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Updated: Apr 15, 2026

DNA-barcode-based Multiplex Immunofluorescence Imaging to Analyze FFPE Specimens from Genetically Reprogrammed Murine Melanoma
Published on: June 6, 2025
Analytical validation of a melanoma diagnostic gene signature using formalin-fixed paraffin-embedded melanocytic
M Bryan Warf1, Darl D Flake1, Doug Adams1
11Myriad Genetic Laboratories, Inc., 320 Wakara Way, Salt Lake City, UT 84108, USA.
Aim:
These studies were to validate the analytical performance of a gene expression signature that differentiates melanoma and nevi, using RNA expression from 14 signature genes and nine normalization genes that generates a melanoma diagnostic score (MDS).
Materials & Methods:
Formalin-fixed paraffin-embedded melanocytic lesions were evaluated in these studies.
Results:
The overall SD of the assay was determined to be 0.69 MDS units. Individual amplicons within the signature had an average amplification efficiency of 92% and a SD less than 0.5 CT. The MDS was reproducible across a 2000-fold dilution range of input RNA. Melanin, an inhibitor of PCR, does not interfere with the signature.
Conclusion:
These studies indicate this signature is robust and reproducible and is analytically validated on formalin-fixed paraffin-embedded melanocytic lesions.

