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. 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

SenzaGen receives patent protection for GARDskin™ in China

The recently granted Chinese patent covers the analytical methods and genetic signatures that form the basis of SenzaGen’s GARDskin™ technology. The patent is valid until October 2031.

“China is a potentially important future market for us, and patent protection in China is another confirmation of our technology’s merits and a new milestone in establishing our unique GARDskin™ test method as a global industry standard. This complements European patent protection and further strengthens our potential in the global market of in vitro tests,” says SenzaGen CEO, Anki Malmborg Hager.

A vital part of SenzaGen’s business development is relations with contract laboratories, industry, government agencies and NGOs concerned with alternative testing methods. The market for in vitro methods is growing rapidly, although experiments on animals are still permitted for allergy tests in some parts of the world. Asia is a huge market and is growing fast, and it is therefore essential for SenzaGen to prepare the way for a future introduction of its tests there.

The announcement from the Chinese Patent Office relates to Chinese Patent No. CN 103429756 B entitled: “Analytical methods and arrays for use in the identification of agents inducing sensitization in human skin”. Corresponding patent applications are currently being processed by the patent authorities in Brazil, Canada, Hong Kong, India, South Korea and the United States. 

For more information, please contact:
Anki Malmborg Hager, CEO, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telephone: +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 over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. 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 http://www.senzagen.com.

The information was submitted for publication, through the contact person set out above on July 11th 2018 at 08:50

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com.

Attached file

SenzaGen’s final validation report for the animal-free allergy test GARDpotency™ has been submitted to the regulatory authorities

GARDpotency™ is based on the same biological platform as GARDskin™ and both tests are expected to be approved and recommended at the same time. Together with GARDpotency™, which complements GARDskin™, SenzaGen’s allergy test will be unique on the market, as it is the only test that offers animal-free tests of chemicals in line with the EU’s CLP classification. The CLP classification follows the Global Harmonized System, GHS, developed by the UN to create common criteria for the classification and labelling of chemicals.

The EU Chemicals Agency ECHA, which regulates chemical use based on the REACH Regulation, requires that chemicals that may induce sensitivity (sensitization) must be potency-classified according to CLP. This has so far only been possible with a so-called LLNA (Local Lymph Node Assay) evaluation, which is an in vivo test using animals. SenzaGen’s GARD™ test platform is based on human cells in vitro and genomic biomarkers, constantly delivering better accuracy than animal tests.

“Potency is extremely difficult to measure. We are therefore very happy to be able to report these results. In view of the impressive validation results for GARDpotency™, we look forward to receiving the authorities’ response regarding GARDskin™ and GARDpotency™ in 2019. As a consequence of these good results, we are planning to communicate sales targets for the coming years during the second half of this year. A positive response would make our allergy test the first animal-free test that can be used for classification in accordance with CLP, the EU’s standard,” says Anki Malmborg Hager, CEO of Senzagen.

The results from the validation report will be presented at forthcoming scientific conferences.

For more information, please contact:
Anki Malmborg Hager, CEO, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telephone: +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 over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. 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 http://www.senzagen.com.

The information was submitted for publication, through the contact person set out above on the 6 July 2018 at 08:50

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com.

Attached file

Conclusive data on predictive performance of GARD™ in highly regarded scientific journal

SenzaGen announces today that research on the conformal prediction of the GARD™ assay has been published in the distinguished peer reviewed journal Toxicology in Vitro. The research presented in the publication proves that, as the first in vitro model for prediction of the skin sensitizing potential of chemicals, GARD™ is now capable of providing a statistically valid measure of uncertainty for each individual prediction, thus allowing for classification of skin sensitizers with confidence. Consequently, GARD™ can meet the growing needs of high safety skin sensitization testing and particularly since there is now proof that all chemical reactivity domains, as well as pre- and pro-haptens are within GARD’s applicability domain. 

In the publication, Predicting skin sensitizers with confidence — Using conformal prediction to determine applicability domain of GARD™, a research group from Lund University, Swetox and SenzaGen reports its successful work on implementing a mathematical framework based on conformal prediction into GARD™ for the purpose of defining the applicability domain of the assay, something often neglected by test developers. Investigation of historical data within the framework demonstrates that all hitherto tested chemical reactivity domains, as well as pre- and pro-haptens are within the applicability domain of GARD, and can be predicted with a high degree of confidence. The results of this research demonstrate that the multivariate genomic biomarker signature, the unique technology of GARD makes it applicable across various chemical reactivity domains.

The mathematical framework in this implementation defines the applicability domain in terms of similarity to the samples used for model development and is capable of providing a statistically valid measure of uncertainty associated with each prediction. Furthermore, it also delivers a warning if a specific test sample is outside the region where the model is capable of generating a reliable prediction. Similar to the field of QSAR modelling, this information should be a minimal requirement for a successful validation also of in vitro models.

As the first in vitro model for prediction of skin sensitizing potential of chemicals, GARD™ is now capable of providing a statistically valid measure of uncertainty for each individual prediction, thus allowing for classification of skin sensitizers with even higher confidence. These scientific findings will benefit the chemical industry by providing better guidance of what test to use for different substances in different chemical domains and demonstrates the even broader applicability of GARD.

