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DermTech's Non-invasive Melanoma Detection Assay Poised to Enter Clinical Validation Study
Date:11/15/2011

LA JOLLA, Calif., Nov. 15, 2011 /PRNewswire/ -- DermTech, a biotechnology company developing non-invasive molecular diagnostics for disease detection, announced  it will present results from a study showing that its novel melanoma biomarker can be used with a high-throughput, low-cost qRT-PCR platform.  Strong earlier results using microarrays have been recapitulated on a qRT-PCR system that successfully discriminated melanoma with 100% sensitivity and 85% specificity.  Data will be reported at an oral presentation and during a poster session on November 17 at the Association for Molecular Pathology 2011 annual meeting in Grapevine, Texas.

DermTech's MelDTect™ melanoma detection test is based on the Epidermal Genetic Information Retrieval (EGIR®) approach that employs a patented adhesive-based method to obtain cells from the upper layer of the skin and genetic analysis to determine the probability of disease.  

"We saw exciting results using microarrays in our discovery work (Wachsman et al., British Journal of Dermatology, April 2011) and are pleased to report that our breakthrough approach to detecting melanoma is on course for clinical validation," said Sherman Chang, PhD, Senior Director of Molecular Biology. "Thus far in terms of accuracy, these data are better than any known detection product or products in development."

The study to be presented evaluated the suitability of a potential gene expression analysis platform along key parameters, including sensitivity, reproducibility, cost, linear dynamic range and throughput.  Using a qRT-PCR platform, it has been shown that the assays exhibited > 5-log linear dynamic range (LDR) and had a coefficient of variation (CV) < 3%.  Furthermore, 118 EGIR specimens (57 in situ and invasive melanomas, 61 nevi) were analyzed, and the 15-gene classifier was found to have an ROC AUC > 0.912 for discrimination of melanoma from nevi.

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