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From genome-wide arrays to tailor-made biomarker readout – Progress towards routine analysis of skin sensitizing chemicals with GARD.

Toxicol In Vitro. 2016 Dec;37:178-188. doi: 10.1016/j.tiv.2016.09.013. Epub 2016 Sep 13.

Forreryd A., Zeller K., Lindberg T., Johansson H., Lindstedt M

Abstract

Allergic contact dermatitis (ACD) initiated by chemical sensitizers is an important public health concern. To prevent ACD, it is important to identify chemical allergens to limit the use of such compounds in various products. EU legislations, as well as increased mechanistic knowledge of skin sensitization have promoted development of non-animal based approaches for hazard classification of chemicals. GARD is an in vitro testing strategy based on measurements of a genomic biomarker signature. However, current GARD protocols are optimized for identification of predictive biomarker signatures, and not suitable for standardized screening. This study describes improvements to GARD to progress from biomarker discovery into a reliable and cost-effective assay for routine testing. Gene expression measurements were transferred to NanoString nCounter platform, normalization strategy was adjusted to fit serial arrival of testing substances, and a novel strategy to correct batch variations was presented. When challenging GARD with 29 compounds, sensitivity, specificity and accuracy could be estimated to 94%, 83% and 90%, respectively. In conclusion, we present a GARD workflow with improved sample capacity, retained predictive performance, and in a format adapted to standardized screening. We propose that GARD is ready to be considered as part of an integrated testing strategy for skin sensitization.

KEYWORDS:

GARD; In vitro assay; Predictive genomic biomarker signature; Skin sensitization

Link to articel on line

SenzaGen nominated for Guldråttan -the Golden Rat

SenzaGen has been nominated for the honorable price “Guldråttan” -the Golden Rat, a prize awarded by Djurens Rätt (the Animal Rights) to companies that make exceptional contribution to animal wellfare.

SenzaGen is able to greatly reduce animal use with their animal free allergy tests for cosmetic ingredients, raw material production and the pharmaceutical industries. With the company’s test GARD, which is performed in vitro, the number of animals used for testing in these industries can be heavily reduced and now that SenzaGen is expanding globally, the impact can be even greater.

“Guldråttan is Sweden’s finest animal rights prize and awarded since 1987 by Djurens Rätt to a person or persons who have made an exceptional contribution during the year to animal well fare” Djurens Rätt says ontheir site.

It is now possible to vote on who should be awarded Guldråttan 2016. Voting will run until April 10 and the winner will be presented at Djurens Rätts National Conference in Stockholm on 14-15 May.

Participate and vote at http://www.djurensratt.se/guldrattan2016 (in Swedish) Link no longer available

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.