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SenzaGen AB, a diagnostic spin-off company from Lund University, reports the launch of a new product for respiratory sensitization testing

SenzaGen AB is a diagnostic company working to replace animal testing for sensitization predictions.

“Sensitization through the lung is a growing issue and methods to predict if a chemical has a sensitization effect are limited”, says Anki Malmborg Hager, CEO in SenzaGen. Based on extensive research about the responses of the immune system in allergic reactions, SenzaGen has now launched a test that predicts the respiratory sensitization ability of chemicals based on the GARD methodology.

An international scientific article about the underlying research has been published in PLOS ONE, under the title “Prediction of Chemical Respiratory Sensitizers Using GARD, a Novel In vitro Assay Based on a Genomic Biomarker Signature”. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0118808

SenzaGen´s first product, a skin sensitization test of chemicals, is already on the market.

A genomic biomarker signature can predict skin sensitizers using a cell-based in vitro alternative to animal tests.

BMC Genomics. 2011 Aug 8;12:399. doi: 10.1186/1471-2164-12-399.

Johansson H., Albrekt A.S., Lindstedt M., Borrebaeck C.A.K

Abstract

BACKGROUND:

Allergic contact dermatitis is an inflammatory skin disease that affects a significant proportion of the population. This disease is caused by an adverse immune response towards chemical haptens, and leads to a substantial economic burden for society. Current test of sensitizing chemicals rely on animal experimentation. New legislations on the registration and use of chemicals within pharmaceutical and cosmetic industries have stimulated significant research efforts to develop alternative, human cell-based assays for the prediction of sensitization. The aim is to replace animal experiments with in vitro tests displaying a higher predictive power.

RESULTS:

We have developed a novel cell-based assay for the prediction of sensitizing chemicals. By analyzing the transcriptome of the human cell line MUTZ-3 after 24 h stimulation, using 20 different sensitizing chemicals, 20 non-sensitizing chemicals and vehicle controls, we have identified a biomarker signature of 200 genes with potent discriminatory ability. Using a Support Vector Machine for supervised classification, the prediction performance of the assay revealed an area under the ROC curve of 0.98. In addition, categorizing the chemicals according to the LLNA assay, this gene signature could also predict sensitizing potency. The identified markers are involved in biological pathways with immunological relevant functions, which can shed light on the process of human sensitization.

CONCLUSIONS:

A gene signature predicting sensitization, using a human cell line in vitro, has been identified. This simple and robust cell-based assay has the potential to completely replace or drastically reduce the utilization of test systems based on experimental animals. Being based on human biology, the assay is proposed to be more accurate for predicting sensitization in humans, than the traditional animal-based tests.

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