bioAffinity Technologies (BIAF) Status update summary

Clinical challenges in pulmonary nodule assessment

• Increasing screening and expanded high-risk definitions are driving a surge in pulmonary nodule detection, creating a significant clinical burden for pulmonologists and related specialists.

• Risk stratification is essential, as not every nodule or patient requires invasive procedures; tools like CyPath Lung help inform these decisions.

• Anxiety, stigma, and patient reluctance are common, with many patients apprehensive about both the diagnosis and the procedures.

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

Role and utility of CyPath Lung

• CyPath Lung is used as a non-invasive, sputum-based test to risk-stratify patients with pulmonary nodules, especially when traditional models or imaging are inconclusive.

• The test is particularly valuable for nodules under 20 mm, offering a 92% sensitivity and 99% negative predictive value, aiding in clinical decision-making.

• CyPath can be used both upstream (before biopsy) and downstream (after inconclusive biopsy) to guide further management.

• The test is simple for patients, can be performed at home, and helps reduce anxiety by providing actionable data.

Case studies and clinical outcomes

• Case examples highlighted CyPath's role in identifying early-stage lung cancer in patients with ambiguous imaging or high procedural risk.

• CyPath results have influenced decisions to proceed with or defer biopsies, and in some cases, led to early intervention and improved outcomes.

• The test has been used successfully in patients with prior cancers, small nodules, and those unable to undergo invasive procedures.