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LED Medical Diagnostics Inc.: Recent Study Concludes Quantitative Cytology Effective for Identifying High-Risk Epithelial Oral Lesions

Apr 24 2013 12:00AM

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BURNABY, BRITISH COLUMBIA -- (Marketwired) -- 04/24/13 -- LED Medical Diagnostics Inc. (TSX VENTURE: LMD)(OTCQX: LEDIF)(FRANKFURT: LME) ("LED Medical"), a strategic partner in Second Step Laboratory Services with PMI is pleased to announce the results of an independent study published in "Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology" (Vol. 114 No. 3) that confirms the use of quantitative cytology ("QC") testing, as an adjunctive tool, successfully identifying high-risk potentially malignant disorders of the oral mucosa.

The study, entitled "The Use of Quantitative Cytology in Identifying High-Risk Oral Lesions in Community Practice" by Samson P. Ng, DMD, MSc, Indervir S. Mann, DDS, Christopher Zed, DDS, MBA, Alexei Doudkine, PhD, and Jasenka Matisic, MD (September 2012 - visit http://www.ncbi.nlm.nih.gov/pubmed/22862977 for the abstract), was conducted utilizing 171 patients at a community-based clinic in British Columbia. All subjects had suspicious oral lesions and were evaluated with concurrent but independent histopathologic and quantitative assessments.

The results of the study showed that "QC-positive results were associated with oral lesions with higher clinical risk factors: large size, nonhomogeneous surface texture, and located at high-risk anatomic sites. Only 3% of benign/reactive and 5% of low-risk PMDs were QC positive, while 92% of high-risk PMDs and 88% of squamous cell carcinomas (SCCs) were QC positive. The sensitivity and specificity of QC for detection of high-grade dysplasia/SCC were 89% and 97%."

The study supports the value of using QC as an adjunctive, case-identification tool, as it "showed high sensitivity and specificity to identifying high-risk epithelial oral lesions that require immediate care in a community setting."

"QC also has some obvious advantages over conventional invasive diagnostic procedures such as a conventional tissue biopsy," states Peter Whitehead, CEO and President of LED Dental Inc., a wholly-owned subsidiary of LED Medical Diagnostics Inc. "QC sample acquisition is non-aggressive, quick, relatively painless and less traumatic for the patient. As an adjunctive tool, it can provide the information a dentist requires about the possible cancerous or dysplastic nature of a lesion and the results can then expedite the clinical decision-making process - possibly leading to a less radical treatment and an improved outcome."

About Second Step Laboratory Services

Second Step Laboratory Services ("Second Step") was formed as a partnership between LED Dental Inc., maker of the VELscope® Vx Enhanced Oral Assessment System, and PMI Labs, a fully accredited anatomical pathology laboratory, to serve an important role in the Canadian dental community's commitment to reduce oral cancer mortality and morbidity statistics.

Second Step has streamlined a full range of oral pathology services, specifically for dental practices. Its oral cytology reports provide clinicians with fast, reliable information that helps them expedite patients along appropriate clinical pathways.

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