bioAffinity Technologies (BIAF) Status update summary

Clinical challenges in pulmonary nodule assessment

• Increasing burden of pulmonary nodules due to expanded screening and broader high-risk definitions.

• Risk stratification is essential to avoid unnecessary biopsies and procedures.

• Anxiety and stigma among patients complicate decision-making and follow-up.

• Referral patterns vary, with many cases coming from oncology, primary care, and incidental findings.

• Current risk calculators often provide inconsistent recommendations, highlighting the need for better tools.

Role and utility of CyPath Lung test

• CyPath Lung is used for risk stratification, especially when traditional models are insufficient.

• Provides a non-invasive, sputum-based diagnostic with high sensitivity (92%) and negative predictive value (99%) for nodules under 20mm.

• Helps guide decisions on whether to biopsy, monitor, or reassure patients.

• Useful in both upstream (pre-biopsy) and downstream (post-biopsy) clinical decision-making.

• Offers peace of mind to patients and clinicians, reducing unnecessary interventions.

Case studies and clinical outcomes

• CyPath influenced biopsy decisions in ambiguous cases, leading to early cancer detection and intervention.

• Enabled non-invasive assessment for high-risk or reluctant patients, facilitating appropriate care.

• Provided a solution for complex cases, such as transplant candidates, where invasive procedures are risky.

• Demonstrated reliability in nodules as small as 4mm, supporting its use in small lesion management.