GARD® and SenzaGen mentioned in Chemical Risk Manager, September 18, 2018

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 […]

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.”

“The failure of the ITS based on AOP logic does not mean that the AOP is wrong. What it does indicate is that the three OECD guideline assays do not truly or adequately reflect the KEs that they are assumed to model,” he says.

Further Emma writes in her article; “His analysis suggests that the genomic allergen rapid detection (GARD) assay for skin sensitisation may outperform other OECD validated test methods, either alone or in combination. A team from Lund University in Sweden developed the GARD test, which is sold by Swedish company Senzagen.”

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

 

 

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Inspelning från telefonkonferens gällande ECVAMs utvärdering av GARDskin flyttad till våren 2019

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.    

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.

 

 

SenzaGen’s CEO invited to speak at EIC INNOVATORS’ SUMMIT in Berlin, September 10

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 […]

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.

SenzaGen hosts network meeting Understanding Biocompatibility of Medical Devices, October 2, at Medicon Village in Lund

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 […]

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.

Learn more about biocompatibility, the legal framework and the new ISO 10993
– sign up for the event  here

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.

More info

Extended applicability domain with new solvent selection for the GARD platform

Jenvert RM, Larne O, TorstensdotterMattssonU. 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 […]

Jenvert RM, Larne O, TorstensdotterMattssonU. 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

Poster download

Exploration of the GARD® applicability domain – Sensitization assessment of UVCBs

U. I. Torstensdotter Mattson, C. Humfrey, O. Larne, H. Johansson, L. Sweet SenzaGen, Lund, Sweden, Lubrizol, Derbyshire, United Kingdom, Lubrizol, Ohio, United States of America Introduction The GARD – Genomic Allergen Rapid Detection – platform is a state of the art in vitro assay for assessment of chemical sensitizers. The GARD®skin assay is a powerful […]

U. I. Torstensdotter Mattson, C. Humfrey, O. Larne, H. Johansson, L. Sweet
SenzaGen, Lund, Sweden, Lubrizol, Derbyshire, United Kingdom, Lubrizol, Ohio, United States of America

Introduction
The GARD – Genomic Allergen Rapid Detection – platform is a state of the art in vitro assay for assessment of chemical sensitizers. The GARD®skin assay is a powerful tool for assessment of chemical sensitizers, with a predictive accuracy of 94%. In this study, four UVCB test items, provided by Lubrizol and selected based on existing in vivo data (internal Lubrizol data), were evaluated. Sensitizing hazard was assessed using the GARD®skin assay, and the GARD®potency assay further subcategorized the sensitizers into strong (1A) or weak (1B) sensitizers according to GHS/CLP classification. Here we show the importance of using appropriate vehicles in order to predict a correct classification of Test items.

 

Conclusion
A UVCB Test item with poor water and DMSO solubility was assessed using a mixture of vehicles with different polarity indexes (DMF and Glycerol 1:1). This experimental vehicle mixture classified the UVCB as a skin sensitizer, being consistent with the in vivo data. This case study demonstrates the broadening of the applicability domain of the GARD -assay when assessing UVCBs.

Poster dowload

The Validation of GARD®skin

Sandberg P, Johansson A, Agemark M, Gradin R, Larne O, Appelgren H, Forreryd A, Jerre A, Edwards A, Hoepflinger V, Burleson F, Gehrke H, Roggen E, Johansson H SenzaGen, Lund, Sweden, Burleson Research Technologies, Morrisville, US, Eurofins, Munich, Germany Introduction The prevalence of allergic contact dermatitis (ACD) is estimated to >20% in the western world. […]

Sandberg P, Johansson A, Agemark M, Gradin R, Larne O, Appelgren H, Forreryd A, Jerre A, Edwards A, Hoepflinger V, Burleson F, Gehrke H, Roggen E, Johansson H
SenzaGen, Lund, Sweden, Burleson Research Technologies, Morrisville, US, Eurofins, Munich, Germany

Introduction
The prevalence of allergic contact dermatitis (ACD) is estimated to >20% in the western world. Not only the individual is affected, but downstream socioeconomic effects are high. To minimize exposure, chemicals must be safety tested. Traditional testing strategies like the murine local lymph node assay (LLNA) comprise animals, but the regulatory authorities, public opinion and economic interests require animal-free models. The Genomic Allergen Rapid Detection skin (GARD®skin) is an in vitro assay addressing this need. Here, we present the results of the GARD®skin ring trial (OECD TGP 4.106) for validity of the assay. In addition, we show data for GARD®potency – a complementary assay developed to categorize identified senitizers as CLP 1A or 1B.

 

Conclusions

Transfer study
Transferability: 100%

Validation study
Reproducibility
WLR: 82 – 89%BLR: 92% (92 – 100%)
Test performance
– Accuracy: 94%
– Sensitivity: 93%
– Specificity: 96%

A blinded ring trial was performed to assess the functionality of the GARDskin assay. The data demonstrates that GARDskin is a powerful tool for assessment of chemical skin sensitizers, with a predictive accuracy of 94% and excellent reproducibility between laboratories.
In addition, we show that GARDpotency accurately assesses potency of identified sensitizers.

