Clinical Studies

+OralCDx Brush Biopsy: Oral Dysplasia and Carcinoma

Improving Detection of Precancerous and Cancerous Oral Lesions: Computer-Assisted Analysis of the Oral Brush Biopsy

JADA, Vol. 130, October 1999 1445-1457.
James J. Sciubba, DMD, Ph. D., Johns Hopkins University, for the U.S. Collaborative OralCDx Study Group

Background: A study group composed of researchers from across the United States undertook a study to evaluate the sensitivity and specificity of OralCDx (OralScan Laboratories Inc.), a computer-assisted method of analysis of the oral brush biopsy, in the detection of precancerous and cancerous lesions of the oral mucosa.

Methods: The study group conducted a multicenter double-blind study comparing results of OralCDx analysis with those of scalpel biopsy of suspicious oral lesions, as well as using OralCDx on oral lesions that appeared benign clinically.

Results: In 945 patients, OralCDx independently detected every case of histologically confirmed oral dysplasia and carcinoma (sensitivity= 100 percent, false-negative rate = 0 percent).Every OralCDx “positive” result was subsequently confirmed by histology as dysplasia or carcinoma. The specificity for the OralCDx “positive” result was 100 percent, while the specificity for the OralCDx “atypical” result was 92.9 percent. In 4.5 percent of clinically benign-appearing lesions that would not have received additional testing or attention other than clinical follow-up, OralCDx uncovered dysplasia or carcinoma (statistical sensitivity > 96 percent, P < .05, n = 131; statistical specificity for the OralCDx “positive” result > 97 percent and for the “atypical” result > 90 percent, P < .05, n = 196).

Conclusions: The authors propose that this multicenter trial demonstrates that OralCDx is a highly accurate method of detecting oral precancerous and cancerous lesions. OralCDx can aid in confirming the nature of apparently benign oral lesions and, more significantly, revealing those that are precancerous and cancerous when they are not clinically suspected of being so. All OralCDx “atypical” and “positive” results should be referred for scalpel biopsy and histology to completely characterize the lesion.

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+CDx Laryngeal-Pharyngeal Dysplasia and Carcinoma

Office-Based Laryngeal Procedures

Otolaryngol Clin N Am, 39 (2006) 111-133
Peak Woo, MD, FACS, Department of Otolaryngology, Mount Sinai School of Medicine, The Grabscheid Voice Center

Abstract: In a series of 24 patients, the author performed both brush biopsy and standard biopsies of the larynx in unsedated patients under local anesthesia with either flexible or rigid instrumentation. There were no complications such as hemoptysis, pneumonia or laryngospasm. All the samples were adequate in sampling of the basal layer of the epithelium. As there were no failures from the fiberoptic or the rigid brush techniques, the two different techniques done to perform the brush biopsy were equal in terms of sampling adequacy.

The positive predictive value of a ‘positive’ or ‘atypical’ brush biopsy for neoplasia or dysplasia was 84.2% in this series. The positive predictive value of a negative brush biopsy for benign conditions of the larynx was 87.5%.

It should be noted that brush biopsy is different than brush cytology in the larynx. Prior experience in using office brush cytology in the larynx was not successful due to: a) the failure to get adequate depth of tissue sampling of the basal layer, and b) inadequate sampling by the surgeon or cytologist in preparation and interpretation of the cytological sample. The EndoCDx brush biopsy system is different in that the brush has a sharp edge designed to sample the basal layer and the brush biopsy specimen is analyzed with the aid of a computer to assess all the cells collected.

The EndoCDx brush biopsy was easier to perform than a standard cup force biopsy of the larynx.

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