LED Medical Diagnostics Inc. (“LED” or the “Company”) (TSX-VEN: LMD) is pleased to announce the results of a meta-analysis of the clinical use of autofluorescence to evaluate its accuracy in the diagnosis of oral squamous cell carcinoma (OSCC) and oral potentially malignant diseases (OPMDs) and to explore its applicability in general dental practice.
The study by Luo et al.1, entitled “Accuracy of Autofluorescence in the Diagnosis of Oral Squamous Cell Carcinoma and Oral Potentially Malignant Diseases: A Comparative Study with Aerodigestive Lesions,” has been published in Scientific Reports, an online open access journal published by the publisher of Nature, a leading international scientific weekly.
This study is a meta-analysis of previously published data to evaluate the accuracy of autofluorescence in diagnosing oral squamous cell carcinoma (OSCC) and oral subepithelial nodular disease (OPMD) and reports the results of a statistical analysis of 24 previously reported studies that examined a total of 2761 OSCC and OPMD lesions.
The study reported that the pooled sensitivity and specificity of autofluorescence for detecting OSCC and OPMD were 0.89 and 0.80, respectively, and concluded that autofluorescence is a promising noninvasive tool for the early diagnosis of OSCC and OPMD. The authors of the study also noted that autofluorescence may be most reliable in the hands of oral specialists as an adjunctive imaging tool, but the use of promising clinical decision algorithms could facilitate its use in primary care.
LED CEO Dr. David Gane commented, “The results of this study will be of great interest to patients and physicians. The results further validate the use of autofluorescence-based imaging tools, such as the VELscope, in the management of oral tissue abnormalities, including oral cancer. This report further confirms the effectiveness of the VELscope as an effective adjunct to screening for oral cancer and precancerous lesions. As acknowledged in the study, there is a critical need for frontline dental practitioners to have additional diagnostic aids to enable early detection of oral squamous cell carcinoma and dysplasia.”
“We wholeheartedly support the authors’ conclusions regarding the importance of using autofluorescence in general practitioners’ clinical decision-making algorithms and have advocated for this for many years,” said Dr. David Morgan, Chief Technology Officer of LED Dental Inc., a wholly owned subsidiary of LED.
It is also important to note that while this study provides a very thorough analysis of the peer-reviewed literature related to early diagnosis, the VELscope Vx is not approved as a stand-alone diagnostic device, but rather as an adjunct to enhance visualization of oral abnormalities.”
With more than 40,000 new cases of oral cancer each year in the U.S. alone, early detection is critical to survival; with early detection of oral cancer, the five-year survival rate can increase from less than 50% to more than 80%. The VELscope system is used more than any other adjunct to the examination of oral cancer and other oral diseases.
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