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Genomic Allergen Rapid Detection test

Topic : Sensitisation

Test Method Number: TM2011-09 (EU)
Short Name of TM: GARD
Year received: 2011
Responsible Organisation: EURL ECVAM - European Union '

Method Description

The Genomic Allergen Rapid Detection (GARD) is a transcriptomics-based in vitro assay proposed to assess the skin sensitisation potential/potency of chemicals.

GARD addresses the third key event of the skin sensitisation Adverse Outcome Pathway (activation of dendritic cells), step 5 (biochemical pathways related to skin sensitisation) and step 6 (immune recognition of chemical allergens and maturation of dendritic cells (DCs)).

The test method has two elements: the so-called GARDskin to assess skin sensitisation potential (first submission in October 2011) and GARDpotency to assess skin sensitisation potency (first submission in July 2018).

The test method is based on the nCounter system and measures the expression level of a panel of genes in the human myeloid cell line MUTZ-3 exposed to chemicals. In GARDskin, the expression of a panel of 200 genes (the GARD Prediction Signature, GPS) is used as input to a prediction...

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Track Approval Status

  • Submission
  • Validation
  • Peer-review
  • Recommendation
  • Regulatory acceptance/Standards
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