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Educational Presentation Educational Presentation to the ECCC to the ECCC OralCDx Brush Biopsy Brush Biopsy - - OralCDx Technique and Indications Technique and Indications Mark Rutenberg CEO & Founder, CDx Laboratories March 6, 2008

Whatever happened to cervical cancer? Whatever happened to cervical cancer? In 1950, cervical cancer was the leading cause of cancer death in American women. Between 1955 and 1992, cervical cancer incidence fell from 1 st to 14 th place.

Cervical cancer was conquered because we found a way to tell which women had cervical dysplasia – years before cervical cancer could even start. Dysplasia Cancer Years Later Years Later Basement Membrane As in the cervix, if oral dysplasia is found and removed before the basement membrane is penetrated, then oral cancer can never get started.

The Dentist’ ’s Dilemma s Dilemma The Dentist � The Problem The Problem � � About 10% of adult patients have small oral spots About 10% of adult patients have small oral spots � � > 96% if these spots do not contain abnormal cells > 96% if these spots do not contain abnormal cells � � Only laboratory testing can determine that a spot is Only laboratory testing can determine that a spot is � not dysplastic. not dysplastic. � Can Can’ ’t subject 10% of all patients to a scalpel biopsy t subject 10% of all patients to a scalpel biopsy � to find the small number of them that have a to find the small number of them that have a dysplastic spot. dysplastic spot.

The Dentist’ ’s Dilemma s Dilemma The Dentist � The Result The Result � � Harmless appearing precancerous oral spots are Harmless appearing precancerous oral spots are � often allowed to progress until they look often allowed to progress until they look “suspicious suspicious” ” “ � By that time they are typically oral cancers. By that time they are typically oral cancers. �

OralCDx BrushTest™ ™ OralCDx BrushTest The Solution to the Dentist he Solution to the Dentist’ ’s Dilemma s Dilemma T � A routine test of the small, harmless A routine test of the small, harmless- -appearing, white appearing, white � and red tissue spots that appear in about 10% of your and red tissue spots that appear in about 10% of your patients patients � Used to determine which 4% of these common spots Used to determine which 4% of these common spots � contain unhealthy cells (dysplasia). contain unhealthy cells (dysplasia). � OralCDx detects dysplasia long before it can penetrate OralCDx detects dysplasia long before it can penetrate � the basement membrane and cause any harm – – years years the basement membrane and cause any harm before it can develop into an oral cancer before it can develop into an oral cancer

OralCDx BrushTest™ ™ OralCDx BrushTest The Solution to the Dentist he Solution to the Dentist’ ’s Dilemma s Dilemma T � OralCDx is not intended to test OralCDx is not intended to test “ “suspicious suspicious” ” oral oral � lesions. These should continue to be sent to the lesions. These should continue to be sent to the oral surgeon for a scalpel biopsy. oral surgeon for a scalpel biopsy. � OralCDx is intended to test OralCDx is intended to test “ “everyday everyday” ” oral spots oral spots � to detect the 4% of them which may contain still to detect the 4% of them which may contain still harmless dysplasia - - years before a suspicious years before a suspicious harmless dysplasia lesion can form. lesion can form.

Brush Biopsy Indications Brush Biopsy Indications � White or red spots, chronic ulcerations, mucosal White or red spots, chronic ulcerations, mucosal � lesions with an abnormal epithelial surface lesions with an abnormal epithelial surface � Common, small, benign Common, small, benign- - looking abnormalities looking abnormalities � that have been routinely “ “watched watched” ” and not and not that have been routinely suspicious enough to warrant referral for biopsy suspicious enough to warrant referral for biopsy

Brush Biopsy Contraindications Brush Biopsy Contraindications � Lesions with intact normal epithelium Lesions with intact normal epithelium � � fibromas, mucoceles, hemangiomas, submucosal fibromas, mucoceles, hemangiomas, submucosal � masses, pigmented lesions masses, pigmented lesions � highly suspicious lesions (immediate scalpel biopsy) highly suspicious lesions (immediate scalpel biopsy) � � lesions with obvious etiology: herpes, aphthous lesions with obvious etiology: herpes, aphthous � ulcerations, trauma ulcerations, trauma

