SenzaGen presenting at Vator Securities Unicorn Summit on October 10, 2018

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

SenzaGen to attend the Medicon Valley Inhalation Symposium 2018

SenzaGen will attend the 7th Medicon Valley Inhalation Symposium – Future Opportunities of Inhalation 2018, 3- 4 October at Medicon Village. A two-day symposium on New drugs, Inhalation devices, Dissolutions, Tox and Pre-Clinical testing and Regulatory updates. 

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!

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 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

 

 

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Inspelning samt transkript 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.

 

Nedan finner du även transkript från telefonkonferensen, på svenska.

Below you will find a transcript from the telephone conference, in Swedish.

Transkript/Transcript

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 cooking up innovation” on Monday, September 10, at 4.30 PM at STATION Berlin.

Exploration of the GARD applicability domain – Skin sensitization assessment of UVCBs

Poster presented at Eurotox 2018 in collaboration with Lubrizol

Download a copy

U. I.Torstensdotter Mattson1, C. Humfrey2, O. Larne1, H. Johansson1, L. Sweet3 1SenzaGen, Lund, Sweden, 2Lubrizol, Derbyshire, United Kingdom, 3Lubrizol, Ohio, United States of America

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 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 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, 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

Poster download

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

Joint poster presented at Eurotox 2018

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 and GARD™potency

Poster presented at Eurotox, 2018

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