lung Cancer, Noninvasive Diagnostic, Early Detection, Biotechnology, LDCT, Sputum Test, Flow Cytometry, Artificial Intelligence, Cancer Screening, Medical Device, Biopsy Avoidance