Quality Resource Guide l Techniques for Early Cancer Detection 3rd Edition 3 www.metdental.com TB is not cleared by the FDA as a stand-alone adjunct. It is cleared for marketing as a follow-on case assessment marking agent for the light- based adjunct ViziLite ® TBlue Annual Oral Cancer Screening System. 42 The premise is the TB allows for better visual lesion delineation of an area initially identified by the ViziLite ® . 42 It may also help the provider decide which area within a lesion should be biopsied. The appropriate CDT code to apply when using TB is D0431, “adjunctive pre-diagnostic test that aids in the detection of mucosal abnormalities including premalignant and malignant lesions, not to include cytology or biopsy procedures.” 14 Light-based Adjuncts Light-based adjuncts can be categorized into two basic groups (tissue reflectance and autofluorescence) based on the manner in which a specific spectrum of light is used to assess the reflective properties of the tissue. All are cleared for marketing by the FDA as chairside illumination aids to assist the practitioner in identifying new or potentially overlooked OPMDs. 2,43 Some are also marketed to assist the surgeon in defining the appropriate surgical margins for excision. 38,44 The appropriate CDT code to apply when using a light-based adjunct is D0431, “adjunctive pre-diagnostic test that aids in the detection of mucosal abnormalities including premalignant and malignant lesions, not to include cytology or biopsy procedures.” 14 The tissue reflectance adjunct (ViziLite ® TBlue Annual Oral Cancer Screening System) utilizes a blue-white light (wavelength of 430 and 580 nm) to analyze the tissues. 45 The light is generated through a reaction between acetylsalicylic acid and hydrogen peroxide (chemiluminescence). The protocol entails the use of a 60 second pre-rinse with a 1% acetic acid solution to remove the surface glycoprotein layer and cause cellular dehydration, to improve the exposure of cellular elements to the blue-white light. 33,45 The premise is that healthy cells absorb the blue-white light while dysplastic cells reflect the blue-white back to the examiner as “aceto-white” brightness. 36,46 Autofluorescence adjuncts (VELscope ® , BioScreen ® , DOE SE Kit, OralID™, ViziLite PRO ® Oral Lesion Screening System, Goccles) use light spectra in the 390 – 460 nm range to assess the autofluorescent character of the mucosal tissues. 45 A narrow band filter (either in the device viewfinder or via eyewear) is used to highlight the autofluorescent character of the examined tissue. The working premise is that dysplastic or carcinogenic tissues are associated with an altered autofluorescence signature, due to increased collagen destruction, specific nuclear/ Table 4 - Available Biomarker-based Adjuncts 28-30 Product Company Biomarkers Assessed OraRisk ® HPV Complete Genotype OralDNALabs Eden Prairie, MN 51 HPV strains, to include low, high and unknown risk strains OralCDx ® CDx Diagnostics Suffren, NY Immunohistochemistry testing for CDX2, MUC2, AMACR, P16, P53, KI67, HSV, H.pylori CancerDetect ® Oral & Throat Viome Life Sciences, Inc. Bellevue, WA Metatranscriptome (RNA), microbiome Table 3 - Available Light-based Adjuncts 21-27 Adjunct Contact ViziLite ® TBlue Annual Oral Cancer Screening System* Den-Mat Holdings, LLC Lompoc, CA VELscope ® LED Dental, White Rock, British Columbia, Canada Bio/Screen ® AdDent, Inc., Danbury, CT DOE SE Kit DentLight Inc., Plano, TX Identafi ® DentalEZ, Malvern, PA OralID™ Forward Science, Houston, TX ViziLite PRO ® Oral Lesion Screening System Den-Mat Holdings, LLC Lompoc, CA Goccles Pierrel S.P.A., Capua, Italy Table 2 - Available Vital Stain-based Adjunct 21 Adjunct Contact Toluidine chloride stain (component of ViziLite ® TBlue Annual Oral Cancer Screening System) Den-Mat Holdings, LLC Lompoc, CA Table 1 - Available Cytology-based Adjuncts 20 Adjunct Contact OralCDx ® CDx Diagnostics, Suffren, NY