Researchers from the U.S. have developed a simple saliva test that may improve oral cancer diagnostics significantly. Once the device has been approved by the FDA, they hope that the low-cost product will form part of annual routine dental exams and benefit patients with limited access to health care in particular.
The test was developed by researchers at the University of Miami Miller School of Medicine in collaboration with Vigilant Biosciences, a Miami-based medical technology company. It consists of an oral cancer-specific oral rinse test strip that immediately changes color in the presence of certain levels of proteins clinically proven to be associated with early onset of the disease.
"There is a tremendous need for a simple and painless test for early oral cancer because the majority of patients present at a late stage when cure rates reach only 40 percent," said Dr. Elizabeth J. Franzmann, associate professor of otolaryngology at the school.
In the largest oral cancer marker study of its kind, Franzmann and her team conducted preliminary tests of the strip among 300 cancer patients and healthy controls. The patients rinsed their mouth with 5 cc (a teaspoon) of saline, swishing for five seconds and gargling for five seconds, and then spat into a collection tube. The saliva solution was then analyzed for the presence of at least two markers of early-stage squamous cell carcinoma, which is often linked to tobacco and alcohol use and the human papillomavirus.
Matthew H.J. Kim, founder and chairman of Vigilant Biosciences, is currently working on bringing the rinse and spit test to dental offices, primary care practices and drug stores. In 2010, he signed a licensing agreement with the university that gives the startup exclusive rights to Franzmann's patented technology. However, the test is still two or three years away from being commercially available, the company announced.
According to the researchers, about 42,000 new cases in the U.S. and 640,000 people worldwide are diagnosed with oral cancer each year, with more than half of those patients dying within five years of diagnosis owing to late-stage diagnosis and intervention.
The findings were presented at the annual meeting of the American Association for Cancer Research in Washington, D.C., and the annual meeting of the American Head and Neck Society in Orlando, Fla.
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