LA JOLLA, Calif., Oct. 5, 2016 /PRNewswire/ -- DermTech, Inc., an emerging diagnostics company focusing on non-invasive gene expression tests for skin cancer and inflammatory diseases, announced today the publication of the "Development and Validation of a Non-Invasive 2-Gene Molecular Assay for Cutaneous Melanoma", in the Journal of the American Academy of Dermatology (Ms.No. JAAD-D-16-00647R1) with online access available now at http://www.jaad.org/inpress.
This validation study sought to provide clinicians with a differentiated and accurate noninvasive diagnostic modality. A 2-gene classification method based on LINC00518 and preferentially expressed antigen in melanoma gene expression (PRAME) was evaluated and validated in 555 pigmented lesions (157 training and 398 validation samples) obtained noninvasively via adhesive patch biopsy.
Results were compared with standard histopathologic assessment in lesions with a consensus diagnosis among 3 experienced dermatopathologists. In 398 validation samples, LINC00518 and/or PRAME detection appropriately differentiated melanoma from non-melanoma samples with a sensitivity of 91% and a specificity of 69%. LINC00518 and PRAME were established in both melanoma samples obtained via non-invasive adhesive patch biopsy and underlying FFPE samples of surgically excised primary melanomas and in melanoma lymph node metastases.
The clinical study's lead author Dr. Pedram Gerami, a Professor of Dermatology at Northwestern University's Feinberg School of Medicine (Chicago, IL) and an internationally recognized melanoma specialist, noted: 'Clinical and histopathologic assessment of pigmented skin lesions is challenging even for experts. This newly published validation study demonstrates how our non-invasive pigmented lesion assay classifies clinically difficult to differentiate pigmented lesions into melanoma and non-melanoma groups. It offers dermatologists a tool to help with diagnostic challenges that may be inherently linked to the visual image and pattern recognition approach.'
DermTech is a commercial stage molecular dermatology company developing non-invasive gene expression tests to aid the clinical diagnosis of skin cancer and inflammatory skin conditions. DermTech operates a CLIA licensed and CAP accredited laboratory in the company's La Jolla, CA headquarters. DermTech's technology allows the analysis of skin biopsy samples collected non-invasively using an adhesive patch. DermTech provides highly accurate, objective information to the physicians to improve care and reduce costs. Current dermatologic diagnosis is primarily based on subjective visual pattern recognition that is prone to error and results in a substantial number of unnecessary surgical procedures. For additional information visit: www.dermtech.com.
Sarah Dennison, MBA
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SOURCE DermTech, Inc.