Today’s oral cancer detection products typically rely on revealing abnormalities or detecting HPV. Yet these tests aren’t necessarily accurate or timely, discovering dangers sometimes long after they are underway. Driven by a passion for science and personal challenges, Matthew Kim believes dentists can do better.
“It’s that standard of care that’s so lacking that hasn’t impacted the high mortality rates that have existed for decades. That contributes to the late-stage intervention that causes 40% to 50% mortality with late-stage treatment,” he said.
Kim is the founder, chair, and CEO of Vigilant Biosciences. Its OncAlert Oral Cancer Risk Assessment System uses protein biomarkers to identify patients’ risk for developing the disease. Its swish-and-spit procedure is as easy as a pregnancy test too, requiring little training or time during a typical dental checkup.
Its simple potential for early detection could have a huge influence on reducing the suffering of those diagnosed with oral cancer, which total 45,750 each year in the United States, says the Oral Cancer Foundation. When caught early, oral cancers have a survival rate of 80% to 90%. But the trick lies in that early detection.
“There’s no symptom of oral cancer per se. It could be a lesion. It could be a trauma from a coffee burn or you biting into your cheek. It could be ill-fitting dentures, hoarseness of the throat or voice, or bad breath,” Kim said. “As a result, it often gets overlooked or misdiagnosed. So when they realize it’s cancer, more often than not, 2 out of 3 times, they’re catching it a late stage, stage 3 or stage 4.”
According to Kim, the OncAlert Oral Cancer Risk Assessment System is the first and only test that uses a tumor-initiating biomarker to assess the early development of oral cancer specifically, accurately, and cost effectively, as opposed to uncovering other oral health issues such as an infection or trauma.
“You have the light-based systems. There’s a variety of them on the market and coming onto the market. They provide an enhanced view of what can be visible. But it does not tell you if what you are seeing is a leukoplakia, trauma, or oral cancer,” Kim said. “As a result, they are very poor in their accuracy for objective assessment of an oral cancer developing in the mouth.”
Kim sees flaws in other detection systems as well. For example, he says that salivary and lab-based tests only detect HPV without telling if that infection is going to develop into cancer. Other tests require lesion validation, but dentists must find those lesions first, again failing to meet the unmet need for early validation.
The OncAlert Oral Cancer Risk Assessment System comprises 2 components: the qualitative Rapid Point-of-Care (POC) Risk Assessment Test and the quantitative CD44 + Total Protein Lab Test (Lab Assay). Dentists and hygienists can administer either test prior to other treatment during a routine checkup. Patients swish a saline solution for 5 seconds, gargle for 5 seconds, and spit into a cup.
When personnel are administering the POC Risk Assessment, they insert a test strip into the cup. Within minutes, the strip produces a color change that shows whether or not the patient has the biomarkers indicating risk of oral cancer.
“We don’t want to obsolete the conventional oral exam, which dentists still need to continue to do,” said Kim. “But our test can elevate and be disruptive in what it can do, but it’s very minimally disruptive in the fact that it can be seamlessly integrated into the current protocol in a clinician’s office.”
If the POC Risk Assessment shows the potential for oral cancer, the dentist will direct the patient to see a specialist like an oral surgeon or an ENT physician who will use the Lab Assay. There, the patient will rinse and spit the solution again. The physician then will send the solution to a reference lab.
“The reference lab will actually give you the exact concentration of our biomarkers,” Kim said. “They can tell the patient that they’re at, for example, twice or 5 times the likelihood or 10 times or 25 times the likelihood of developing oral cancer.”
The system is not a diagnostic tool, Kim notes. However, he does say that it can be a very useful tool for avoiding behaviors that put patients at risk for oral cancer. Its physical evidence of biomarkers could inspire patients to cut back on tobacco and alcohol consumption, for example, or practice safer sex.
“We have some data where interventions such as a smoking cessation program actually reduced the levels of these biomarkers and therefore reduce your likelihood of developing oral cancer,” he said. “We also have data that shows that if you increase healthy lifestyle habits such as eating a green, leafy salad once a day, that will also help you reduce those biomarker levels.”
Later this year, Vigilant Biosciences will publish its data as part of its CE studies. Kim cites encouraging results from the University of Miami, which tested the biomarkers on close to 500 patients to date reflecting more than 15 years of research. The proof of concept studies have produced specificity as high as 95%, which indicates a 5% false positive rate, and sensitivity of about 88%, or a false negative rate of about 12%.
“We’re very excited about the accuracy of the test, especially when you compare that to the standard of care, which is far below that. When you look at the other adjuncts and their ability to specifically and accurately assess oral cancer risk versus a lesion or HPV or an abnormality, ours is far and away the superior product,” he said.
