title: Analytical validation of a melanoma diagnostic gene signature using formalin-fixed paraffin-embedded melanocytic lesions.
abstract: OBJECTIVE
  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).
  
  
  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.
  
  
  CONCLUSIONS
  These studies indicate this signature is robust and reproducible and is analytically validated on formalin-fixed paraffin-embedded melanocytic lesions.
authors: 1Myriad Genetic Laboratories, Inc., 320 Wakara Way, Salt Lake City, UT 84108, USA.
authors: M Bryan
authors: MB
authors: Warf
authors: 1Myriad Genetic Laboratories, Inc., 320 Wakara Way, Salt Lake City, UT 84108, USA.
authors: Darl D
authors: DD
authors: Flake
authors: 1Myriad Genetic Laboratories, Inc., 320 Wakara Way, Salt Lake City, UT 84108, USA.
authors: Doug
authors: D
authors: Adams
authors: 1Myriad Genetic Laboratories, Inc., 320 Wakara Way, Salt Lake City, UT 84108, USA.
authors: Alexander
authors: A
authors: Gutin
authors: 1Myriad Genetic Laboratories, Inc., 320 Wakara Way, Salt Lake City, UT 84108, USA.
authors: Kathryn A
authors: KA
authors: Kolquist
authors: 1Myriad Genetic Laboratories, Inc., 320 Wakara Way, Salt Lake City, UT 84108, USA.
authors: Richard J
authors: RJ
authors: Wenstrup
authors: 1Myriad Genetic Laboratories, Inc., 320 Wakara Way, Salt Lake City, UT 84108, USA.
authors: Benjamin B
authors: BB
authors: Roa
mesh_terms: D005557:Formaldehyde / Q000737:chemistry*; D006801:Humans; D008545:Melanoma / Q000378:metabolism*; D009506:Nevus / Q000378:metabolism; D010232:Paraffin / Q000737:chemistry*; D016133:Polymerase Chain Reaction; D012313:RNA / Q000378:metabolism
chemical_list: D005557:Formaldehyde; D012313:RNA; D010232:Paraffin
keywords: FFPE; analytical validation; diagnosis; gene expression; melanoma; quantitative RT-PCR