Zila Europe, a division of Zila, Inc. (Nasdaq: ZILA), international provider of healthcare and biotechnology products and services for dental/medical professionals and consumers, announced that the British Ministry of Defense (MoD) will conduct a mouth cancer screening trial using Zila Europe�s OraTest oral cancer detection product. Of the Ministry�s roughly 200,000 personnel, 8-10,000 at-risk individuals (age 45 and older, smokers or drinkers) are expected to be examined with the OraTest product; some portion of those will be referred for biopsy and possible surgery. The trial will be officially launched during the first annual U.K. Mouth Cancer Awareness Week, which begins November 11, 2001.
MoD consultant head and neck specialist, Surgeon Commander D. K. Riden, RN FDSRCS, FRCS, FRCS (OMFS), who is based at the Royal Hospital Haslar, said the objectives of the trial are to gauge the efficacy of the OraTest product in the hands of the MoD�s general dental practitioners, and ensure that proper and efficient referral pathways are in place so that all personnel can be examined and treated in a timely fashion. "If the trial is successful, we would strongly recommend implementation of Ministry-wide annual OraTest screening for all at-risk personnel," Surg Cdr Riden said.
In the trial, the OraTest product, which is being donated by Zila Europe, will be used by MoD dentists at some 200 dental facilities at 19 military centres -- 14 in the U.K., four in Germany and one in Cyprus. MoD dentists are general practitioners, either employees of the armed services or civilian practitioners working under contract. All MoD dentists currently do full head, neck and soft tissue examinations, and every member of the armed forces is required to visit the dentist at least once a year. "Compliance with trial protocols will obviously not be an issue," Surg Cdr Riden noted.
At the present time, virtually all MoD personnel with suspicious oral lesions are referred to Royal Hospital Haslar for biopsy and possible surgery. For control purposes during the trial, all OraTest referral patients will be sent to Surg Cdr Riden.
Adrian Webber, vice president and general manager of Zila Europe, observed, "This will be the largest OraTest trial ever conducted, focusing on the utility of the product in the hands of the general practitioner. We are delighted with the decision of the MoD to undertake this trial."
The OraTest product is a patented five-minute mouthrinse sequence that has been shown to be 100 percent sensitive for squamous cell carcinoma (the most common type of mouth cancer). It is approved for use in the U.K. for screening, detection of second primary lesions, and defining margins of lesions for biopsy and surgery. The dentist administers the OraTest product by having patients rinse with a series of three solutions and water. This stains suspicious lesions deep blue, for evaluation by the clinician, and referral to a specialist as necessary.