Bevigilant Orafusion System

Bevigilant Orafusion Reader:

The BeVigilant™ Reader is intended to be used only with the Ora-3D. The BeVigilant OraFusion System is intended to be used by qualified health-care providers as a prediagnostic test on symptomatic adult patients, specifically those with oral mucosal abnormalities visible to the health-care provider, during the oral cancer exam and risk assessment. The BeVigilant^TM Reader is an advanced immunochromatography reader which captures the test data and provides the results during the patient’s visit. The BeVigilant™ Reader provides the summary of the combined test result with clinical risk factors to assess oral abnormalities in patients with lesions.

BeVigilant^TM Ora-3D:

The Ora-3D is a point-of-care semi-quantitative immunoassay consisting of a single use lateral flow test that measures p16 and EGFR in saliva, which are known to be associated with oral cancer. The Ora-3D is intended to be used with the BeVigilant™ Reader.

This early detection test achieves a sensitivity of 100% and a specificity of 94%.

EGFR (a tyrosine kinase receptor from the ErbB family) is an oncogene that has been identified in a number of malignancies, including cancer of the breast, prostate, pulmonary system, bladder, and head and neck.

p16 positive oropharyngeal SCC has a very favourable prognosis, regardless of the HPV status of the tumor. This argues that HPV-specific tests add little to the clinical information provided by p16.

The BeVigilant™ OraFusion™ System identifies the presence of biomarkers associated with oral cancer in 15 minutes or less through saliva sample.