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senzagen gard session

SenzaGen is presenting at hosted sessions at Society of Toxicology 56th Annual Meeting in Baltimore March 12-16, 2017

Lund University Scientist Andy Forreryd and SenzaGen CEO Anki Malmborg Hager will give a presentatios about the GARD assay at exhibitor hosted sessions at the Society of Toxicology 56th Annual Meeting in Baltimore, on the 13th and 14th of March.

The meeting promises more than 150 scientific sessions, approximately 350 ToxExpo exhibitors offering you the latest information on services and technology, thousands of abstract presentations, continuing education courses, awards presentations, receptions, career guidance and support, and more.

Presentations details

– Replacement of Animal Testing for CLP/GHS Classification of Skin Sensitizers is now possible using a Modified Genomic GARDskin [OECD TGP 4.106] Assay
SenzaGen presents the latest development towards reliable potency classification of chemicals according to CLP 1A and 1B, taking both LLNA and Human potency data in consideration. The assay is based on GARDskin and utilizes a refined gene expression signature developed specifically for potency categorization with high predictability.

Date: 3/13 Time: 13:30 -14:30  Room: 338

– Advantages with Genome Testing Opening up the Landscape for New Application Possibilities for Sensitization Testing using SenzaGen’s Genomic GARD Assay
SenzaGen’s GARD assay is based on expression analysis of predictive genomic biomarker signatures. Prediction calls of test substances are generated by computational methods based on machine learning. SenzaGen presents their experience in skin and respiratory sensitization testing, working with challenging compounds and mixtures, active substances, potency classification and NOEL interpretation.

Date: 3/14 Time: 13:30-14:30  Room: 338

These session are Exhibitor-Hosted Session. Although not an official part of the SOT Annual Meeting scientific program, its presentation is permitted by the Society.

Attendees are welcomed from researcher community, industry, manufacturers, regulatory agencies, consultants, CROs and every one interested in safety testing of chemical compounds.

Evaluation of the GARD assay in a blind Cosmetics Europe study

ALTEX Online first published February 17, 2017 https://doi.org/10.14573/altex.1701121

Johansson H., Gradin R., Forreryd A., Agemark M., Zeller K., Johansson A., Larne O., van Vliet E.,  Borrebaeck C., Lindstedt M.,

Summary

Chemical hypersensitivity is an immunological response towards foreign substances, commonly referred to as sensitizers, which gives rise primarily to the clinical symptoms known as allergic contact dermatitis. For the purpose of mitigating risks associated with consumer products, chemicals are screened for sensitizing effects. Historically, such predictive screenings have been performed using animal models. However, due to industrial and regulatory demand, animal models for the purpose of sensitization assessment are being replaced by animalfree testing methods, a global trend that is spreading across industries and market segments. To meet this demand, the Genomic Allergen Rapid Detection (GARD) assay was developed. GARD is a novel, cell-based assay that utilizes the innate recognition of xenobiotic substances by dendritic cells, as measured by a multivariate readout of genomic biomarkers. Following cellular stimulation, chemicals are classified as sensitizers or non-sensitizers based on induced transcriptional profiles. Recently, a number of animal-free methods were comparatively evaluated by Cosmetic Europe, using a coherent and blinded test panel of reference chemicals with human and local lymph node assay data, comprising a wide range of sensitizers and non-sensitizers. In this paper, the outcome of the GARD assay is presented. It was demonstrated that GARD is a highly functional assay with a predictive performance of 83% in this Cosmetics Europe dataset. The average accumulated predictive accuracy of GARD across independent datasets was 86%, for skin sensitization hazard. Keywords: GARD, sensitization, in vitro, predictive accuracy, alternative methods

Link to article e-pub ahead of print

 

Next generation skin sensitisation testing.

Personal Care Magazine Europe, sept 2016

Malmborg Hager A., Johansson H., Lindstedt M., Borrebaeck CA.

 

DNA is the software that predicts human phenotypes. Genomics utilises DNA as such a piece of software, which in several recent applications has been demonstrated to be able to predict a number of biological features, enabling anything from face recognition to vaccine development. The tremendous information content, harboured in the DNA, should be harnessed in tests of cosmetic ingredients and formulations, to get a complete insight into what is happening in the body when these types of products are applied to the human skin. This type of complex information gives a holistic view of a human condition that many of us are familiar with, such as e.g. allergic contact dermatitis, and has the potential not only to classify chemicals used in cosmetics but also to determine the magnitude to which a
chemical affects the human body (the potency).

This distinguishes genomics from most other test principles, where in many cases only one or two markers are being
monitored, such as DC activation markers (CD86, CD54), genes involved in cytoprotective responses to oxidative stress or electrophilic compounds (Nrf2, Keap1), or proinflammatory cytokines, (e.g. IL18).

Next generation skin sensitisation testing. PC Magazine, Sept 2016. Malmborg Hager A., Johansson H., Lindstedt M., Borrebaeck CA.

