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DermTech Gets CLIA Certification, Validates Melanoma Test

NEW YORK (GenomeWeb News) — DermTech International said today that it has completed California CLIA licensure of its San Diego laboratory facility.

The company also said that it has completed validation testing of its proprietary Pigmented Lesion Assay (PLA), which it plans to offer as a laboratory-developed test out of its CLIA lab.

DermTech's PLA gauges expression of two genes associated with melanoma and can be used on samples collected with an adhesive patch rather than a scalpel. The information can be used to help clinicians non-invasively assess the need for a surgical biopsy and to support pathological diagnosis.

DermTech and collaborators elucidated the performance of PLA in a series of three studies examining 288 lesions with more than 140 melanomas. In two validation studies comparing the two-gene expression profile to histopathology diagnosis, the PLA demonstrated 91 percent accuracy in identifying non-melanoma and melanoma lesions, with a sensitivity of 93 percent and a specificity of 90 percent. Studies have shown that the current standard clinical assessment of pigmented lesions demonstrates an accuracy of less than 20 percent with sensitivities ranging from 70 to 80 percent and specificities ranging from 5 to 20 percent, the company said.