title: Evaluation of the GARD assay in a blind Cosmetics Europe study.
abstract: Chemical hypersensitivity is an immunological response towards foreign substances, commonly referred to as sensitizers, which gives rise primarily to the clinical symptoms known as allergic contact dermatitis. For the purpose of mitigating risks associated with consumer products, chemicals are screened for sensitizing effects. Historically, such predictive screenings have been performed using animal models. However, due to industrial and regulatory demand, animal models for the purpose of sensitization assessment are being replaced by non-animal testing methods, a global trend that is spreading across industries and market segments. To meet this demand, the Genomic Allergen Rapid Detection (GARD) assay was developed. GARD is a novel, cell-based assay that utilizes the innate recognition of xenobiotic substances by dendritic cells, as measured by a multivariate readout of genomic biomarkers. Following cellular stimulation, chemicals are classified as sensitizers or non-sensitizers based on induced transcriptional profiles. Recently, a number of non-animal methods were comparatively evaluated by Cosmetics Europe, using a coherent and blinded test panel of reference chemicals with human and local lymph node assay data, comprising a wide range of sensitizers and non-sensitizers. The outcome of the GARD assay is presented in this paper. It was demonstrated that GARD is a highly functional assay with a predictive performance of 83% in this Cosmetics Europe dataset. The average accumulated predictive accuracy of GARD across independent datasets was 86% for skin sensitization hazard.
authors.affiliation: SenzaGen AB, Lund, Sweden.
authors.forename: Henrik
authors.initials: H
authors.lastname: Johansson
authors.affiliation: SenzaGen AB, Lund, Sweden.
authors.forename: Robin
authors.initials: R
authors.lastname: Gradin
authors.affiliation: Dept. of Immunotechnology, Lund University, Lund, Sweden.
authors.forename: Andy
authors.initials: A
authors.lastname: Forreryd
authors.affiliation: SenzaGen AB, Lund, Sweden.
authors.forename: Maria
authors.initials: M
authors.lastname: Agemark
authors.affiliation: Dept. of Immunotechnology, Lund University, Lund, Sweden.
authors.forename: Kathrin
authors.initials: K
authors.lastname: Zeller
authors.affiliation: SenzaGen AB, Lund, Sweden.
authors.forename: Angelica
authors.initials: A
authors.lastname: Johansson
authors.affiliation: SenzaGen AB, Lund, Sweden.
authors.forename: Olivia
authors.initials: O
authors.lastname: Larne
authors.affiliation: Cosmetics Europe - The Personal Care Association, Brussels, Belgium.
authors.forename: Erwin
authors.initials: E
authors.lastname: van Vliet
authors.affiliation: Dept. of Immunotechnology, Lund University, Lund, Sweden.
authors.forename: Carl
authors.initials: C
authors.lastname: Borrebaeck
authors.affiliation: Dept. of Immunotechnology, Lund University, Lund, Sweden.
authors.forename: Malin
authors.initials: M
authors.lastname: Lindstedt
mesh_terms: D000485:Allergens / Q000633:toxicity*; D000826:Animal Testing Alternatives; D000818:Animals; D001681:Biological Assay; D015415:Biomarkers / Q000032:analysis; D045744:Cell Line, Tumor; D003358:Cosmetics / Q000633:toxicity*; D017449:Dermatitis, Allergic Contact / Q000209:etiology / Q000235:genetics / Q000276:immunology; D005060:Europe; D006801:Humans; D012867:Skin; D014158:Transcription, Genetic / Q000187:drug effects / Q000276:immunology
chemical_list: D000485:Allergens; D015415:Biomarkers; D003358:Cosmetics
keywords:  GARD;  alternative methods;  in vitro;  sensitization; predictive accuracy