SAN DIEGO--(BUSINESS WIRE)--DermTech International, Inc. (“DermTech”), a privately held molecular diagnostics company commercializing non-invasive gene expression tests for dermatology, announced today that it has completed validation testing of its proprietary Pigmented Lesion Assay (PLA) and completed California CLIA licensure of its San Diego laboratory facility.
Clinical and pathologic evaluation of pigmented skin lesions (benign nevi or moles and malignant melanoma) is subjective and can lead to a significant number of unnecessary surgical biopsies and potential diagnostic inaccuracies. DermTech’s Pigmented Lesion Assay provides objective information on gene expression associated with melanoma and can be used on samples collected with an adhesive patch rather than a scalpel. This information can be used to help the clinician non-invasively assess the need for a surgical biopsy and to support the pathologic diagnosis.
The development of DermTech’s Pigmented Lesion Assay has involved over 500 lesion samples including over 250 melanomas. The expression profile was developed by screening the entire genome for differential gene expression between melanoma and non-melanoma pigmented skin lesions (British Journal of Dermatology, 2011). The performance of the 2-gene expression profile was elucidated in a series of three studies examining 288 lesions with over 140 melanomas. The PLA score, which is determined from the expression levels of these two genes, steadily increases from non-melanoma lesions, to melanoma in situ, to invasive melanoma, demonstrating progression of gene expression changes as melanoma advances. The average score of a melanoma, or melanoma in situ, is statistically significantly different from non-melanoma (p < 0.00001).
In two validation studies comparing the 2-gene expression profile to histopathology diagnosis (n=158), the PLA demonstrated 91% accuracy in identifying non-melanoma and melanoma lesions, with a sensitivity of 93% and a specificity of 90%. At a projected melanoma prevalence of 7%, the negative predictive value was greater than 99%. Studies have shown that the current standard clinical assessment of pigmented lesions demonstrates an accuracy of less than 20% with sensitivities ranging from 70-80% and specificities ranging from 5-20%.
Laura Korb Ferris, M.D., Ph.D., Associate Professor at the University of Pittsburgh Department of Dermatology and Director of the Pigmented Lesion Clinic, commented, “DermTech is at the forefront of bringing objective tumor biology markers to dermatology, which has historically relied on subjective pattern recognition for diagnosis. Melanoma is a particularly challenging diagnostic area where DermTech’s Pigmented Lesion Assay can fill a significant unmet need.”
Pedram Gerami, M.D., Associate Professor of Dermatology at Northwestern University and the Co-Director of Melanoma Research at the Northwestern Skin Cancer Institute, also noted, “This is an important first step for the introduction of this exciting technology. DermTech’s gene classifier has the potential to facilitate the assessment of pigmented lesions and significantly reduce surgical biopsies.”
DermTech is a molecular diagnostics company headquartered in La Jolla, California, that is transforming dermatologic diagnosis through the development of novel gene expression tests to aid the identification of different skin conditions, including melanoma. Importantly, the tests can be used on skin samples collected non-invasively with an adhesive patch rather than a scalpel. Current dermatologic diagnosis, primarily based on pattern recognition, is subjective, and prone to error. In contrast, DermTech’s tests provide objective, biologic information that is highly accurate. For additional information visit: www.dermtech.com