Data on DermTech's Non-invasive Test for Melanoma are Published in the British Journal of Dermatology

LA JOLLA, California, February 7, 2011 /PRNewswire/ --

- Genomic Test is 100% Sensitive -

DermTech International, Inc., a biotechnology company dedicated to bringing genomic medicine to dermatologists, today announced that the discovery data on its new genomic assay for melanoma have been published in the British Journal of Dermatology. The test is based on the EGIR(TM) technology (Epidermal Genetic Information Retrieval) that non-invasively collects cells from the skin's surface using a custom adhesive. Details from the paper titled "Non-invasive Genomic Detection of Melanoma" show that the test is 100% sensitive in identifying melanoma.

The EGIR-based technology assessed pigmented skin lesions thought to be suspicious for melanoma and identified all the lesions containing either in situ (early stage) or invasive disease correctly 100% of the time. The test registers 88% specificity (12% false positives). These results are more accurate than any currently available melanoma detection tool. The study was performed at 18 sites across the United States.

"Once the technology becomes available for clinical use, dermatologists will be able to detect the presence of melanoma at the molecular level using a simple process, instead of deciding to take a 'wait and see' approach on lesions that may not look overly suspicious, but could well be early melanomas," said Rainer Hofmann-Wellenhof, MD, Medical University of Graz. "The melanoma test in development by DermTech appears to provide important adjunctive information for the evaluation of pigmented lesions," added Susana Puig, MD, PhD, University Hospital Clinic of Barcelona. "Because this method of sample collection is non-invasive, I would expect that dermatologists will be able to use this test to evaluate a fuller spectrum of lesions on a patient. Additionally, by limiting the number of biopsies required, it appears that the new test may help reduce health care costs. Finally, the technique may facilitate recognizing the genetic information of the tumor before the excision."

The paper shows that the EGIR method, which uses adhesive to harvest cells from the skin, identified genes that were differentially expressed in melanomas versus normal skin and nevi. Class prediction modeling identified a 17-gene biomarker that detects both in situ and invasive disease. As part of the year-long multi-center study, 202 total lesional samples were collected (samples included superficial spreading melanoma, nodular melanoma and lentigo maligna, often misdiagnosed as solar lentigo, a sun spot).

"Worldwide, the incidence rate of melanoma is climbing faster than any other cancer," said Daniel M. Siegel, MD, incoming President-Elect of the American Academy of Dermatology. "Accurate detection remains the most significant challenge that dermatologists face daily in their practices. Early detection and full excision with proper margins is the only cure for this disease and dermatologists will benefit from tools that help them identify all instances of melanoma. The EGIR technology in development appears to be a major step in this direction."

The current standard of care, an invasive biopsy followed by histopathologic evaluation, typically reveals the presence of melanoma just 3.5-5% of the time. The marked increase in specificity of the genomic test may better identify which of the patient's lesions contain melanoma, effectively helping to direct biopsies.

Many experts believe that, in addition to limiting invasive procedures, the genomic test may be more accurate than today's detection methods. In one case, as reported in the paper, a lesion that was read to be benign by standard review of histopathology was called positive for melanoma using the biomarker-based test. The patient's tissue was then serial sectioned and re-examined by the pathologists, at which time invasive melanoma was diagnosed.

DermTech is now translating these discovery data onto a quantitative PCR platform. Preliminary results suggest the feasibility of using this 17-gene biomarker in a clinical laboratory setting. Additional sample collection activities are ongoing in the US, Australia and Europe.

"If these findings are confirmed in an expanded clinical validation study, it would establish the EGIR-based assay as a more accurate and cost effective alternative to the currently available tools for melanoma detection," said George Schwartz, CEO, DermTech.

About DermTech International Inc.:

Headquartered in La Jolla, California, DermTech is focused on the development of the company's patented Epidermal Genetic Information Retrieval (EGIR(TM)) 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. Genetic material (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: the non-invasive, early detection of disease, pharmaceutical R&D and theranostics. DermTech is actively pursuing research using the EGIR technology in the areas of melanoma, prostate cancer and a number of skin conditions. For additional information visit: http://www.dermtech.com.

About Melanoma:

Since 1930, there has been a 2000 times increase in the lifetime risk of developing melanoma. By 2010, current estimates indicate that 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 that are available are highly toxic and 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% for a Stage 4 melanoma (invasive)(5).

    
    (1) CA Cancer J Clin 2008
    (2) Karolinska Institute, Aug 2008
    (3) NCI Melanoma Treatment Options
    (4) AAD Fact Sheet 2007
    (5) American Joint Committee on Cancer - AJCC.

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    Contacts:
    DermTech
    George Schwartz, CEO
    +1-858-450-4222
 
    For DermTech
    Jennifer Larson
    +1-415-725-2017
    jlarson@dermtech.com