Summary of OralCDx Clinical Studies

Complete List of Publications

The accuracy of OralCDx was demonstrated in one of the largest dental studies ever conducted and performed at 35 academic universities in the United States, involving nearly 1000 patients (Statistical sensitivity > 96%, p< .05; statistical specificity of OralCDx “positive” > 97% and “atypia” > 90%, p< .05). Based upon this study, which was published as the cover story in JADA, OralCDx received the American Dental Association’s prestigious Seal of Acceptance. 

In studies where brush biopsies and scalpel biopsies were performed concomitantly on the same lesion and by the same examiner, the high sensitivity and specificity of OralCDx, as determined in the US pivotal trial was replicated.  An independent study performed in Europe validated the high accuracy of the computer-assisted oral brush biopsy. In the European study, scalpel biopsy results were compared with brush biopsy results that were obtained from lesions sampled concomitantly by the same examiner.  The sensitivity for the brush biopsy was 92.3% (95% CI) and the specificity, 94.3% (95% CI).

The probability that a patient with an OralCDx “atypical” report has a precancerous or cancerous lesion, known as the positive predictive value, has been demonstrated in 5 independent clinical trials to be between 30%-44%. This is significantly higher than the positive predictive value for other cancer screening tests, such as the Pap smear and mammography.

The use of the oral brush biopsy as a highly accurate method of detecting precancers and cancers was incorporated into the 2006 National Cancer Institute’s Physician Data Query, better known as PDQ. (http://www.cancer.gov/cancertopics/pdq/screening/oral/healthprofessional/allpages).  PDQ is the National Cancer Institute’s comprehensive cancer database and contains peer-reviewed summaries on many aspects related to cancer including screening and prevention. The PDQ cancer information summaries are peer reviewed and updated regularly by specialists, who review current literature from more than 70 biomedical journals, evaluate its relevance, and synthesize it into clear summaries. Summaries on screening/detection for many of the common cancers, including oral cancer, are available and include supporting references to current literature. Given the rigorous review process of PDQ involving specialists from all fields of medicine, we attribute the recognition of the brush biopsy into the oral cancer PDQ to the strength of the clinical studies demonstrating the benefits and accuracy of OralCDx.