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 patient stigma significantly impact decision-making and follow-up.

• Current risk calculators often provide inconsistent recommendations, complicating clinical decisions.

• Referrals come from diverse sources, including oncology, primary care, and cardiology, with variable patient risk profiles.

Role and utility of CyPath Lung

• CyPath Lung is used for risk stratification, especially in nodules not clearly indicated for biopsy.

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

• Helps guide decisions on whether to proceed with biopsy or surveillance, reducing unnecessary interventions.

• Offers peace of mind to patients and clinicians, especially when results are negative.

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

Case studies and clinical impact

• CyPath identified early invasive adenocarcinoma in a patient with ambiguous imaging, leading to timely intervention.

• Enabled diagnosis and treatment in reluctant or high-risk patients who otherwise would have delayed care.

• Provided a non-invasive diagnostic option for patients unsuitable for anesthesia or invasive procedures.

• Helped manage patient anxiety during surveillance and follow-up periods.

• Demonstrated reliability even in regions with high endemic fungal disease.