OralCDx Brush Biopsy

Computer-Assisted Transepithelial Oral Brush Biopsy


OralCDx Transepithelial Oral Biopsy Brush

The OralCDx Brush Biopsy (or BrushTest® as it's marketed in the dental market) is an in-office test to help ensure that the harmless-appearing white or red spots in your patient’s mouths are not precancerous or cancerous. OralCDx consists of 2 components: 1) a specially designed brush that is used to painlessly obtain a sample of an oral lesion. In contrast to a typical cytologic smear, like a Pap smear, which samples cells only from the superficial layer, the OralCDx brush obtains a complete transepithelial biopsy specimen collecting cells from all three layers of the epithelium: the superficial, intermediate and the basal layer. OralCDx requires no anesthesia, causes no pain and minimal or no bleeding. 2) the analysis of the OralCDx sample is aided with highly sophisticated computers at a specialty laboratory where specially-trained pathologists render a result.

OralCDx is very accurate and has been the subject of well controlled, randomized, clinical trials. In every study in which the same lesion was simultaneously tested with both an OralCDx brush and scalpel biopsy, OralCDx was shown to be at least as sensitive to a scalpel biopsy in identifying dysplasia or cancer. In addition, the positive and negative predictive values of OralCDx have been repeatedly shown in published studies to be substantially greater than other accepted life-saving tests such as the Pap smear, mammogram, and PSA.



"In every study in which the same lesion was simultaneously tested with both a brush and scalpel biopsy, OralCDx was shown to have a sensitivity and specificity well over 90%."

- Mehrotra R, MD



Transepithelial Brush Biopsy Overview


OralCDx Brush Biopsy Technique

Sample Image

The oral biopsy brush is firmly pressed against lesion and rotated until pinpoint bleeding is observed.

The brush is then rotated onto the enclosed glass slide, transferring the cellular material.

The sample is then preserved by immediately emptying the contents of a complete fixative packet onto slide.The sample is allowed to dry for 15 minutes. slide is then placed into

The dry slide in then placed into the supplied slide holder, placed back into the box, and shipped to the lab for analysis.

Harmless-appearing common oral spots
These are examples of harmless-appearing tissue changes that need to be tested to determine if any dysplastic cells are present.

Full Transepithelial Sample

Comparison of cells collected by standard biopsy with brush biopsy

A specimen smear is prepared from the sample and analyzed at the CDx laboratory with the aid of a proprietary high speed computer system which assists a specially trained pathologist in locating potentially abnormal cells and cell clusters.

Benefits of the OralCDx Brush Biopsy

Sample Image

The OralCDx BrushTest is a highly accurate, noninvasive chair-side biopsy that can be used to rule out the possibility that an oral lesion is dysplastic or cancerous.

  • Requires no topical or local anesthesia
  • Chair-side procedure that is easy to perform
  • Samples a larger area than scalpel biopsy
  • Achieves a complete transepithelial biopsy tissue specimen with cells sampled from all layers of the epithelium
  • Highly accurate and at least as sensitive as a scalpel biopsy in ruling out oral dysplasia and carcinoma


"It's a diagnostic tool to be used as an adjunct to the oral examination because it definitively determines the significance of an oral abnormality.

OralCDx confirms the benign nature of those lesions that clinically appear to be benign, and more importantly identifies precancerous and cancerous lesions; differentiating them from common-looking benign lesions."

James Scuibba, D.M.D., Ph.D, Director of Dental and Oral Medicine at Johns Hopkins Medical Center

 

Oral Cancer Overview

Oral cancer kills nearly as many Americans every year as malignant melanoma and almost twice as many as cervical cancer. Only about half of oral cancer patients survive more than 5 years, and the poor mortality rate has remained unchanged for 50 years. With early detection, the survival rate for oral cancer is well over 80%, compared with late stage detection when the survival rate drops to a dismal 19%. When dysplasia is identified and treated, oral cancer cab potentially be prevented from even starting.


Oral Cancer: What Causes It?

Although tobacco and alcohol have long been implicated as traditional risk factors for oral cancer in adults of any age, a significant number of young patients, under age 40, with oral cancer have never smoked or consumed alcohol. In the past 30 years, there has been an alarming five fold increase in incidence in oral cancer patients under age 40. The incidence of oral cancer in women is increasing significantly, and females now account for about one third of all oral cancer cases. Identifying and treating epithelial dysplasias before they become cancer has proven to be one of the most effective methods for reducing the incidence and mortality of other types of cancers. The widespread use of the Pap smear offers a striking example of how a simple diagnostic test impacted the incidence and survival rate of cervical cancer. In 1955, cervical cancer was one of the leading causes of death among American women. As the Pap smear became adopted into routine practice as a method of detecting dysplasia, the number of cervical cancer deaths dropped considerably and the disease went from the 2nd to the 11th leading cause of death.


Is it Hard to Detect Oral Cancer?

A number of obstacles hinder detection of dysplasia and early oral cancers. Biopsy of an oral lesion is an invasive procedure associated with potential morbidity and is almost always performed by a specialist. Consequently, oral lesions are typically biopsied when they display suspicious clinical signs and symptoms of disease.

Early- stage oral cancers and dyplasias often do not exhibit suspicious clinical features that are visually recognizable and moreover, they resemble harmless-appearing oral lesions. They are often small or even tiny and appear as a flat, white or red areas. Such lesions do not cause pain or bleeding and most patients are not even aware of their presence. Despite the ease of examining the oral cavity for abnormalities, clinically differentiating premalignant and malignant lesions from similarly appearing benign lesions is not often possible without biopsy.

Another obstacle to the identification of precancers and early cancers is the fact that a large segment of the population develops oral lesions making it impractical to biopsy every one of them. Studies have repeatedly demonstrated that up to15% of all patients have an oral lesion. Although the great majority of these lesions are harmless, identifying those that are dysplastic and cancerous is vital.


Evaluating Spots To Help Prevent Oral Cancer

There is no longer any reason to guess or take a chance. Use the OralCDx BrushTest® to routinely evaluate common oral white and red lesions Since it typically takes several years before dysplasia develops into oral cancer, precancerous spots identified by OralCDx® can be removed potentially preventing oral cancer from even starting.