SAN DIEGO--(BUSINESS WIRE)--DermTech, a privately held biotechnology company developing and commercializing qPCR assays for skin samples collected non-invasively using adhesive patch methods, announced today it has initiated commercial validation testing of its proprietary pigmented lesion assay. The Company recently completed the build-out of a commercial laboratory space on 11099 N. Torrey Pines Road, La Jolla, CA. The analytical and clinical validation studies are required for regulatory certification following CLIA (Clinical Laboratory Improvement Amendments) requirements. The CLIA federal regulatory standards require clinical laboratories to establish and document their performance specifications for laboratory-developed tests to ensure accurate and precise results prior to implementation of the test. The performance characteristics that must be established include accuracy, precision, reportable range, reference interval, analytical sensitivity, and analytical specificity. A recent Series B financing led by Jacobs Investment Company LLC will be partially used to complete these efforts.
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