A new, noninvasive cytology test for oral cancer, ClearPrep OC, is being offered free to dentists. The test, aimed at "watch and wait" lesions, is less expensive than biopsies and less frightening for patients, according to Resolution Biomedical, the company that is commercializing it.
The chairside oral cancer test -- which can be ordered directly from the company -- is designed to be a diagnostic option for assessing lesions when a biopsy is not warranted or the patient fears getting a biopsy, according to Donald Williams, MD, chief medical officer of Resolution Biomedical.
Biomedical
The test involves a cyto-brush sampling method that measures gross changes in the nuclear DNA content of oral epithelial cells, providing information about the precancerous or cancerous state of a lesion, the company explained. The samples are sent to medical testing labs, and the report is sent to the dentist within four to five days, the same time frame as biopsies. Dentists send the samples to the company, which prepares the slides and sends them to labs, which prepare a diagnostic report for the dentists.
"It's a way to triage patients where something may be suspicious but the patient is balking about getting a biopsy," Dr. Williams told DrBicuspid.com. "It could be leukoplakia lesions or thrush instead of an indication of a neoplasm. It rules out biopsies without an invasive process."
When dentists refer patients to periodontists to get biopsies of suspicious lesions, many patients don't follow through on the recommendation because they find it a daunting procedure, Dr. Williams noted.
"Some patients think, 'I've had this for years and it hasn't killed me, so I don't want to be biopsied,' " he said. "It's kind of frightening to say you're going to have a piece of meat cut out of your mouth."
The most logical application is for worrisome lesions that are likely benign, Dr. Williams said.
Ongoing clinical trial
Resolution Biomedical conducted about five validation studies of the ClearPrep OC test in general practices over six months, Dr. Williams said. It is now being tested with Southern California dentists.
In addition, the test is in the second phase of a trial study with cancer patients in the City of Hope cancer research hospital in Duarte, CA. ClearPrep OC and saliva samples will be taken, and p16 stains will be done on the biopsy specimens. All the modalities then will be combined before a blind match is done. The company plans to do a joint publication based on the results with the University of California, Los Angeles, Dr. Williams said.
The test was primarily designed for gynecologic cytology pap tests, but Resolution Biomedical realized it also had potential to detect oral cancer.
The company does not plan on doing an official launch of the product, which has no marketing restrictions since nongynecologic cytology tests are an established medical practice, according to Dr. Williams. As a result, the test does not require U.S. Food and Drug Administration clearance or need to be Clinical Laboratory Improvement Amendments (CLIA)-certified, he said.
While the test is being provided for free to dentists, patients and labs pay $60 to $125 -- much less than biopsies, which range from $400 to $500, according to Dr. Williams. It is usually covered by insurance, and dentists can charge a collection fee for the process, including interpreting the final report, according to Dr. Williams. Company revenues will be derived from the testing labs it uses for analysis.
"Biopsies are invasive, expensive, and painful," said company CEO Mike Friedl. "This is an intermediate way to rule out stuff while you're still at the dentist rather than going to a specialist."
The test is especially suitable if the condition is simply a treatable condition, such as a fungal change, and doesn't require a trip to see a specialist, Friedl noted. Since the human papillomavirus (HPV) is now associated with many oral cancers, the company tests for it if the sample shows any degree of atypism.
Sol Silverman Jr., DDS, a professor of oral medicine in the University of California, San Francisco (UCSF) School of Dentistry and head of one of the oral medicine clinics at UCSF, called the ClearPrep test a good adjunctive diagnostic technique.
"Cytology has been around a long time, and it's very high-quality," Dr. Silverman told DrBicuspid.com. "Any technique that will accelerate the recognition of dysplasia is important. Early detection is still our best approach to good survival results."
