Introducing SENS-IS: The Future of Ethical and Accurate Skin Sensitization Testing

The SENS-IS assay is designed to revolutionize skin sensitization testing by replacing the Local Lymph Node Assay (LLNA). This innovative assay offers a more relevant and accurate determination of hazards in human data. According to a recent publication by the Research Institute for Fragrance Materials (RIFM), the SENS-IS assay is at least equally effective in determining skin sensitization potency. Traditional LLNA testing faces several challenges, including ethical concerns over animal use and the variability of interspecies responses. The SENS-IS assay addresses these issues by providing a human-relevant alternative, ensuring more accurate and humane results. By delivering results consistent with human biology, the SENS-IS assay enhances data reliability, supporting better regulatory and safety decisions. It aligns with the growing demand for non-animal testing methods, meeting both regulatory and societal expectations. Experience the significant advancements in skin sensitization testing with SENS-IS, offering a more ethical, accurate, and human-relevant alternative to the LLNA.

High Relevance to Human Biology

The SENS-IS assay is transforming skin sensitization testing by offering a more accurate and humane alternative to traditional methods. Designed to replace the Local Lymph Node Assay (LLNA), it leverages a reconstructed human epidermis model that closely mimics real human skin. This high level of biological relevance ensures precise and pertinent results, addressing the limitations of animal models and enhancing hazard assessments.

A standout feature of the SENS-IS assay is its use of a 3D epidermis model, allowing the direct application of any product type to the skin surface. This eliminates solubility issues and enables testing of products exactly as they will be used commercially. Products can be tested in their pure form with various exposure times, providing a true-to-life evaluation of their effects.

This innovative approach not only replicates the complexity of human skin but also provides detailed insights into how chemicals interact with human tissues. The SENS-IS assay delivers results consistent with human biology, supporting better regulatory and safety decisions. It ensures that data generated is highly reliable and applicable to human health.

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High specificity

Experience the unmatched specificity of the SENS-IS assay, designed to target key molecular pathways involved in skin sensitization, such as the Keap1-Nrf2-ARE pathway and dendritic cell activation signals. This high level of specificity allows for a deeper understanding of the mechanisms underlying skin sensitization.

By focusing on these well-defined pathways, the SENS-IS assay accurately pinpoints the biological processes affected by different chemicals. Subtle differences between sensitizing agents become apparent, offering clarity that less specific methods might miss.

The SENS-IS assay analyzes a broad panel of genes, enhancing its ability to detect various sensitizing agents and providing a robust assessment of skin sensitization potential. This comprehensive approach identifies multiple biological responses triggered by different chemicals, offering a complete picture of their sensitizing properties. By examining a wide range of genes, the assay captures the complexity of skin sensitization mechanisms, which often involve multiple pathways and responses.

This broad gene panel increases the sensitivity and specificity of the assay, making it more effective in identifying potential sensitizers, including low-level sensitizers that might be missed by assays with a narrower focus. 

The assay's targeted approach refines predictive models used in safety assessments, enhancing their accuracy and reliability. This ensures a comprehensive evaluation of skin sensitization potential, making it an essential tool for safety evaluations.

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Quantitative and Reproducible

The SENS-IS assay utilizes RT-PCR for gene expression analysis, providing precise and quantitative measurements that set new standards in skin sensitization testing. This method ensures reproducible results, consistently achieved across different laboratories and studies, enhancing scientific credibility and regulatory acceptance.

Experience the benefits of RT-PCR's quantitative nature, delivering accurate and reliable data essential for regulatory safety assessments. The reproducibility of the SENS-IS assay is a cornerstone of its value, offering unmatched reliability for various applications, from basic research to regulatory compliance.

With the ability to perform high-throughput screening, the SENS-IS assay can analyze multiple samples simultaneously, accelerating research and development processes. This efficiency reduces the time and cost associated with safety testing, making it an invaluable asset for your projects.

