After working for more than 10 years on the problem, scientists from the University of Miami are getting ready to roll out a cheap, fast and easy test for detecting oral cancers early — even before anything visible appears.
Just as with other cancers, early detection is key to a better prognosis. But about 60 percent of oral cancers are caught in the later stages of the disease. And while a majority of non-smokers with HPV-related oral cancers will beat the disease with a combination of chemotherapy and radiation, for those who have tobacco-related late-stage cancers, the survival rate is only 30 percent.
Every year, about 43,000 new cases of oral cancer are diagnosed in the U.S., and approximately 640,000 worldwide.
According to Dr. Elizabeth Franzmann, a professor of otolaryngology at the University of Miami Miller School of Medicine and one of the test’s inventors, the reason too few oral cancer cases are caught early is because of the gap between what’s technically possible and what’s practically feasible.
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Right now, we can screen for oral cancer with careful exams, and we can biopsy whatever irregularities are found. And we know what makes someone most at risk for the disease: smoking, alcohol, and, increasingly, a certain strain of the human papillomavirus (HPV), the most common sexually transmitted infection in the United States.
But approximately 85 million people in the United States are smokers, heavy drinkers or HPV-positive, and therefore technically ‘at-risk’ for developing oral cancer. And 85 million people aren’t going to prioritize the time and money it takes to get those annual oral exams — not until they start exhibiting worrisome symptoms like painful lesions, and that’s often too late.
UM’s test is a way to triage between those who might need an oral exam, and those who definitely do.
“It’s very hard to carefully screen all of those people for a cancer which is horrible and fairly common with over 40,000 new cases in the U.S. each year, but rare when you think about the 85 million at risk,’’ Franzmann said. “So we need to think simpler than a skilled oral exam in order to help identify these people that are most at risk.”
So in concert with Vigilant Biosciences, a new medical technology company specialized in early intervention, Franzmann and other UM scientists have developed an oral cancer risk-assessment kit that’s cost effective and an easy-to-use “rinse and spit” test. They’re hoping to get FDA approval and to put the test in dental offices and public health screening facilities in 2015.
And while Franzmann is still not sure about the exact price points, she says the test will be cheap. Since her residency days, she has been doing head and neck surgery at Jackson Memorial Hospital, where most of the county’s uninsured go for emergency care. That’s largely what motivated this project.
“It was just really frustrating to have patients come in yet knowing that if we had found them earlier, we could have done a lot more for them,” she says. “It’s very important to me that it will eventually benefit those people, not just [people that can afford] something that’s hundreds of dollars.”
The kit comes with a testing strip, some saline solution and a collection cup. To use the kit, a patient will gargle the solution and spit into the cup. A health professional will then insert the test strip in the cup, and within just 10 minutes, a change in the strip’s color will indicate the patient’s current risk for oral cancer.
That color change is triggered by the proportional presence of one protein — CD44 — compared to the saliva’s total protein. It’s that proportion, Franzmann says, that roughly stratifies the chance that squamous cell carcinoma — which accounts for about 95 percent of all oral cancers — is developing somewhere in the oral cavity.
According to Franzmann, there’s even some evidence — at this point anecdotal — that the test can pick out even pre-cancer very early. “We have a few cases in our research where we thought that controls — subjects with no cancer — had elevated levels or abnormal marker levels and then went on over the course of months, to maybe a couple of years, to develop cancers in the mouth or throat.”
That’s “quite exciting,” she says, “because it may alert us to those patients who are at risk for developing cancer at a point in time when you can still reverse the process by getting them to stop risky behavior and taking better care of their health.”