Inter-laboratory ring trial of the GARD™air assay for assessment of respiratory sensitizers
Andy Forreryd1, Joshua Schmidt1, Robin Gradin1, Florence Burleson, Helge Gehrke3, Henrik Johansson1.
1SenzaGen AB, Lund, Sweden. 2Burleson Research Technologies, Morrisville, NC, USA. 3Eurofins BioPharma Product Testing Munich GmbH, Planegg, Germany.
Sensitization of the respiratory tract by sensitizing chemicals may lead to severe bronchoconstriction and asthma-like symptoms with a potentially fatal outcome. However, proactive identification and characterization of respiratory sensitization hazards is currently hampered by the lack of validated or even widely used predictive assays.
The GARD™ platform utilizes exposure-induced gene expression profiles of a dendritic cell-like cell line in combination with machine learning as a basis for predictive in vitro assays for different immunotoxicity endpoints (Johansson et al., 2020). Functional evidence of the ability to accurately identify respiratory sensitizers using the GARD platform has previously been demonstrated (Forreryd et al., 2015). Here, we present GARDair, an adaptation of previous findings on a gene expression analysis platform suited for routine acquisition, based on an optimized predictive biomarker signature. Furthermore, we present the initial results of an inter-laboratory ring-trial, demonstrating the functionality, transferability and reproducibility of the assay.
Conclusion
- GARDair is a novel in vitro assay for assessment of respiratory sensitizers, based on evaluation of exposure-induced gene expression of genomic biomarkers in a Dendritic Cell-like cell and machine-learning assisted classification.
- GARDair is the first in its class to be subjected to an inter-laboratory ring trial.
- The method is highly specific, with high PPV, making it suitable for opt-out applications within product development and candidate prioritization.
