SENS-IS® | IN VITRO SKIN SENSITIZATION
Any Product. Quantitative Answers.
Direct testing on reconstructed human epidermis — from simple ingredients to complex finished products.
Why SENS-IS® Makes the Difference
One in vitro skin sensitization assay. Two major advantages.
What is SENS-IS?
SENS-IS® is an in vitro skin sensitization assay developed by ImmunoSearch to assess the sensitizing potential and potency of chemicals and products.
The assay combines IS-SKIN™, a reconstructed human epidermis model, with gene expression analysis. Test substances are applied directly to the surface of the 3D epidermis, allowing the biological response of human skin tissue to be measured after exposure.
SENS-IS analyzes the expression of 61 biomarkers covering sensitization, REDOX/ARE pathways and irritation. This genomic response provides more than a positive/negative result: it generates a biological signature that can help distinguish sensitization from irritation and characterize the response to the tested substance.
Because substances are applied topically to reconstructed epidermis, SENS-IS can accommodate a broad range of test materials, including poorly soluble and lipophilic substances, complex mixtures and finished products.
What SENS-IS tells you
SENS-IS goes beyond a simple positive or negative result. By analyzing the genomic response of the tissue, the assay provides three complementary levels of information.
Hazard identification
Determines whether a substance or product triggers a skin sensitization response.
Potency assessment
Testing across concentrations identifies the lowest concentration triggering a sensitization response. This concentration can be used as a Point of Departure (PoD) for risk assessment, analogous to the EC3 derived from the LLNA, while being obtained from a human reconstructed epidermis model.
Biological signature
The pattern of gene activation reveals how the tissue responds to the tested substance. Sensitization, REDOX/ARE and irritation biomarkers provide a biological fingerprint that can help distinguish different response profiles.
Together, these data provide a more comprehensive characterization of skin sensitization potential than a binary hazard result alone.
Validated performance
SENS-IS has been evaluated through extensive validation studies, including interlaboratory testing, demonstrating high reproducibility and predictive performance for skin sensitization hazard identification.
Up to 98%
Within-laboratory reproducibility
Up to 96%
Between-laboratory reproducibility
95%
Hazard prediction accuracy
Performance varies according to the validation dataset. See published studies for detailed results.
Performance has been demonstrated across independent laboratories and multiple datasets, supporting the robustness and transferability of the method.
Regulatory recognition
SENS-IS has progressed from scientific validation to international regulatory evaluation.
The method has undergone extensive validation and interlaboratory evaluation and is included in the OECD Test Guidelines Programme for skin sensitization hazard identification. SENS-IS is also registered in the EURL ECVAM Tracking System for Alternative methods towards Regulatory acceptance (TSAR).
ImmunoSearch operates SENS-IS under Good Laboratory Practice (GLP) for regulatory skin sensitization studies, providing a quality-assured framework for studies intended to support regulatory safety assessment.
The regulatory method is validated specifically with IS-SKIN™, ImmunoSearch’s proprietary reconstructed human epidermis model.
Trusted by industry. Supported by science.
From collaborative research to independent evaluations, SENS-IS® has been investigated by leading industrial companies and scientific organizations across diverse sectors.
When conventional testing is not enough
Some skin sensitization questions require more than standard testing approaches. Discover how SENS-IS® can help address four common challenges in product safety assessment.
Conflicting Results
When different assays give different answers.
Complex Formulations
When the finished product behaves differently from its ingredients.
Challenging Substances
When solubility or physicochemical properties limit conventional 2D testing.
Beyond Hazard
When risk assessment requires quantitative information.