SenzaGen hosts open webinars on Respiratory Sensitization on 4 and 5 December

In vitro testing for Respiratory Sensitizers using a genomic biomarker signature and the GARDtechnology platform

The presentations on 4 and 5 December 2018, will give insight into the latest in vitro technology for identifying respiratory sensitizers using human dendritic-like cell lines and genomics.  A thorough explanation of the GARD platform will be covered as well as its versatility and reliability for safety assessment applicable to all industries. Sensitization testing with GARD is based on functional genomics.

The presentation will cover:

  • Development of the genomic-based GARD test platform for skin sensitization hazard, potency classification, and now also respiratory sensitization.
  • Dendritic cells – why they are also relevant for respiratory sensitization.
  • Gene mapping – what genes are in the assay, and how are they relevant for sensitization.
  • How GARD can discriminate between skin and respiratory sensitization and why this is relevant.
  • Update on the development of the SenzaGen R&D pipeline including GARD for materials – testing medical devices, GARD for proteins – classification of protein sensitizers, GARD for mixtures – assessment of complex formulations and Unknown or Variable Composition UVCBs.

Next generation in vitro skin and respiratory sensitization testing using genomics with GARD

The GARD™ platform is a versatile in vitro testing strategy which currently consist of three assays targeting two toxicological endpoints: skin sensitization (GARDskin & GARDpotency) and respiratory sensitization (GARDair). These assays make use of unique genomic biomarker signatures comprising genes involved in pathways known to be immunologically relevant to the sensitization process. Supported by modern technologies for pattern recognition, the large informational content provided by this approach enable for mechanism-of-action based decisions, which becomes evident in a consistently high predictive accuracy

Don’t miss the opportunity to learn more from our researchers.

Register by clicking on any of the links below.

 

European Registration
Tue 4 Dec 2018, 15:00 CET

Americas Registration
Wed 5 Dec 2018, 13:00 EST

 

GARDair – A novel assay for assessment of chemical respiratory sensitizers based on a genomic platform

Henrik Johansson, Andy Forreryd, Robin Gradin, Angelica Johansson, Olivia Larne, Emil Aaltonen, Anders Jerre, Carl A.K. Borrebaeck and Malin Lindstedt
SenzaGen AB, Lund, Sweden. Department of Immunotechnology, Lund, Sweden.

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.

Link to poster

Prediction of chemical respiratory sensitizers using GARD

a novel in vitro assay based on a genomic biomarker signature

Henrik Johansson, Andy Forreryd, Robin Gradin, Angelica Johansson, Olivia Larne, Emil Aaltonen, Anders Jerre, Carl A.K. Borrebaeck and Malin Lindstedt
SenzaGen AB, Lund, Sweden. Department of Immunotechnology, Lund, Sweden.

 

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 implemetation with financial support from the EU programme Horizon 2020. This progress will include scientific verification of results, assay optimization, transfer and formal validation.

Poster:

Prediction of chemical respiratory sensitizers using GARD_LIVe2018

SenzaGen to present at LIVe 2018 in Nice, July 5th-6th

On July 5th-6th, SenzaGen will be an attending sponsor at LIVe 2018 (Lung In Vitro event for innovative & predictive models) in Nice, France. The meeting intends to be a unique exchange platform for scientists interested in in vitro respiratory researches, stakeholders from academia, pharma, biotech, chemical, tobacco, consumer goods, medical devices industries, CROs and regulatory agencies.

LIVe 2018 focuses on predictive in vitro lung models designed for basic research, efficacy, sensitization and toxicity testing. It aims to present the state-of-art of in vitro lung models, and to map out the route for its future development and use.

Henrik Johansson, PhD, Senior scientist at SenzaGen, will be giving a key note presentation on the abstract “How do we incorporate recent developments in Big Data analysis and Machine Learning technologies in the field of Toxicology?” on July 6th, opening the 6th event session, “Think Different”. This will be followed by a panel discussion, including Henrik Johansson, regarding “Next Horizon for in vitro lung modeling”.