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 member of the board

Ian Kimber joins the board of SenzaGen AB

SenzaGen AB, a diagnostic spin-off company from Lund University, is proud to announce that Prof. Ian Kimber will join the Board of Directors.

SenzaGen AB is a diagnostic company working to replace animal testing for sensitization predictions.

Prof Ian Kimber is currently Professor of Toxicology and Associate Dean for Business Development in the Faculty of Life Sciences at the University of Manchester. He has broad research interests at the interface between toxicology and immunology, with a particular focus on allergy and inflammation.  Professor Kimber holds, and has held, a variety of positions on national and international expert and scientific advisory committees. Currently these include the following:  Member UK Medicines and Healthcare products Regulatory Agency (MHRA) Committee for Safety of Devices, Programme Advisor Food Standards Agency Food Allergy and Intolerance Research Programme, and member MRC Translational Research Group. Professor Kimber was previously President of the British Toxicology Society (BTS) (2012-2014), and Chairman of the Board of the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) (2008-2013).  

“I am delighted to be joining the Board of SenzaGen at such an exciting period of growth. Since our initial studies that led to the development and ultimate validation of the Local Lymph Node Assay I have maintained a keen interest in chemical allergy and in the development of novel approaches for improved hazard identification and risk assessment. In this respect harnessing fully the opportunities afforded by developments in the biomedical sciences is critical, and the work of SenzaGen in exploiting a genomic approach to pathway analysis and risk assessment is at the cutting edge of new developments”, says Prof Kimber.

Ian Kimber has published over 600 research papers, review articles and book chapters, and serves currently on the editorial boards of toxicology, immunology, dermatology and pathology journals.

“We are very happy to have Prof Kimber on board in SenzaGen”, since he is one of the forerunners in sensitization testing, says Prof Carl Borrebaeck, “his knowledge and interest in the field of allergy and replacement of animal testing with new technologies is very important to us. We value his participation in developing the next generation tests.”

Hanna Frykman

Hanna Frykman new Market Coordinator at SenzaGen

SenzaGen continues its expansion and is setting up a sales and marketing organisation. In this process SenzaGen recruits Hanna Frykman as a marketing coordinator.

Most recently, Hanna comes from the Royal Academy of Sciences, where she worked as an information coordinator and scientific secretary of an EU project. Hanna has experience as communicator and project manager, and has been working with startup companies. She is one of the developers of the cultural business project Thomanders Jul in Lund.

– It is extremely exciting to be working with a company in this early stage and to build up the business from scratch, says Hanna Frykman.

Hanna begins in SenzaGen in March 2015 and will focus on developing graphical profile and work with sales and marketing at SenzaGen.

– The combination of science and business thinking and her ability to build up network was been instrumental in the recruitment of Hanna. I very much look forward to working together with Hanna, says Anki Malmborg Hager, CEO of SenzaGen

senzagen maria agemark

Maria Agemark new quality manager at SenzaGen

SenzaGen is in an expansive phase and is building up its team with new personnel. Maria Agemark has been recruited as quality manager and was previously working at the Department Immunotechnology at LTH . Maria has a PhD in biochemistry, where she conducted research on the Aquaporins in humans and plants.

– It is going to be exciting and challenging to work in a new company that is in an exciting early phase. I know the research behind the products well and look forward to be part of the new team that SenzaGen is setting up, says Maria Agemark .

Maria starts on SenzaGen in March 2015 and will focus on building up the new lab and quality systems.

– Maria has an expertise that we need to bring the company to the next level. I very much look forward to working together with Maria, says Anki Malmborg Hager, CEO of SenzaGen.

The GARD assay for assessment of chemical skin sensitizers.

Toxicol In Vitro. 2013 Apr;27(3):1163-9. doi: 10.1016/j.tiv.2012.05.019. Epub 2012 Sep 29.

Johansson H., Albrekt A.S., Borrebaeck C.A.K., Lindstedt M

Abstract

Allergic contact dermatitis is a skin disease caused by an immunologic reaction to low molecular weight compounds, so called haptens. These substances are commonly present in products used by humans in daily life, such as in cosmetics and fragrances, as well as within chemical industry and in pharmaceuticals. The frequent usage of these compounds in different applications has led to increasing incidences of allergic contact dermatitis, which has become a substantial economic burden for society. As a consequence, chemicals are routinely tested for their ability to induce skin sensitization, using animal models such as the murine Local Lymph Node Assay. However, recent legislations regulate the use of animal models within chemical testing. Thus, there is an urgent need for in vitro alternatives to replace these assays for safety assessment of chemicals. Recently, we identified a signature of predictive genes, which are differentially regulated in the human myeloid cell-line MUTZ-3 when stimulated with sensitizing compounds compared to non-sensitizing compounds. Based on these findings, we have formulated a test strategy for assessment of sensitizing compounds, called Genomic Allergen Rapid Detection, GARD. In this paper, we present a detailed method description of how the assay should be performed.