Recent Study Concludes Quantitative Cytology Effective for Identifying High?Risk Epithelial Oral Lesions
Study Supports the pathology services of Second Step Laboratory Services, a strategic partnership between operating subsidiary LED Dental Inc. and PMI Labs.
BURNABY, British Columbia ? April 24, 2013 ? LED Medical Diagnostics Inc. (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 istopathologic 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.
When compared to surgical biopsy, acquiring a cytology specimen is minimally invasive, requiring only a brush sample of epithelial cells. The test helps differentiate benign oral lesions from potentially malignant ones. This ground?breaking test is based on measurement of large?scale DNA abnormalities from cytology preparations using Health Canada approved image cytometry technology. For more information, visit www.secondsteplabs.com.
About PMI Labs
PMI Labs is the laboratory services segment of Perceptronix Medical Inc. accredited with the Diagnostic Accreditation Program of BC Physicians and Surgeons. Founded in 1999, Perceptronix Medical Inc is an ISO 9001:2000 and ISO 13485:2003 certified company providing anatomic pathology services to medical and dental professionals in support of earlier diagnosis for better patient outcomes.
PMI Labs has developed a proprietary quantitative cytology technology to provide new, highly informative early cancer detection tests. The technology was developed in partnership with the British Columbia Cancer Agency (Cancer Research Center) in Vancouver, a renowned cancer research and treatment facility with a successful track record in implementing early cancer detection programs. For more information, visit www.pmilabs.com.
About LED Medical Diagnostics Inc.
Founded in 2003 and headquartered in Burnaby, British Columbia, Canada, LED Medical Diagnostics Inc. is a leading developer of LED?based visualization technologies for the medical industry. The Company is currently listed on the Toronto Stock Exchange (TSX?V) under the symbol LMD, the OTCQX under the symbol LEDIF, as well as the Frankfurt Stock Exchange under the symbol LME. For more information, visit www.ledmd.com.
Through its wholly?owned subsidiary, LED Dental Inc., the company manufactures the VELscope® Vx Enhanced Oral Assessment System, the first system in the world to apply tissue fluorescence visualization technology to the oral cavity. VELscope® Vx devices are now used to conduct more screenings for oral cancer and other oral tissue abnormalities than any other adjunctive device. For more information, visit www.leddental.com.
For media or investor relations inquiries, please contact:
Forward Looking Statement
This press release contains statements which, to the extent that they are not recitations of historical fact, may constitute forward-looking information under applicable Canadian securities legislation that involve risks and uncertainties. Such forward-looking information includes statements regarding the potential expansion of the Company's technology to other medical applications. Persons reading this press release are cautioned that such statements or information are only predictions, and that the Corporation's actual future results or performance may be materially different. Factors that could cause actual events or results to differ materially from those suggested by these forward-looking statements include, but are not limited to, product development risks such as regulatory, design, intellectual property, technological and competitor risk and the risk factors described in the Company's reports filed on SEDAR including its Annual Information Form and financial report for the year ended December 31, 2011. These and other factors should be considered carefully and readers should not place undue reliance on such forward-looking information. All forward-looking statements made in this press release are qualified by this cautionary statement and there can be no assurance that actual results or developments anticipated by the Company will be realized. The Company disclaims any intention or obligation to update or revise forward-looking information, whether as a result of new information, future events or otherwise, except as required by law.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.