The quantitative data provided by the SENS-IS assay also helps establish dose-response relationships, further informing risk assessment and regulatory decisions. 

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The SENS-IS assay is designed to test chemicals in various forms, whether pure or dissolved in solvents like Phosphate Buffered Saline (PBS), olive oil, DMSO, or Dipropylene Glycol. This versatility ensures the assay's applicability to a wide range of substances, even those challenging to test with other methods.

By accommodating different chemical forms, the SENS-IS assay can handle various formulations and product types, making it relevant across multiple industries. It allows for testing in conditions that closely mimic real-world use scenarios, providing more realistic and applicable safety assessments.

The flexibility of the SENS-IS assay supports the evaluation of a broader spectrum of chemicals, including those with unique properties or solubility characteristics. This adaptability makes it a valuable tool for comprehensive safety testing, addressing diverse testing needs.

Whether you're testing drugs, medical devices, household products, individual ingredients, mixtures, or finished products, the SENS-IS assay delivers reliable results. Its versatility ensures it meets the demands of various industries and applications.

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Rapid turn over

The SENS-IS assay offers a remarkable advantage: it delivers results significantly faster than traditional in vivo methods. This swift turnaround is a game-changer for product development and safety evaluation, where time is of the essence. In industries like cosmetics, pharmaceuticals, and chemicals, timely safety assessments are crucial. Faster results mean quicker decisions about product safety and market readiness, slashing the time-to-market for new innovations. The SENS-IS assay's rapid testing capabilities allow for more iterative testing during development, enabling prompt adjustments and improvements.

Despite its speed, the SENS-IS assay maintains high accuracy and reliability, ensuring that rapid results do not compromise the quality of safety assessments. This efficiency is invaluable in situations demanding urgent safety evaluations, such as regulatory inquiries or emerging safety concerns.

The benefits of the SENS-IS assay span across various industries. In cosmetics, speedy safety evaluations mean faster launches of new beauty products. In pharmaceuticals, a quick turnaround supports agile development and testing cycles. In chemicals, rapid assessments ensure compliance and safety in dynamic environments. The SENS-IS assay stands out as an efficient and effective tool for skin sensitization testing, making it an essential asset in today's fast-paced product development landscape. Experience the benefits of rapid, reliable results and enhance your product development process with the SENS-IS assay.

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Substance Testability

The SENS-IS assay excels in testing substances that are notoriously difficult to assess. When used to evaluate functional polysiloxanes and silanes, the SENS-IS assay demonstrated consistent and accurate predictions compared to in vivo methods like LLNA and GPMT, as well as other in vitro assays such as DPRA, KeratinoSens™, h-CLAT, and mMUSST (Petry, T. Regulatory Toxicology and Pharmacology 98 (2018) 209–214).

The SENS-IS assay not only matched the in vivo results but often surpassed other in vitro tests in predictive capability. It accurately forecasted the sensitization potential of polysiloxanes and silanes, including their potency, aligning closely with LLNA EC3 values. For substances like PS-4 and PS-8, where other assays like DPRA, KeratinoSens™, h-CLAT, or mMUSST showed inconsistent predictions, the SENS-IS assay stood out. These assays' limited metabolic capacity may lead to false negatives, especially for complex substances such as pro-haptens. In contrast, the SENS-IS assay demonstrated sufficient metabolic activation, converting potential pro-haptens into skin sensitizers with precision.

This robust predictive capability underscores the reliability of the SENS-IS assay, making it an essential tool for assessing the skin sensitization potential of various chemicals. Its consistent performance is invaluable, providing accurate and reliable results for even the most challenging substances.

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Join Us in Revolutionizing Safety Testing

Join Us in Revolutionizing Safety Testing. At Immunosearch in Grasse, France, we believe in smarter, kinder science. We develop in vitro toxicology tests to keep products safe without relying on animals. Our team is dedicated to creating better solutions for cosmetics, perfumes, medical devices, and drugs. Ready to make a difference? Join us on this exciting journey.