Oral cancer represents a significant global health challenge, affecting hundreds of thousands of individuals each year. Identifying this disease in its earliest stages is crucial for improving patient outcomes. Fortunately, advancements in medical technology are offering new possibilities for early detection.
The Urgency of Early Oral Cancer Detection
Detecting oral cancer early significantly influences a patient’s prognosis. Many oral cancers are identified at advanced stages, often after the disease has spread. This late diagnosis is challenging because initial symptoms can be subtle and mistaken for less serious conditions, leading to delays in seeking medical attention.
The average time to diagnosis for oral cancer can be over 100 days, often due to patients not recognizing early signs. When oral cancer is diagnosed at a localized stage, the five-year survival rate is around 86.3%. However, this rate drops significantly to about 40.4% if the cancer has spread to distant parts of the body. This difference underscores the pressing need for earlier identification methods.
Vigilant Biosciences’ OraFusion System
Vigilant Biosciences has developed the BeVigilant OraFusion System to aid healthcare providers in the early detection of oral cancer. This point-of-care device can be used in clinical settings, such as a dental office, during a routine patient visit. The system utilizes a non-invasive saliva sample.
The process involves collecting a small saliva sample into a disposable cassette, similar to a home COVID test. This cassette is then inserted into a compact reader device. The system processes the sample and provides results within 15 minutes, offering a rapid assessment of a patient’s oral cancer risk. These results, combined with clinical risk factors, guide clinicians in determining whether further investigation or specialist referral is necessary.
The Scientific Basis of Detection
The OraFusion System detects oral cancer by analyzing specific biological indicators, or biomarkers, in saliva. Biomarkers are measurable substances in the body that can indicate disease. The system focuses on transmembrane and proteomic biomarkers. Transmembrane biomarkers are proteins shed by cell membranes, and their presence can signal rapid cell reproduction, which is a characteristic of cancer.
The system also identifies proteomic biomarkers, which are proteins whose concentrations increase when tissue becomes cancerous. Specifically, the OraFusion System detects p16 and EGFR, both associated with oral cancer. The device also includes a control to measure the viability and amount of the saliva sample. The system integrates data from these biomarkers with clinical risk factors, such as age, tobacco and alcohol use, and gender. This information is then analyzed by machine-learning software to enhance the accuracy and efficiency of the diagnostic process, providing a semi-quantitative risk assessment.
Transforming Patient Outcomes
The BeVigilant OraFusion System holds promise for improving patient outcomes in oral cancer. Identifying oral cancer early can lead to less invasive treatment options, which generally result in better quality of life and significantly higher survival rates. For instance, early detection can increase the five-year survival rate to over 90%, compared to the current overall rate of 50-60%.
Vigilant Biosciences’ commitment to early detection has been recognized through the FDA Breakthrough Device designation for the BeVigilant OraFusion System in March 2023. This designation acknowledges the product’s unique potential to provide a more effective diagnosis for serious conditions. While pending FDA approval in the U.S., the device is already available and being used in international markets, including Germany, Italy, and the UK, with plans for further global expansion into regions like the Middle East, Turkey, Thailand, Singapore, Hong Kong, and Malaysia. This global reach aims to make advanced oral cancer detection accessible worldwide.