Early Results of Clinical Trial with nsCanary: Digital ROSE Device for Bronchoscopic Biopsy Evaluation

Lung cancer (LC) diagnosis relies on bronchoscopic biopsies followed by pathology assessment. This method has a non-diagnostic rate of up to 40%, which leads to delayed diagnoses. NovaScan has developed nsCanary, a digital version of Rapid On-Site Evaluation that detects cancer using a biomarker based on the Cole Relaxation Frequency. This study aims to assess the diagnostic performance of nsCanary (Figure 1). In an IRB-approved study, data were collected from 20 patients (9 males and 11 females with an average age of 64.2) undergoing bronchoscopies at the Pentax Training Center, Ecuador. Each biopsy sample was positioned on a disposable scanning electrode for a spectral impedance measurement. Subsequently, a proprietary algorithm generated the CRF biomarker to differentiate between cancerous and non-cancerous samples. LC assessment provided by nsCanary was validated against pathology outcomes for each biopsy. 14 cases were confirmed with a final diagnosis of neoplasia (11 adenocarcinomas) for n= 20 patients. Compared to the definitive diagnosis, findings from the nsCanary show a sensitivity of 90%, specificity of 70%, NPV = 87.5%, and PPV = 75%. The integration of the nsCanary device into the clinical workflow will enhance decision-making by providing immediate cancer detection feedback, reducing the non-diagnostic rate, and aiding clinicians in confirming cancer presence during the first biopsy. <fig><object-id>erj;64/suppl_68/PA1542/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig> nsCanary