GARD® Assay services

• • GARD®skin: A skin sensitization assay that provides a binary answer for the safety assessment of chemicals. Approved by OECD for regulatory testing. As a new method included in OECD TG 442E for in vitro skin sensitization, GARD®skin supports discrimination of skin sensitizers and non-sensitizers in accordance with the UN GHS.
  • GARD®potency: An add-on assay to GARD™skin, subcategorizing sensitizers according to CLP/GHS classifications, determining their potency. It is an approved test method included in the OECD Test Guideline Program (TGP 4.106). It has gained recognition and acceptance from regulatory bodies such as the European Chemicals Agency (ECHA). As a result, the results obtained from GARDpotency can be utilized as weight-of-evidence in REACH dossiers for sub-categorization of confirmed skin sensitizers into 1A or 1B according to the GHS/CLP system
  • GARD®air: A respiratory sensitization assay that offers a binary answer for the safety assessment of chemicals.
  • GARD®skin Medical Device: Offers an in vitro alternative for skin sensitization testing as a part of the Biological Evaluation of Medical Devices according to ISO 10993
  • GARD®skin Dose-Response: A skin sensitization testing assay that provides quantitative potency assessment.

How does GARD® Assay work?

These assays are based on the Genomic Allergen Rapid Detection (GARD) platform, which uses SenzaCell, a human myeloid leukemia cell line acting as an in vitro model of human Dendritic Cells (DCs). By examining the transcriptional responses of SenzaCells following exposure to chemicals, the company has identified a set of genes relevant to specific hazard properties.

Using NanoString nCounter technology, the expression levels of these genes are quantified to derive a decision value (DV) from a Support Vector Machine prediction model. This technology provides accurate and reliable results for safety assessment.

Our Promise

At GVRP, we strive for innovation through collaboration. By integrating the GARD® Assay suite into your workflows, you can enhance product safety, ensure regulatory compliance, and mitigate risks associated with sensitization issues. Experience the exceptional predictability of GARD® Assay services and benefit from the advanced in vitro testing methods that reflect human biology accurately.

Join us in shaping a future where safety standards are elevated, regulatory compliance is facilitated, and innovative solutions are fostered.