Most dentists screen for oral cancer during routine checkups. They typically do a visual examination for white patches, sores, or lumps on the cheek lining, floor and roof of the mouth, gums, lips, tongue, and tonsils. Treatments for oral cancer, using special dyes or fluorescent light, have improved over time but often the challenge is detecting oral cancer early, before it has a chance to grow or spread. A new device called the BeVigilant™ OraFusion™ System by Vigilant Biosciences® shows promise in helping dentists find oral cancer in its earliest stages.
According to a 2023 update on pharmacological treatment, oral cavity squamous cell carcinoma (OCSCC) is the most common type of head and neck cancer. It is considered aggressive, with recent epidemiology data published by the National Cancer Institute (NCI), showing the overall survival rate in a 5-year period at 63% with a range between 83% in early stages and 38% in advanced stages. But, it is curable if identified and treated at an early stage.
With oral cancer, if a painless mucosal (inside surface of the mouth) lesion is found, the standard practice calls for a “wait-and-watch” approach, but by the time symptoms become worse, and then the appropriate course of treatment is determined, patients have likely entered the later stages.
Challenges of Traditional Screening
Oral Surgeon Dr. William Shepard is one of the beta testers of a new screening tool that can detect oral cancers earlier. He has training as a bioengineer, surgeon, oral surgeon, and physician and practices at Piney Point Oral and Maxillofacial Surgery in Houston, Texas. He explains that previously, “My screening regimen (which is the current standard in dental practice) was just based off of clinical presentation and clinical history.”
He hadn’t invested in technologies such fluorescence (shining a blue light to illuminate a questionable area, which will appear dark brown if cancer is present) because he says that often, “they’re extremely non-specific and pick up any kind of vascularity.”
Using Biomarkers in Saliva for Detection
Dr. Shepard’s interest in more detailed technologies drove him to become a tester for BeVigilant.
“It’s something that I actually have been finding useful for my practice. Because it’s based on genetic markers, it’s more specific,” he said.
When oral lesions become malignant, cancerous cells overexpress certain protein-based biomarkers. Bill Brodie, Chief Executive Officer of Vigilant Biosciences, noted that after years of looking into thousands of biomarkers and performing nearly 14,000 tests, Vigilant Biosciences isolated distinct biomarkers associated with early-stage oral cancer. He said, “In all of our studies and trials, at least 50% of the cohort was early stage, or pre-cancer stage zero.”
Each biomarker has a job to accomplish, and the relationship between these types of information produces the accuracy.
- The first biomarker measures the amount of the saliva and the viability of the sample.
- The second, a transmembrane biomarker, detects rapid reproduction of the cells, a hallmark of cancer. This biomarker is shed by the cell membrane as the cells reproduce.
- The third biomarker is the body’s attempt to suppress that activity.
The cassette for the test looks similar to home COVID tests. The dentist or hygienist puts four drops of saliva on each side. The cassette is inserted into a little drawer of a reader, which generates a report. It takes about 10-15 minutes to get a result, as the reader measures the concentration of proteins that become elevated as tissue becomes cancerous.
The saliva test results are combined in an intelligent machine-learning software along with the person’s clinical risk factors such as gender, age, tobacco and alcohol use.
“The report shows the concentration of the biomarkers signifying that the abnormality in the mouth is starting to exhibit cancerous behavior,” said Brodie. For some cancers, a speedy diagnosis is vital. “A good example is lichen planus (which may appear as white, lacy patches, red, swollen tissues, or open sores). There is a less than a 4% chance of lichen planus turning cancerous. But if it does, it is very aggressive, and the patient can be dead in 18 months.”
Dr. Shepard added, “In dentistry we have an entity called ‘leukoplakia of indeterminate significance.’ We used to think of leukoplakia as white plaque, but now, specifically in that subset, we’re seeing more cancerous outcomes. So now we are thinking, ‘Does this somehow represent a pre-malignant condition?’ This is where I found the BeVigilant helpful. If the biomarker test shows high risk, I will do a biopsy. If it comes back as low risk, I feel better about just doing routine surveillance.”
“The results are easily understandable,” said Dr. Shepard. “For the general dentist, I think it really helps to determine whether or not they actually need to escalate care to a specialist.”
“The downside to any kind of diagnostic procedure is putting the patient through unnecessary procedures, like an oral biopsy,” said Dr. Shepard. “While oral biopsies are easy to do, I realize that for the patient there is an investment of time, money, and potential risks.”
Achieving FDA Breakthrough Device Designation
In the U.S., the BeVigilant™ OraFusion™ System has been Granted FDA Breakthrough Device Designation and is expected to receive FDA approval in the coming months. It has already launched commercially in Germany, Italy, and the UK and very shortly is expected to debut in India, the Middle East, Turkey, Thailand, Singapore, Hong Kong, and Malaysia.
Kristi Valentine, Customer Success Manager at Vigilant Biosciences said, “We’re constantly taking feedback from our doctors, like Dr. Shepard, to improve and keep it moving forward toward FDA approval in the U.S..”
Detecting oral cancer through biomarkers is a positive step for early detection. Dr. Shepard said, “It’s one of the first steps towards oral genomic medicine. We’re actually checking genomic data for high risk features, and I want to see it succeed, because if this is the starting point, I believe this technology is going to be able to be employed in a multitude of ways, perhaps for detecting gastrointestinal cancers through saliva, in the future, with some tweaking for what is being tested and how that data is gathered.”
Early detection is key to survival. Dentists can take some of the bite out of cancer for their patients with this more specific type of testing technology.
