Fight Against Oral Cancer
New, Painless Test Gives Dentists a Tool in the Fight Against Oral Cancer

SUFFERN, NY -- (March 27, 2001) – Now available in dental offices around the country is a new system that allows dentists, for the first time, to easily and painlessly test for oral cancer, a potentially deadly disease that affects more than 30,000 Americans each year, claiming 9,000 lives.

The novel testing tool is called OralCDx, a system that combines a painless brush biopsy, which is taken by the dentist in the office, and advanced computer analysis. OralCDx allows dentists to test for early signs of oral cancer, which may have previously gone undiagnosed.

OralCDx addresses a significant diagnostic dilemma for dentists. In the early stages, oral cancer can be difficult to detect. It presents as small red and white sores or lesions in the mouth, which are, on visual inspection, virtually indistinguishable from benign lumps or bumps that can form in the mouth. Dentists could only observe these lesions over time, many of which are likely to be benign, or refer the patient to an oral surgeon to have them removed surgically for testing in a procedure called a scalpel biopsy.

According to published studies, between five and 15 percent or adults have a benign-appearing white or red sore in their mouths that could be pre-cancerous. People who are tobacco users and those who consume large amounts of alcohol are at greater risk for developing oral cancer. However, more than 25% of oral cancer cases occur in people who have no known risk factors.

“The mortality rate for oral cancer has not improved in the last 40 years with 50 percent of those diagnosed dying within five years,” said James Sciubba, D.M.D., Ph.D., Director of the Division of Dental and Oral Medicine at Johns Hopkins Medical Center. “These statisitics have not changed primarily because individuals with oral cancer arrive in dentists’ or physicians’ offices in an advanced stage when survival is seriously compromised.”

Here is how OralCDx works: Using a special, hand-held brush, dentists take a small sample of tissue from the suspicious lesion. The sample is put on a slide and sent to OralScan Laboratory, based in Suffern, New York. At the lab, computers use advanced robotics, scanning and imaging techniques – technology originally developed for the defense industry –to accurately examine the thousands of cells on the sample. The computer is able to look at every cell, compare them to libraries of normal and abnormal cells and determine which cells are potentially problematic. A summary report is returned to the dentist for his/her files or for further discussion with the patient. If the OralCDx test is positive or atypical, the dentist will then confirm it with a standard incisional biopsy. And even if the OralCDx test turns out to be negative, but if the lesion persists, it should receive a follow-up evaluation.

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OralCDx has been evaluated in a multicenter clinical trial that involved 35 U.S. academic dental sites. The findings were published in the Journal of the American Dental Association (JADA) in October 1999.

“It's a wonderful feeling knowing that I am doing all I can for my patients," said Kim Knoll, M.D. a practicing dentist in the Washington DC area. "More importantly, OralCDx gives me a comfort level to know that every lesion can be adequately tested for oral cancer.”

The new test has also been reviewed by the Council on Scientific Affairs of the American Dental Association and has received the organization’s prestigious Seal of Acceptance.

OralCDx was developed by OralScan Laboratories, a medical technology and biotechnology company dedicated to the detection of cancer at its earliest most curable stage through its specialty laboratory testing of lesions observed in the oral cavity, nasopharanyx, hypopharynx, pharynx, trachea, larynx and esophagus. OralCDx is exclusively distributed by Sullivan-Schein Dental, a subsidiary of Henry Schein, Inc. (Nasdaq: HSIC).

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Last Updated October 2004