SenzaGen will also be presenting a poster with the title “GARDair – A novel assay for assessment of chemical respiratory sensitizers based on a genomic platform”. The poster summarizes SenzaGen’s findings so far regarding Horizon 2020.

If you will be attending LIVe 2018 as well, please come visit SenzaGen’s booth. Hope to see you there!

Link to conference website

Link to programme

 

SenzaGen and AstraZeneca initiate technology development collaboration

SenzaGen has signed a collaboration agreement with the global biopharmaceutical  company AstraZeneca. The collaboration focuses on  testing and development of SenzaGen’s sensitization test GARDair, in order to distinguish between allergens and irritants in the respiratory tract. The goal is the validation of in vitro toxicological tests that could be applied to the discovery of new treatments for respiratory diseases without respiratory tract irritancy as a side effect.

The collaboration means that SenzaGen will use its leading technology platform GARD, with the help of AstraZeneca’s well-documented substance libraries, to develop a new genomic signature to distinguish allergens from irritants in the respiratory tract, something which is not possible today with in vitro methods. GARD examines and finds allergens in chemicals and medicines through a unique technology in accordance with the international 3Rs principle, Reduce, Replace and Refine, as an alternative to animal testing.

“During our research and drug discovery activities, it is important to be able to identify and mitigate potential toxicological issues as early as possible, to ensure our novel candidate drugs have the right safety profile for patients. This requires in vitro toxicological methods that are properly validated for their predictivity of clinical toxicity and that are compatible with integration into the drug discovery process. By combining SenzaGen’s technological expertise and our experience with inhaled compounds, we aim to develop a novel method to investigate whether novel drug-like molecules induce similar genomic signatures as known respiratory irritants. That could ultimately be applied to steer away from a potential irritancy hazard and enable the discovery of safer drugs for patients’” says Jorrit Hornberg, Director of Discovery Safety at AstraZeneca Gothenburg.

With this new agreement SenzaGen is initiating yet another important development collaboration with the pharmaceutical industry. SenzaGen’s focus is on introducing its tests into the pharmaceutical industry and on striving to demonstrate that there are safer and more accurate tests than those that use animals.

“This collaboration with AstraZeneca is a milestone for SenzaGen. It shows that leading pharmaceutical companies see the potential of next-generation testing and that this testing has considerable industrial value. Furthermore, the collaboration will provide SenzaGen with valuable knowledge and will help to refine and develop our GARD test for further commercial opportunities,”says
Anki Malmborg Hager, CEO of SenzaGen.

The research project will run for 12 to 18 months and is in collaboration with AstraZeneca Gothenburg, contributing to the EU Horizon 2020 project granted to SenzaGen for the development of in vitro respiratory sensitization test.

For more information:
Anki Malmborg Hager, CEO, SenzaGen AB
E-mail: amh@senzagen.com
Phone: 46 768 284822

About GARD
GARD is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have 90% reliability. This compares with the current predominant test method, experiments on mice, which has a reliability rating of 72%. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGen
SenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit www.senzagen.com.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Press release in pdf

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.

SenzaGen awarded EU grant of € 2,4 million in heavy competition, to develop GARDair for industry use

SenzaGen has received a grant of € 2,4 million from the EU’s research and innovation framework program Horizon 2020 to develop GARDair, the first generation test for respiratory allergies.

GARDair is the first in vitro test that can detect air-borne chemicals that cause respiratory allergies, by using a unique gene technology. This follows the international 3Rs principle, Reduce, Replace and Refine, and is the first cell-based alternative to animal testing for the respiratory tract. The grant of 2,4 million Euros means that SenzaGen can develop and refine GARDair at the same time as being able to increase the pace of commercial development and the launch of another new product line. The grant runs for 24 months.

-We are incredibly delighted and proud to be part of the EU’s investment in the future, Horizon 2020. The fact that they choose to invest in 3Rs technologies shows how important this is. It is a confirmation of the potential of our technology platform, as well as a unique business opportunity to build on our product portfolio of commercially viable tests at a significantly faster rate, says Anki Malmborg, CEO of SenzaGen.

