ViziLite Plus with TBlue630 is an oral lesion identification and marking system that is used as an adjunct to the conventional head and neck examination. It is comprised of a chemiluminescent light source (ViziLite) to improve the identification of lesions and a blue phenothiazine dye to mark those lesions identified by ViziLite. ViziLitePlus with TBlue630 is designed to be used in a patient population at increased risk for oral cancer.
In clinical trials involving 13,000 female patients, abnormal squamous epithelium in the cervical complex appears acetowhite after rinsing with a dilute acetic acid solution and viewed under chemiluminescent light (Speculite®). Similarly in the oral cavity, after rinsing with a dilute acetic acid solution, abnormal squamous epithelium tissue will appear acetowhite when viewed under ViziLite's diffuse low-energy wavelength light. Normal epithelium will absorb the light and appear dark. ViziLite can assist a dentist or hygienist in identifying an abnormality in the oral cavity.
TBlue630 is a patented, pharmaceutical-grade toluidine blue-based metachromatic dye. It is used to further evaluate and closely monitor changes in ViziLite-identified lesions. It has been proposed that living cells will differentially accumulate toluidine blue based on parameters related to metabolic activity. TBlue630, packaged in an easy to use 3-swab system, provides the deep blue staining that allows ViziLite-identified lesions to be seen clearly under normal light.