DermTech's Non-invasive Melanoma Detection Assay Poised to Enter Clinical Validation Study
Data Translates to High-throughput qRT-PCR Platform, Shows 100% Sensitivity
Published: Tuesday, Nov. 15, 2011 - 5:11 am
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 MelDTectTM 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.
"The results, especially with respect to linear dynamic range, far exceed anything we've seen using microarrays and suggest that the non-invasive assay will perform extremely well in a high-volume clinical setting," said Bill Wachsman, MD, PhD, VA San Diego and UCSD, and a member of DermTech's Scientific Advisory Board. "Since melanoma is highly curable if caught early, the goal is to develop a test that is highly sensitive, objective, and cost effective. This assay meets these criteria and should be readily adopted."
DermTech's pre-validation study is expected to begin enrollment at clinical sites in Europe in early Q2 2012. The study will evaluate use of the MelDTect test on a high throughput qRT-PCR platform in a broader population.
Headquartered in La Jolla, California, DermTech is focused on the development of the company's patented Epidermal Genetic Information Retrieval (EGIR) technology. The EGIR technology uses a custom adhesive tape to non-invasively and easily collect cells from the stratum corneum, i.e., the upper layer of the skin. The RNA from these cells is then isolated, amplified and analyzed using molecular biology tools to determine genetic profiles to be used for a range of applications including: non-invasive disease detection, personalized medicine and pharmaceutical R&D. DermTech is actively pursuing research in the areas of melanoma, prostate cancer and other diseases and a number of skin conditions. For additional information visit: www.dermtech.com.
Since 1930, there has been a 2000 times increase in the lifetime risk of developing melanoma. By 2010, current estimates indicate 1 out of 50 people will be diagnosed with melanoma during their lifetime. (1) Melanoma is the most common cancer in women aged 25-29. 5% to 10% of cases of cutaneous melanoma are the result of hereditary genetics in first-degree relatives. (2) Unlike most other cancers, melanoma only infrequently responds to treatment and those available are highly toxic, impact quality of life.(3) If melanoma is treated before it spreads, it is 99% curable. (4) The ten-year survival rate for melanoma patients whose disease is detected and treated at the earliest stages is 95-99% but drops to less then 5% if for a Stage 4 melanoma (invasive).(5)
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