-It is important in many different industries to be able to test the capacity of chemicals to affect the respiratory system, and today there are no tests for this. There’s a huge need for safety testing, and the grant from the EU gives us a unique opportunity together with partners from various different industries to develop the respiratory test of the future in accordance with OECD guidelines, says Henrik Johansson, Senior Scientist at SenzaGen. SenzaGen’s EU application has been coordinated by GAEU Consulting AB and received a exceptionally high score of 14,26 out of 15 in the EU evaluation, proving excellency both in the invention and in the application document.

Horizon 2020 in brief
Horizon 2020 is the EU’s framework program for research and innovation. The program is the world’s largest investment in research and innovation and has a total budget of around € 80 billion (2014-2020). The aim is to ensure the EU’s global competitiveness. For more on Horizon 2020, see: https://ec.europa.eu/programmes/horizon2020/

For more information:
Anki Malmborg Hager, CEO, SenzaGen AB
E-mail: amh@senzagen.com
Phone: +46 768 284822

About GARD
By analyzing 200 and 389 markers, depending on the test, GARD generates massive amounts of data and delivers results with 90 % prediction accuracy. This can be compared to the golden standard, animal tests on mice, that provides 72 % prediction. SenzaGen’s test also has the ability to measure potency (strength) of a substance and can thus determine the degree to which a substance is an allergen.

About SenzaGen
SenzaGen provides dermal and respiratory in vitro testing for the cosmetic, chemical and pharmaceutical industries replacing the need for animal testing. The company’s unique test GARD is based on research from the Department of Immune Technology at Lund University. SenzaGen is based at Medicon Village in Lund, Sweden.

Press release in pdf

GARD – The story

Olivia Larne, Andy Forreryd, Ann Sofie Albrekt, Carl Arne Krister Borrebaeck, Henrik Johansson, Malin Lindstedt
SenzaGen, Sweden, Lund, Department of Immunotechnology, Lund University, Sweden, Lund

 

Background

To prevent the general population for unnecessary exposure to sensitizing substances, the substances have to be safety tested. Regulatory authorities and economic interests request animal free methodology. Genomic Allergen Rapid Detection, GARD, is an in vitro test developed for the prediction of sensitizing chemicals. It is based on differential expression of disease-associated genomic biomarkers in a human myeloid dendritic cell line.
Here, we describe the development of the GARD platform and its downstream innovations.

Poster:
GARD – The Story_ESTIV 2016

GARD – the future of sensitization testing and safety assessment of chemicals using a genomic-based platform

BACKGROUND
Genomic Allergen Rapid Detection, GARD, is an in vitro test developed for the prediction of sensitizing chemicals. It is based on differential expression of disease-associated genomic biomarkers in a human myeloid dendritic cell line.
Here, we describe the development, scientific validation, applications and the current state of the GARD platform. The scientific rationale behind the use of genomic biomarker signatures are detailed, linked to the AOP in a biological context, and to advantages realized through multivariate computational prediction models in a technological context.

RESUME
The GARD assay is elastic, it can be used for several applications. Today, two are developed:

GARDskin
– Hazard identification of skin sensitizers
– Accuracy: ~90%
– Initiated ECVAM validation (OECD TGP no. 4.106)

GARDair
– Hazard identification of respiratory sensitizers
– Accuracy: ~85%

GARD–the future of sensitization testing and safety assessment of chemicals, using a genomics-based platform_Eurotox 2016_p

SenzaGen AB, a diagnostic spin-off company from Lund University, reports the launch of a new product for respiratory sensitization testing

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

“Sensitization through the lung is a growing issue and methods to predict if a chemical has a sensitization effect are limited”, says Anki Malmborg Hager, CEO in SenzaGen. Based on extensive research about the responses of the immune system in allergic reactions, SenzaGen has now launched a test that predicts the respiratory sensitization ability of chemicals based on the GARD methodology.

An international scientific article about the underlying research has been published in PLOS ONE, under the title “Prediction of Chemical Respiratory Sensitizers Using GARD, a Novel In vitro Assay Based on a Genomic Biomarker Signature”. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0118808

SenzaGen´s first product, a skin sensitization test of chemicals, is already on the market.

Press release in pdf