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Evaluation of the GARD assay in a blind cosmetics Europe study

Johansson, Henrik LU ; Gradin, Robin LU ; Forreryd, Andy LU ; Agemark, Maria LU ; Zeller, Kathrin LU orcid ; Johansson, Angelica ; Larne, Olivia LU ; Van Vliet, Erwin ; Borrebaeck, Carl LU and Lindstedt, Malin LU (2017) In ALTEX Alternatives To Animal Experimentation 34(4). p.515-523
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,... (More)

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.

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author
; ; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Alternative methods, GARD, In Vitro, Predictive accuracy, Sensitization
in
ALTEX Alternatives To Animal Experimentation
volume
34
issue
4
pages
9 pages
publisher
Spektrum Akad Verlag
external identifiers
  • scopus:85035773204
  • pmid:28214915
  • wos:000414297700005
ISSN
1868-596X
DOI
10.14573/altex.1701121
language
English
LU publication?
yes
id
1017c565-7a63-4383-9a8e-ce82f613c5e6
date added to LUP
2017-12-12 14:43:46
date last changed
2024-04-15 00:11:04
@article{1017c565-7a63-4383-9a8e-ce82f613c5e6,
  abstract     = {{<p>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.</p>}},
  author       = {{Johansson, Henrik and Gradin, Robin and Forreryd, Andy and Agemark, Maria and Zeller, Kathrin and Johansson, Angelica and Larne, Olivia and Van Vliet, Erwin and Borrebaeck, Carl and Lindstedt, Malin}},
  issn         = {{1868-596X}},
  keywords     = {{Alternative methods; GARD; In Vitro; Predictive accuracy; Sensitization}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{515--523}},
  publisher    = {{Spektrum Akad Verlag}},
  series       = {{ALTEX Alternatives To Animal Experimentation}},
  title        = {{Evaluation of the GARD assay in a blind cosmetics Europe study}},
  url          = {{http://dx.doi.org/10.14573/altex.1701121}},
  doi          = {{10.14573/altex.1701121}},
  volume       = {{34}},
  year         = {{2017}},
}