Patients who go to their dentist expecting a cleaning and get surprised by a positive biomarker reading should not panic, though. For example, if there’s a physical or visual symptom along with the biomarker indication, patients would follow up with a specialist. If it is positive with no physical or visual symptom, patients would be asked to return in one to 3 months, depending on their clinical presentation.
“And if they are a tobacco user or a heavy drinker, we would provide some information to encourage them to adopt more healthy lifestyle choices so that they may reduce their level of risk of possibly developing oral cancer,” Kim said.
Kim is familiar with how an unhealthy lifestyle can lead to such as diagnosis. Both of his parents were oral cancer survivors. His father didn’t have an HPV infection, but he was a lifelong smoker and drinker, passing away earlier this year. These habits, Kim said, exponentially increased his odds for developing the disease.
“But he was also a poster child for early detection,” Kim said. “He found it early and they were able to treat it, and he only had to undergo one round of treatment. The result of that was very successful, and he lived 15 great years as a result of that early intervention.”
His mother’s story, though, was perhaps more compelling in his drive to found Vigilant Biosciences and develop a detection system. She is currently a 5-year survivor of oral cancer.
“She was not a tobacco user or drinker. She was not infected with HPV. If anything, she was a chronic secondhand smoker,” he said. “Unfortunately, like most people who find out they have oral cancer, hers wasn’t really identified until it was a late stage.”
As a result of that late diagnosis, she had to undergo several rounds of aggressive treatment, including chemotherapy, radiation, surgery, and reconstruction. Kim witnessed first-hand how the disease and its treatment affected her ability to speak and eat, in addition to the social stigma of reconstruction.
“It’s a new normal, and it requires a major adjustment to do a lot of the things that we take for granted every day—the inability to speak, eat, drink the things that we want, to smile, and to just interact socially the way that we do on an everyday basis,” he said.
Surprisingly, Kim is not a dentist or a doctor. He is an attorney with a bachelor’s degree in biology from Washington University in St. Louis and a JD from Georgia State University. During college, though, he was fascinated by science and medicine as well as their research and application.
“When I went into law school, I had a very strong interest in intellectual property,” he said. “I started off interning my way through law school at the tech transfer office at the Centers for Disease Control and Prevention (CDC), and that was a great nexus between business law and science.”
During his tenure with the CDC, Kim worked on a novel drug platform that converted high-end biologics into an aerosol that could be used to deliver them very efficiently to the lungs. After leaving the CDC and entering the private sector, he licensed out the technology and launched a startup called AerovectRx.
Kim also was the founder of IP Guidance, a strategic intellectual property asset management consulting group. Additional medical commercialization experience includes the development of a point-of-care continuous glucose monitor, a noninvasive bilirubin detection for jaundice, a noninvasive diabetes screening system, and a novel imaging technology for cervical cancer screening.
Vigilant Biosciences, however, is only just beginning. Kim says that the company has data indicating its biomarkers can be leveraged as a platform for detecting other cancers that have common risk factors such as tobacco use, alcohol consumption, and HPV, and it is looking to develop that pipeline in its long-term corporate development.
“We are an oncology-focused company, really focusing on early intervention and enabling early intervention and detection for improving outcomes,” he said.
As for the OncAlert Oral Cancer Risk Assessment System, Vigilant Biosciences is in close discussions with the Food and Drug Administration and is exploring a variety of opportunities and go-to-market strategies depending on the claims that it would like to make. It already has distribution deals in France, Algeria, Morocco, Tunisia, Scandanavia, Korea, and New Zealand.
“Our current path shows that we will have the Lab Assay on the market in 2016. We hope to have our Point-of-Care Assay shortly after that,” he said.
Education will be a challenge, though. Vigilant Biosciences conducted a survey of 1,050 US consumers and found that 68% knew little or nothing about oral cancer, and only 36% were screened during their last dental checkup. Yet the survey also found that consumers want to learn more about how to prevent oral cancer and are interested in simple, effective screening tools to assess their risk.
In fact, more than 80% would like to be screened for oral cancer at every dental checkup. More significantly, 85% would be in favor of simple rinse and spit screenings like Vigilant’s and would be willing to pay $25 or more for them. However, less than 24% recall talking to their dentist about oral cancer risks at their last checkup.
“We want to continue to leverage the efforts of the ADA and the Oral Cancer Foundation and the CDC in promoting awareness of oral cancer and the behaviors that put people at risk,” Kim said. “I think the challenge is to educate the marketplace on where our product can truly address the current unmet need of early intervention.”
Once that education is accomplished, Kim is bullish about the future of the company and the future of people who may develop the disease.
“It’s been incredibly exciting to know that this technology is finally going to be in the hands of clinicians and benefit so many patients’ lives so that people will have better outcomes with oral cancer and will not have to endure as aggressive a treatment as my mother had to go through,” he said. “I just can’t be more excited about where we are today and where we are headed and beyond.”