BeVigilant™ OraFusion™ System For Oral Cancer Intervention
Next-generation biomarker screening for early oral cancer detection.
Oral Cancer Detection With BeVigilant™ OraFusion™
Using advanced, non-invasive biomarker analysis, the device tests for p16 and EGFR protein markers from a small saliva sample. This dual-biomarker methodology, combined with each patient’s personalised clinical risk profile, enables accurate stratification and removes the guesswork traditionally associated with evaluating suspicious oral lesions.
With chairside results in 15 minutes or less, the system delivers an immediate, validated risk outcome: “Monitor” or “Investigate Further”. This allows clinicians to define the next step instantly, avoiding delays linked to external laboratory testing. The result is a smoother clinical workflow, reduced operational cost, and, most importantly, accelerated access to specialist investigation for patients presenting with elevated risk.
Need more info?
For further questions about this product:
Get in touch
Why Choose OraFusion™?
- Objective Confidence: Replace subjective visual screening with data-driven, highly accurate risk assessment with 90-100% accuracy.
- Rapid Chairside Results: Deliver validated risk scores in 15 minutes or less, enabling immediate patient action and next-step planning.
- Dual-Biomarker Advantage: Leverage advanced science by analysing two critical protein biomarkers for enhanced diagnostic precision.
- Enhanced Patient Safety: Improve patient care by facilitating the earliest possible detection and referral pathway for oral cancer and pre-cancerous lesions.
- Streamlined Workflow: Integrate seamlessly into existing patient appointments, reducing administration and eliminating the time delay of external lab processing.
- Revenue Growth Opportunity: Introduce a high-value, medically necessary screening service that diversifies your offering and increases patient throughput.
Watch OraFusion in Action
Who Is the OraFusion™ System For?
Ideal for clinics such as:
- Dental practices seeking to strengthen routine oral cancer screening protocols.
- Clinics supporting high-risk patients, including smokers, heavy alcohol users, or individuals with persistent oral changes.
- Oral medicine and oral surgery teams managing complex or ambiguous lesions.
- ENT and head & neck specialists requiring deeper patient insight during assessments.
- Multidisciplinary medical clinics focused on early detection and preventative care.
- Practices seeking point-of-care decision support to reduce unnecessary referrals and accelerate specialist pathways.
Simple, 3-Step Analysis
The OraFusion System is designed for seamless, rapid integration into your routine patient consultation, providing a definitive risk assessment within minutes using a straightforward, non-invasive protocol. This simplicity ensures maximum patient comfort and efficiency, allowing your clinical team to focus entirely on diagnosis and next-step planning without complex procedural bottlenecks.
1. Collect Saliva Sample
A small, non-invasive saliva sample is collected from the patient using the single-use Ora-3D collection device. This process is performed chairside and requires minimal time.
2. Test & Analyse
The collected sample is applied to the Ora-3D test cassette, which is then inserted into the BeVigilant Reader. The Reader combines the quantitative biomarker results with the patient’s clinical risk factors using its proprietary sensor fusion algorithm.
3. Instant Risk Report
In 15 minutes or less, the system generates a clear, objective risk assessment: “Monitor” or “Investigate Further”. This actionable data allows your clinician to immediately counsel the patient and determine the optimal pathway for follow-up or specialist referral.
Clinical Outcomes
The OraFusion System eliminates the ambiguity of visual inspection by delivering a definitive, clear result designed to immediately guide your clinical action. This binary classification empowers your practitioners to confidently manage the patient pathway, placing your clinic at the forefront of early detection and improving assessment accuracy. All results are securely stored and managed via the Vigilant Cloud Platform, facilitating robust, longitudinal patient record-keeping and seamless ongoing care.
Monitor
This result suggests that, based on the combined biomarker and clinical risk data, there is no immediate need for specialist referral. You can confidently continue with routine patient management and scheduled follow-ups.
