Regulatory and Licensing

DermTech is fully licensed under the Clinical Laboratory Improvement Amendment of 1988 (“CLIA”), as well as accredited by the College of American Pathologists. In addition, DermTech maintains all necessary licenses required by all states in which it provides services.

Licenses

CLIA
California
Maryland
New York
Pennsylvania
Rhode Island

Accreditations

CAP Accreditation

The DermTech Melanoma Test is a physician-ordered laboratory developed test (LDT) and is regulated under the Clinical Laboratory Improvement Amendments (CLIA). DermTech’s laboratory is qualified to perform high complexity testing, developed and analytically validated the LDT in accordance with CLIA standards, and is also accredited by the College of American Pathologists and New York Dept. of Health. The DermTech Melanoma Test is not reviewed or approved by the FDA.

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