DSOs Could Soon Begin Offering Real-Time Early Cancer Detection

Vigilant Biosciences cites that more than 90% of oral cancers are squamous cell carcinomas. Current 5-year survival rates are less than 50% with over 70% diagnosed at stage III or stage IV.¹ About one-third of patients will have an abnormality that could be early-stage cancer, including leukoplakia, lichen planus, red spots, or white spots. Guessing which abnormality does or does not need follow-up can be challenging. For example, only about 4% of cases of lichen planus turn cancerous, but if that happens, the cancer is aggressive and can quickly become life-threatening

Knowing when to refer a patient to a specialist may not have to rely on visual speculation anymore. Vigilant Biosciences’ BeVigilant™ OraFusion™ uses biomarkers to detect early-stage cancer. The test uses four drops of saliva dropped onto a small cassette, the size of an at-home COVID test, and inserted into a small reader box. A report is generated in 10 minutes. The battery-operated reader boxes can be shared between operatories in multi-practitioner practices. To ensure that each test is usable, a specific biomarker acts as a smart control, checking if the test has enough saliva for a viable sample.

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Many factors determine the likelihood of oral cancer. Clinical risks include gender, age, and tobacco and alcohol use, but the fascinating research behind this technology is centered on proteins that become elevated as tissue becomes cancerous, known as proteomic biomarkers. For example, a transmembrane biomarker detects rapid reproduction of the cells, an indication of cancer. Another biomarker is created as the body tries to fight that rapid cell reproduction. The test analyzes these biomarker activities along with the clinical risk factors and produces a report that can be easily shared with a specialist if an abnormality in the mouth is starting to exhibit cancerous behavior.

To choose the biomarkers that lead to the most effective results, Vigilant’s scientists have studied thousands of biomarkers in the last 4 years to narrow the field to those that best detected early-stage cancers. The test is not necessary for every patient, but every patient who has an orally potential malignant disorder (OPMD) should be tested.

“We have seen a lot of interest from DSOs,” says Bill Brodie, Chief Executive Officer of Vigilant Biosciences. “I think they see it as elevating their practices to be more like health care providers and also as a marketing opportunity for providing this much needed screening.”

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In the United States, this groundbreaking testing technology was granted Food and Drug Administration (FDA) Breakthrough Device Designation in March 2023, and is expected to receive FDA approval in the coming months. FDA breakthrough designation recognizes the product as truly unique under the current standard. Promising pending legislation may open the door for all breakthrough products to get reimbursed through insurance. Brodie noted that after the product gets FDA approval, reimbursement codes used by light-based devices — CDT 04316 (assessment of oral abnormality) — may also be applicable for this new testing method.

Meanwhile, Vigilant has already launched commercially in Germany, Italy, and the United Kingdom, and very shortly will enter the Middle East, Turkey, Thailand, Singapore, Hong Kong, and Malaysian markets. Brodie noted that final registrations for use will soon be granted in India, a country with the largest oral cancer market globally. Use of BeVigilant™ OraFusion™ may help to reduce the biggest cause of cancer among men in India.

This new device brings the point of care directly to the patient, at the same appointment, within minutes. Other cancer-detection testing methods need to be mailed away for a report. The patient then must wait for the result and return to the office, creating both anxiety and inconvenience. Taking the BeVigilant™ OraFusion™ test is “the right thing to do for the patient,” says Brodie. “Regardless of reimbursement or any profit motive, dental practitioners really have a chance to save patients’ lives. It can make a tremendous difference. And that is really our goal.” 

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Reference
1. Vigilant Biosciences. Oral Cancer Risk is Escalating. https://vigilantbiosciences.com/. Accessed May 13, 2024.

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