GARD®skin Medical Device.

ISO 10993-10:

In vitro skin sensitization testing for medical devices and solid materials

GARDskin 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.

As an adaptation of GARDskin (OECD TG 442E), the assay supports testing of extracts from medical devices and solid materials, classifying test items as either a skin sensitizers or non-sensitizers.

  • Supports both polar and non-polar extraction vehicles (ISO 10993-12).
  • Human-relevant with high predictive accuracy.
  • Fully aligned with the 3Rs.

Powered by genomics and machine learning, the assay is human-relevant and highly accurate, enabling shorter turnaround times compared to traditional animal studies.

Join the shift towards NAMs

As ISO 10993-10 continues to evolve, medical device manufacturers that begin building NAM-based expertise today can strengthen their readiness for future regulatory expectations by:

  • Building internal NAM-relevant databases
  • Gaining hands-on experience interpreting NAM-based results
  • Strengthening weight-of-evidence in regulatory submissions
  • Reducing late-stage regulatory risks
  • Aligning with 3Rs principles and sustainability goals
GET A QUOTE CONNECT WITH SCIENTIFIC EXPERT

Interested in potency information?

GARD®skin Dose-Response can be used for risk assessment of chemicals found during chemical characterization, providing quantitative potency information on skin sensitization.

196 genes

The number of biomarkers used in GARDskin Medical Device.

At a glance

TEST SYSTEM SenzaCell® (human dendritic-like cell line).
What it measures Gene expression profile of 196 genomic biomarkers.
ReadoutSkin sensitizer or non-sensitizer.
Performance94% accuracy*.
ComplianceOECD TG 442E.

ISO 10993-10:2021 Annex C; Final stage ring trial validation ongoing toward full inclusion.

GLP-compliant laboratory.

Turnaround time4-8 weeks for standard studies.
Fast track available.

*Johansson H. et al. Validation of the GARDskin assay for assessment of chemical skin sensitizers – ring trial results of predictive performance and reproducibility. Toxicological Sciences 2019.

How it works

GARDskin Medical Device is an adaptation of the GARDskin assay. The test uses SenzaCell®, a human dendritic-like cell line, which mimics a critical part of the human immune system and is able to recognize allergens. For each test sample, prior to performing the standard GARDskin protocol, an additional extraction step is performed to prepare extracts from the test items (solid materials or final devices) according to ISO 10993-12.

The cells are then exposed to the extracts after which genomic biomarker signature is measured. The gene expression pattern of the exposed cells is compared to existing patterns induced by well-known chemicals and analyzed by pattern recognition and machine-learning technology. As a result, the test item is classified as a sensitizer or non-sensitizer.

All the GARD assays are based on the same technology platform. Read more about the GARD technology platform and assay development principles on the Science page of our website.

Information related to GARDskin Medical Device.

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