Introduction
Exposure to chemicals may induce allergic hypersensitivity reactions in skin or respiratory tract. To minimize exposure, chemicals are routinely screened for their sensitizing potential. Proactive identification has historically been performed using animal models, but the use of animals for safety assessment of cosmetics was recently banned within EU. Today, similar trends are spreading both globally and across industry and market segments. Methods for specific identification of respiratory sensitizers are greatly underdeveloped, with no validated, or even widely used assay readily available. Thus, there is an urgent need for development of non-animal-based methods for hazard classification of respiratory sensitizing chemicals.
GARD– Genomic Allergen Rapid Detection – is a state of the art technology platform for assessment of chemical sensitizers (Figure 1). It is based on a dendritic cell (DC)-like cell line, thus mimicking the cell type involved in the initiation of the response leading to sensitization. Following test chemical exposure, induced transcriptional changes are measured to study the activation state of the cells. These changes are associated with the immunological decision-making role of DCs in vivo and constitutes of e.g. up-regulation of co-stimulatory molecules, induction of cellular and oxidative stress pathways and an altered phenotype associated with recognition of xenobiotic matter. By using state-of-the-art gene expression technologies, high informational content data is generated, that allows the user to get a holistic view of the cellular response induced by the test substance.
Conclusion
GARDair is a novel assay for assessment of respiratory sensitizers. It is an adaptation of the GARD platform, utilizing gene expression analysis of predictive biomarker signatures and state-of-the-art data analysis methodology. GARDair has been proven functional and is currently progressing towards industrial implementation and regulatory acceptance with financial support from the EU programme Horizon 2020. This progress includes scientific verification of results, assay optimization, assay
transfer and formal validation by a blinded ring trial.
SenzaGen will participate in the Vator Securities Unicorn Summit, which takes place today, October 10, at Medicon Village in Lund. Anki Malmborg Hager will present Senzagen´s developments and accelerated efforts towards further strengthening the commercial organization and the global presence of SenzaGen’s platform GARD®, a group of tests for animal-free safety testing.
Unicorn Summit is a capital market day organized by Vator Securities to bring together some of the most innovative and fast-growing Swedish life science companies with investors. More information about Vator Securities www.vatorsecurities.se
Dr Henrik Johansson will hold a presentation on Thursday, October 4 at 09:25, on the topic “Predictive Respiratory Toxicology with the GARD In-Vitro Testing Platform”. Come and get the latest updates, meet us and all the experts and stakeholders there!
Don’t miss the interesting article in Chemical Risk Manager in Chemical Watch, written by Dr. Emma Davies, with the title; Skin sensitization integrated testing strategies need rethink, expert suggests.
Emma Davies is interviewing the UK academic Dr. David Roberts after his publication of an article in Regulatory Toxicology and Pharmacology in July where he is discussing the relevance of Integrated Testing Strategy (ITS) for skin sensitization testing as well as he is presenting data on the performance of the GARDskin test method compared to the OECD -tests.
In short, David Roberts from Liverpool John Moores University questions the science behind integrated testing strategies (ITS) for combining in vitro test methods to predict skin sensitisation, as required by REACH. Instead, Roberts suggests, ”… that the genomic allergen rapid detection (GARD) assay for skin sensitisation may outperform other OECD validated test methods, either alone or in combination.”
Dr. David Roberts will present his data and the research behind the article at the EUSAAT meeting 23-26 September in Linz, and at the ESTIV conference 15-18 October in Berlin
Read the article here (requires subscription to Chemical Watch):
https://chemicalwatch.com/crmhub/70359/skin-sensitisation-integrated-testing-strategies-need-rethink-expert-suggests
Inspelning från telefonkonferens (19 september, 2018) gällande ECVAMs utvärdering av GARDskin flyttad till extra möte i den vetenskapliga kommittén under våren 2019, på svenska.
Recording from telephone conference (September 19, 2018) regarding ECVAM evaluation of GARDskin rescheduled to an extra scientific committee meeting in spring 2019, in Swedish.
Nedan finner du även transkript från telefonkonferensen, på svenska.
Below you will find a transcript from the telephone conference, in Swedish.
