As a pioneer in early oral cancer detection solutions, Vigilant Biosciences® strives to help clinicians diagnose oral cancer in Stages I and II to accelerate treatment initiation and improve patient outcomes. Our team leverages decades of specialized clinical expertise and healthcare leadership to develop groundbreaking technologies that revolutionize oral cancer detection and, ultimately, save lives.

Why Early Detection Is Crucial

Oral cancer poses a significant threat to public health. With more than 744,000 cases each year worldwide1 and less than a 50% five-year survival rate2, oral cancer outcomes are exceedingly poor — but could be improved with proactive screening and early detection. When oral lesions go undiagnosed, per the common practice of “waiting-and-watching,” patients often face a late-stage oral cancer diagnosis. In fact, it is estimated that more than two-thirds of oral cancers are diagnosed in Stages III and IV.3

For most, survival requires extensive reconstructive surgery, prostheses, chemotherapy, radiation, and years of rehabilitative therapy to regain physical function and maintain oral health. If patients are diagnosed in Stages I and II, they not only have a higher chance of survival, estimated to be 80-90%, but can also avoid major surgery, long recovery times, and the rapidly growing costs of cancer care.

Where Traditional Screening Methods Fall Short

Historically, standard oral cancer screening methods, such as visual examinations and palpation, played a central role in identifying suspicious lesions. However, these methods are often incapable of detecting preliminary malignancies, even with early-stage signs and symptoms. Visual inspections can easily miss early, subtle changes, while palpation typically fails to detect abnormalities located beneath the mucosal surface. The inherent subjectivity in detection methodologies results in delayed diagnosis and substantially worse outcomes.

Introducing the BeVigilant™ OraFusion™ System

After years of testing and development, Vigilant Biosciences® has taken a major step forward in oral cancer care with the BeVigilant™ OraFusion™ System. As an FDA designated breakthrough device, the BeVigilant™ OraFusion™ System serves as a precise and reliable chairside risk assessment tool, empowering clinicians with the critical information they need to accelerate oral cancer detection with unprecedented accuracy and confidence.

The BeVigilant™ OraFusion™ System unites cutting-edge technology and clinical rigor to change the face of oral cancer screening through:

  • Salivary biomarker identification. As oral lesions become malignant, certain protein-based biomarkers become overexpressed. Vigilant Biosciences® conducted over 14,000 tests to isolate two early-stage salivary biomarkers with complementary detection accuracy.
  • Clinical risk factor analysis. To create a more individualized assessment, the BeVigilant™ OraFusion™ System employs intelligent software-driven analytics to evaluate each patient’s age, sex, race, alcohol consumption, and tobacco use. These results are paired with biomarker identification to provide a highly accurate risk analysis.
  • Objective measurements. The BeVigilant™ OraFusion™ System quantifies the dual analysis of salivary biomarkers and clinical risk factors to produce a highly accurate risk assessment. Each test provides a “low”, “moderate”, or “elevated” result with over 90% sensitivity and specificity.4
  • Easy integration and rapid results. In 15 minutes or less, clinicians can understand a patient’s oral cancer risk to correctly decide whether to refer to a specialist or wait and watch. BeVigilant™ OraFusion™ System seamlessly integrates into standard clinical workflows, making it easier than ever to accelerate detection at the point of care.

1. World Cancer Research Fund International. (2022, April 14). Mouth and oral cancer statistics. WCRF International.
2. González-Moles, M.Á., Aguilar-Ruiz, M., & Ramos-García, P. (2022). Challenges in the Early Diagnosis of Oral Cancer, Evidence Gaps and Strategies for Improvement: A Scoping Review of Systematic Reviews. Cancers 14(19), 4967.
3. Oral and oropharyngeal cancer – statistics. Cancer.Net. (2023, May 9).
4. Landis, G., Mardy, Z., Donovan, M., Nebrigic, D. (2022). Novel Breakthrough OraFusion™ System for Suspicious Oral Lesions Risk Assessment in the Dental Practice [White Paper]. Vigilant Biosciences®.