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Aiming for CLIA Certification, DermTech Begins Validation of Melanoma Test


DermTech said this week that it has begun commercial validation testing of its proprietary pigmented lesion assay, a non-invasive qPCR-based test for melanoma.

The San Diego-based company recently completed the build-out of a commercial laboratory space in nearby La Jolla, Calif. The company needs to complete analytical and clinical validation studies of its assay in order to receive regulatory certification under CLIA requirements.

DermTech recently raised $5.6 million in a Series B financing led by Jacobs Investment Company, and will use a portion of these funds to complete the validation of its assays.

The company's assays analyze the expression level of multiple gene targets using Life Technologies' OpenArray quantitative real-time PCR system (PCR Insider 8/22/2013). DermTech's initial assay will identify expression consistent with melanoma. The test uses an adhesive-patch method to collect cells from pigmented lesions including melanomas, allowing for non-invasive sample collection.

DermTech is conducting the validation studies in collaboration with Northwestern University and the University of Pittsburgh Medical Center.