Poster download

Predicting skin sensitizaers with confidence-Using conformal prediction to determine applicability domain

Objective GARD – Genomic Allergen Rapid Detection – is a state of the art non-animal based technology platform for classification of skin sensitizing chemicals. The assay has proven to be reliable and highly accurate for identification of skin sensitizing chemicals, and consistently reports predictive performances > 90% across external test sets. The aim of the […]

Objective
GARD – Genomic Allergen Rapid Detection – is a state of the art non-animal based technology platform for classification of skin sensitizing chemicals. The assay has proven to be reliable and highly accurate for identification of skin sensitizing chemicals, and consistently reports predictive performances > 90% across external test sets. The aim of the current project is to complement assessments of average model performance with an estimate of uncertainty involved in each individual prediction, thus allowing for classification of skin sensitizers with confidence.

Results
An Internal validation procedure was initially performed on samples in the GARD training set (n=38) using the strategy described in Fig. 3A. Results from this exercise is summarized in Fig. 4A. Conformal prediction by definition allows the user to determine a reasonable and acceptable significance level to guarantee a maximum error rate in predictions. The significance level was set to 15%, i.e. the model was allowed to make a maximum of 15% errors. Performance of the conformal predictor was measured by validity and efficiency. A model was valid if the number of prediction errors did not exceed the significance level, while efficiency corresponded to the percentage of single class predictions. Internal validation of the training data resulted in a valid and highly effective model (92% single classifications, 1 empty, 2 both), indicating that the ambitious significance level was at a reasonable level for the GARD® assay. Following internal validation, samples in a large external test set (n =70) was classified within the CP framework as described in Fig. 3B, which resulted in generation of a valid and highly efficient model (99% single classifications, 0 empty, 1 both) (Fig.4B). Additional data on model performance is illustrated in Table 1.

Poster download

The use of GARDskin for sensitization evaluation of cosmetic ingredients and ‘real-life’ mixtures

Renato Ivan de Ávila, Tim Lindbergh, Malin Lindstedt and Marize Campos Valadares Lab. of Education and Research in Pharmacology and Cellular Toxicology, Faculty of Pharmacy, Federal University of Goiás, Goiânia, Goiás, Brazil. Department of Immunotechnology, Medicon Village, Lund University, Lund, Sweden.   Introduction Genomic fingerprints in dendritic cells after chemical exposure is a recent strategy […]

Renato Ivan de Ávila, Tim Lindbergh, Malin Lindstedt and Marize Campos Valadares
Lab. of Education and Research in Pharmacology and Cellular Toxicology, Faculty of Pharmacy, Federal University of Goiás, Goiânia, Goiás, Brazil.
Department of Immunotechnology, Medicon Village, Lund University, Lund, Sweden.

 

Introduction
Genomic fingerprints in dendritic cells after chemical exposure is a recent strategy in in vitro techniques for skin sensitization hazard. Within this perspective, Genomic Allergen Rapid Detection (GARDskinTM), an assay based on a support vector machine (SVM) model, was developed for identifying contact allergens using a myeloid cell line as a surrogate for dendritic cells. Predictive system behind the GARDskin™ consists on the transcriptional quantitative analysis of 200 genes, referred as the GARDskin™ prediction signature. Mechanistically, GARDskin™ is linked to key event 3 “Activation of DCs”, as defined by the Adverse Outcome Pathways for skin sensitization published in 2012 by OECD (https://read.oecd-ilibrary.org/environment/the-adverse-outcome-pathway-for-skin-sensitisation-initiated-by-covalent-binding-to-proteins_9789264221444-en#page1)

 

Resluts
Information declared on the label and lawsone and PDD levels found in ten commercial henna-based hair coloring cosmetics are show in Table 1. Since all products analyzed were declared as henna cosmetics by the manufactures, the presence of LAW, the main active phytochemical of henna, was then expected in all samples. However, HPLC analysis showed no LAW level in the product nº 2, suggesting falsification. Furthermore, the presence of PPD was declared on the products nº 2 and 8 only by the manufactures. However, this substance was detected in all products, suggesting undisclosed adulteration.

Poster:
The use of GARDskin for sensitization evaluation of cosmetic ingredients and ‘real-life’ mixtures

SenzaGen co-hosting international workshop on Skin Sensitization in Brazil 21st August 2018

SenzaGen is co-hosting a workshop on skin sensitization at the Federal University of Goiás, Faculty of Pharmacy, Goiás. The workshop, relevant both for Industry and Academy, is a collaboration between SenzaGen AB – Laboratório de Farmacologia e Toxicologia Celular- FarmaTec-FF on new tools for skin sensitization testing. During the workshop you will have the chance […]

SenzaGen is co-hosting a workshop on skin sensitization at the Federal University of Goiás, Faculty of Pharmacy, Goiás.

The workshop, relevant both for Industry and Academy, is a collaboration between SenzaGen AB – Laboratório de Farmacologia e Toxicologia Celular- FarmaTec-FF on new tools for skin sensitization testing. During the workshop you will have the chance to get acquainted with the GARD platform, learn about hands-on usage and learn how the GARD method was developed as well as how it can help you to test your product in a safe and secure way. Further, the workshop will give you information on the current situation for alternative methods in Brazil, the skin sensitization AOP and the regulatory framework.

For more information and invitation read the Faculty of Pharmacy webpage