Noninvasive Genomic Assay Detects Early-Stage Melanoma

A non-invasive assay is being tested for its ability to distinguish melanoma from benign moles.

A biomarker based on 20 target genes is being developed as part of a molecular-based approach that uses its Epidermal Genetic Information Retrieval (EGIR) technology to identify melanoma at the earliest stages of disease. The EGIR ("tape stripping”) method is based on applying a custom adhesive strip to the skin's surface to obtain RNA and subsequently using gene expression profiling techniques to identify disease.

Although melanoma accounts for more than 70% of skin cancer deaths, when detected early it is considered highly curable. In current clinical practice, the detection of melanoma is based upon visual clinical cues including the "ABCDE” criteria for pigmented nevi and results of optical imaging techniques, such as dermoscopy and confocal microscopy. However, depending upon the setting, only 1-10% of lesions biopsied for suspicion of melanoma are positive upon histopathologic examination. Thus, there is a substantial need for a test that enhances the ease and accuracy of melanoma detection.

"Results of this study suggest that the malignant melanocyte, directly or indirectly, induces an alteration in stratum corneum gene expression,” said Sherman Chang, Ph.D., director of molecular biology, DermTech International (La Jolla, CA, USA), the company that developed the test. "These findings pave the way for the development of an objective assay based on genomic data--a major advance over today's subjective method of identifying disease.”

DermTech International is focused on the development and validation of molecular tests using specimens obtained from the skin. The company's EGIR technology is being evaluated in clinical studies for its potential as a noninvasive diagnostic for melanoma and other major diseases. It is also being studied in the context of tracking treatment efficacy for a variety of dermatologic and other conditions, including the effects of drugs on skin at the molecular level in advance of observable clinical results.


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