Investigate Further
This result strongly suggests the necessity of specialist referral for further comprehensive evaluation. This ensures patients with elevated risk receive accelerated access to definitive diagnosis and care.
How the OraFusion™ System Works
Dual-Biomarker Saliva Analysis
Immunoassay Signal Detection
Real-Time Classification
Integrated Risk Profiling
Speak to Our Team
Speak to a Team Member
Speak to one of our team members about the devices available at AMP.
Why Early Oral Cancer Detection Matters
Early detection remains the single most influential factor in improving survival rates and reducing the severity of treatment for oral cancer. Many early-stage lesions present with subtle or ambiguous visual characteristics, making them difficult to interpret through examination alone. By identifying molecular changes before they progress into clinically evident disease, practitioners can intervene sooner, streamline referral pathways, and offer patients significantly improved long-term outcomes.
Delays in diagnosis often lead to late-stage presentation, where treatment becomes more invasive, recovery is prolonged, and prognoses decline sharply. Integrating an evidence-driven screening tool like the OraFusion™ System into routine assessments enhances diagnostic certainty and supports more proactive patient management, ultimately improving the standard of care within modern clinical settings.
BeVigilant™ OraFusion™ FAQs
How does the OraFusion™ System improve early oral cancer detection?
The system enhances early detection by identifying molecular changes linked to malignant transformation before they present visibly. By analysing two key salivary biomarkers, it provides an objective risk assessment that supports earlier intervention and strengthens clinical decision-making in cases where visual examination alone may be inconclusive.
What biomarkers does the OraFusion™ System measure and why?
OraFusion™ measures p16 and EGFR, two protein biomarkers associated with abnormal cell-cycle activity and tumour-related signalling pathways. These markers are clinically relevant because their altered expression can indicate early-stage changes commonly seen in oral and oropharyngeal cancers.
How accurate is the dual-biomarker approach compared to visual assessment alone?
Visual assessment can be limited when lesions appear subtle or ambiguous. The dual-biomarker model increases diagnostic confidence by combining molecular insight with clinical context. This reduces reliance on subjective interpretation and offers a more sensitive and specific method of identifying lesions that may require further investigation.
Is the OraFusion™ test painful or invasive for patients?
No. The test uses a small sample of whole saliva, collected comfortably and non-invasively at the chairside. There are no needles, swabs, or tissue disruption involved, making it suitable for a wide range of patients.
How long does it take to obtain results from the system?
OraFusion™ provides a validated risk category in approximately 15 minutes, enabling clinicians to discuss findings and plan next steps within the same appointment.
Can the OraFusion™ System be used during routine dental check-ups?
Yes. The system is designed for seamless integration into routine appointments, making it suitable for screening patients who present with suspicious lesions or who fall into higher-risk categories during standard examinations.
Does the test replace the need for biopsy or specialist referral?
No. OraFusion™ is an adjunctive screening tool, not a diagnostic replacement. A high-risk result indicates the need for urgent referral or further diagnostic procedures, including biopsy, in line with existing clinical pathways.
Are the results affected by eating, drinking, or oral health conditions?
Certain factors can influence saliva composition. Clinics are advised to follow the manufacturer’s pre-test guidelines to ensure optimal accuracy, such as allowing a short interval after eating or drinking. When used correctly, the test is designed to deliver consistent, reliable results.
How does OraFusion™ integrate into existing diagnostic workflows?
The system fits naturally into standard examination protocols, requiring only a brief saliva collection and automated reader analysis. It enhances current workflows by offering objective molecular data without extending chair time or disrupting routine processes.
Is the system suitable for screening high-risk patient groups?
Absolutely. Patients who smoke, consume alcohol heavily, or present with persistent or atypical oral changes benefit significantly from this enhanced level of screening. OraFusion™ supports earlier detection in individuals who may otherwise progress without clear clinical signs.
Book a demo
If you have any further questions or would like to arrange a demo of our OraFusion™ by BeVigilant™ device, contact Aesthetic Medical Partnership
Call 01727 482 432