What to Expect in What to Expect in Your Practice Your Practice Harmless appearing, Known benign Highly suspicious white or red spots of entities lesions unknown origin fibromas, mucoceles, linea alba, Fordyce granules, aphthous Presentation ulcers, traumatic ulcers, herpes labialis, amalgam tattoos Frequency in Several Once or twice average practice Several times a week times each each year day Observe or BrushTest Scalpel Action treat biopsy

Proper Patient Communication is Key Proper Patient Communication is Key “Small oral spots are very common. We see Small oral spots are very common. We see “ them in about 10% of our patients” ”. . them in about 10% of our patients “We BrushTest common oral spots because We BrushTest common oral spots because “ they sometimes contain unhealthy cells that they sometimes contain unhealthy cells that may eventually become oral cancer if left may eventually become oral cancer if left untreated” ”. . untreated “Even if a spot is found by the BrushTest to Even if a spot is found by the BrushTest to “ contain unhealthy cells that is nothing to worry that is nothing to worry contain unhealthy cells about as it is typically still harmless. It can then as it is typically still harmless. It can then about be easily removed and we will have prevented be easily removed and we will have prevented a problem - - years before it can even start years before it can even start ” ”. . a problem

OralCDx Testing OralCDx Testing Two Components Two Components � Office Office Procedure Procedure- - OralCDx OralCDx � BrushTest BrushTest � Laboratory Analysis Laboratory Analysis - - Computer Computer- - � assisted inspection specifically assisted inspection specifically designed for oral dysplasia. designed for oral dysplasia.

The OralCDx Test Kit The OralCDx Test Kit Components of kits: Components of kits: � oral BrushTest instrument oral BrushTest instrument � � precoded glass slide and precoded glass slide and � matching coded test matching coded test requisition form requisition form � alcohol/carbowax fixative alcohol/carbowax fixative � pouch pouch � container for submitting the container for submitting the � contents contents

OralCDx BrushTest OralCDx BrushTest � Brush is sterile Brush is sterile � � Two cutting surfaces Two cutting surfaces � � Cytology instruments collect only Cytology instruments collect only � superficial cells. Brush biopsy superficial cells. Brush biopsy collects cells from all three collects cells from all three epithelial layers: superficial, epithelial layers: superficial, intermediate and basal intermediate and basal

Exfoliative Oral Cytology Exfoliative Oral Cytology � Banoczy; Banoczy; Int Dent J Int Dent J : 1976 : 1976 � False negative rate for leukoplakia: 69% � False negative rate for leukoplakia: 69% � � Folsom et al. 1972 Folsom et al. 1972 Oral Surgery Oral Surgery � False negative rate for oral cancer: 31% � False negative rate for oral cancer: 31% � Cytology is not an acceptable or reliable Cytology is not an acceptable or reliable method of evaluating oral lesions for method of evaluating oral lesions for precancer and cancer precancer and cancer

Guidelines for Anesthesia Guidelines for Anesthesia � Causes minimal or no bleeding or pain Causes minimal or no bleeding or pain � � Topical or local anesthesia is generally not Topical or local anesthesia is generally not � required required � For highly inflamed or ulcerated lesions, local or For highly inflamed or ulcerated lesions, local or � topical anesthesia may be used topical anesthesia may be used � Topical anesthesia Topical anesthesia � � gels, sprays and creams OK gels, sprays and creams OK � � ointments should not be used ointments should not be used �

Brush Biopsy Technique Brush Biopsy Technique Review Review � The flat surface should be used in most cases. The flat surface should be used in most cases. � � Apply firm pressure against the lesion Apply firm pressure against the lesion - - you you � should see a slight bend in the brush should see a slight bend in the brush � Rotate clockwise 10 times or more Rotate clockwise 10 times or more � � Pink tissue or microbleeding indicates that the Pink tissue or microbleeding indicates that the � brush has penetrated to the basement brush has penetrated to the basement membrane membrane � If lesion bleeds, stop brushing and transfer material If lesion bleeds, stop brushing and transfer material � to slide to slide