SenzaGen’s CEO Anki Malmborg Hager is invited to participate and to speak at EIC Innovators’ Summit in Berlin on September 10, 2018. Anki has been selected to share her inspiring story and success as a female entrepreneur to raise awareness of Europe’s economic power of women investors and entrepreneurs. Don’t miss the workshop “Women entrepreneurs cooking up innovation” on Monday, September 10, at 4.30 PM at STATION Berlin.
Conclusion
This case study demonstrates the broadening of the applicability domain of the GARD assay when assessing UVCBs.
Abstract
In this study, four test items were evaluated. All the test items were “Unknown or Variable composition, Complex reaction products and Biological materials” materials (UVCBs), which were provided by Lubrizol and selected based on existing in vivo data (internal Lubrizol data). Skin sensitizing hazard was assessed using the GARDskin assay, and the GARDpotency assay for further subcategorized the sensitizers into strong 1 A) or weak 1 B) sensitizers according to GHS/CLP classification. The GARDskin predictions for test items 1, 2, 3 and the GARDpotency classifications for test item 2 and 3 were consistent with the in vivo data, whereas test item 4 showed inconsistency between the in vitro and in vivo methods. These results indicate the importance of screening a panel of different vehicles or mixtures thereof, in order to choose the appropriate solvent For one of the Test items, the DMSO extraction procedure generates a negative prediction while the experimental vehicle mixture, Glycerol and DMF, classifies the chemical as a skin sensitizer This case study demonstrates the broadening in applicability domain of the GARDassays when assessing UVCBs.
SenzaGen is proud to be hosting the event Understanding Biocompatibility of Medical Devices on October 2, in Lund, in cooperation with the Medicon Valley Medtech Network.
The regulatory framework of the medical device industry is going through major changes and the complexity of the process is increasing due to new requirements and standards. All medical devices that come into physical contact with patients must be assessed for allergy. Therefore, manufacturers must conduct biological safety evaluations before market approval.
Date: 2nd of October, 2018
Time: 17.00- 20.00
Host: SenzaGen AB
Venue: Auditorium, Medicon Village, Lund
Program
Moderator: Rose-Marie Jenvert, Project Manager, SenzaGen AB
| 17.00-17.30 | Registration, networking and a bite to eat – meet the fellow participants |
| 17.30-17.35 | Welcome Petter Hartman, CEO, Medicon Valley Alliance Kerstin Jakobsson, CEO, Medicon Village Innovation |
| 17.35-17.40 | Sponsor of the event Peter Borg Gaarde, Partner & European Patent Attorney, HØIBERG P/S |
| 17.40-18.15 | Introduction to Biocompatibility and ISO 10993 Monica Grekula, Business Area and Team Manager Toxicologist, Symbioteq |
| 18.15-18.35 | Chemical characterization according to ISO 10993-18 Carsten Senholt, Principal Toxicologist, SAXOCON |
| 18.35-18.55 | Industry perspective on hemocompatibility testing according to ISO 10993-4 Barbara Musi, Principal Research Scientist Toxicology & Biocompatibility, Baxter |
| 18.55-19.25 | Case study: Medical Device Biocompatibility Testing Helge Gehrke, Head of in vitro Pharmacology and Toxicology, Eurofins Biopharma Product Testing Munich |
| 19.25-19.30 | Presentation of Swiss Medtech Delegation Gustav Henriksson, Head of Trade Section, trade Point Nordics, Embassy of Switzerland in Sweden |
| 19.30 | Wrap up Rose-Marie Jenvert, Project Manager, SenzaGen AB |
| 19.30-20.00 | Networking and a light snack |
Deadline for registration is 25h of September, 2018.
Jenvert RM, Larne O, Torstensdotter MattssonU. I., Johansson H, SenzaGen, Lund, Sweden
Introduction
The Genomic Allergen Rapid Detection (GARD) assay is a state of the art in vitro assay developed for the assessment of skin sensitizers. It is based on gene expression analysis of SenzaCells, a human myeloid cell line, after stimulation by the test item.
During the development of the GARD platform, two solvents were used; DMSO (0.1%) and Water. To increase the applicability domain of GARD® and the solubility of certain test items, for e.g. Medical Device extracts and UVCBs, we here show a broader range of solvents compatible with GARD.
Conclusions
Here, we show that the GARD® platform is compatible with the following solvents:
• Acetone
• Ethanol
• Glycerol
• Super refined olive oil
• DMF
• DMSO
• Water
• Isopropanol