Full article:  Predicting skin sensitizers with confidence — Using conformal prediction to determine applicability domain of GARD Forreryd A., Norinder U., Lindberg T., Lindstedt M.  
https://www.sciencedirect.com/science/article/pii/S0887233318300237?via%3Dihub


For more information:
Anki Malmborg Hager, CEO, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telephone: +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 over 90% reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75%. 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

News post as pdf

Predicting skin sensitizers with confidence – Using conformal prediction to determine applicability domain of GARD

Toxicol In Vitro.  Jan 30 2018,  [Epub ahead of print];48:179-187. doi: 10.1016/j.tiv.2018.01.021.

Andy Forreryd, Ulf Norinder, Tim Lindberg, Malin Lindstedt.

Abstract

GARD – Genomic Allergen Rapid Detection is a cell based alternative to animal testing for identification of skin sensitizers. The assay is based on a biomarker signature comprising 200 genes measured in an in vitro model of dendritic cells following chemical stimulations, and consistently reports predictive performances ~90% for classification of external test sets. Within the field of in vitro skin sensitization testing, definition of applicability domain is often neglected by test developers, and assays are often considered applicable across the entire chemical space. This study complements previous assessments of model performance with an estimate of confidence in individual classifications, as well as a statistically valid determination of the applicability domain for the GARD assay. Conformal prediction was implemented into current GARD protocols, and a large external test dataset (n = 70) was classified at a confidence level of 85%, to generate a valid model with a balanced accuracy of 88%, with none of the tested chemical reactivity domains identified as outside the applicability domain of the assay. In conclusion, results presented in this study complement previously reported predictive performances of GARD with a statistically valid assessment of uncertainty in each individual prediction, thus allowing for classification of skin sensitizers with confidence.

KEYWORDS:
Applicability domain; Conformal prediction; GARD; In vitro assay; Skin sensitization

PMID: 29374571     DOI: 10.1016/j.tiv.2018.01.021

Article on line

SenzaGen signs its first global licensing agreement with Eurofins BioPharma Product Testing Munich

Lund, 15 February, 2018 – SenzaGen (Nasdaq First North: SENZA) announces today that the company has signed a global licensing agreement with the leading contract research organization Eurofins BioPharma Product Testing Munich (Eurofins BPT Munich), to market the GARD™ test to its clients. GARD™ is a genome-based test, with higher accuracy than other available test methods that gives the customers important safety information whether chemical substances are at risk of causing allergies in humans.

Eurofins BioPharma Product Testing is the largest network of harmonized bio/pharmaceutical GMP/GLP product testing laboratories worldwide with 30 facilities all over the world, providing comprehensive laboratory services for the world’s major pharmaceutical, biopharmaceutical and medical device companies. The Munich subsidiary of Eurofins BioPharma Product Testing was part of the successful ring trial in the validation of GARDskin™, which was completed in the autumn of 2017.

Under the terms of the agreement, Eurofins BPT Munich will immediately include GARDskin™ and the add on test GARDpotency™ as a leading diagnostic tool in its chemical safety testing services to clients in the cosmetic, chemical and pharmaceutical industries worldwide.

“This new license agreement with such a major and strong partner provides an important stepping stone in the global marketing of GARD and it is also a hallmark of the high quality and relevance of GARD. We are very pleased to sign this important deal, in particular since Eurofins BPT Munich is a leading player in chemical safety testing, with a pronounced mission to contribute to global health and safety,” says SenzaGen’s CEO Anki Malmborg Hager.

GARDskin has the potential to meet the increasing demands in the cosmetics, chemicals and pharmaceutical industries for reliable, animal-free testing methods to assess the allergy-inducing properties of chemical substances. The test is in the process of obtaining regulatory approval and inclusion in international test guidelines.

 

For more information:
Anki Malmborg Hager, CEO, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telephone: +46 768 284822

 

About Eurofins BioPharma Product Testing, Munich
Eurofins BPT Munich is part of the world’s largest network of biopharmaceutical GMP/GLP testing laboratories. With more than 30 years of experience Eurofins BPT Munich provides a comprehensive testing portfolio to its clients in the fields of biopharma product testing, medical device testing and human safety testing.

Eurofins BPT Munich is a leader in in vitro and ex vivo safety testing. By offering its clients a comprehensive set of alternative in vitro and ex vivo test methods Eurofins BPT Munich provides the full service toxicological evaluation under GLP.

Eurofins BPT Munich offers clients the flexibility to choose from its fee-for-service, FTE, and the award-winning Professional Scientific Services® (PSS) service models in order to meet clients’ specific project needs.
For more information please visit:     www.eurofins.com/human-safety-testing

 

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 up to 90% reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75%. 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

 

This information is information that SenzaGen is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out above on the 15 February, 2018 at 10:30.

 SenzaGen AB are listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit www.senzagen.com

 

Press release as pdf

SenzaGen’s final validation report of GARDskin™ submitted to regulatory authorities – reveals highest test prediction accuracy in the field

Lund, January 12, 2018 – SenzaGen (Nasdaq First North: SENZA) announces today that the company has submitted the final report for the validation of GARDskin™ to the regulatory authorities. Global regulatory approval and recommendation by ECVAM and OECD on the use of GARDskin is expected in April 2019. The final result presented in the report shows an unprecedented over all prediction accuracy of 93,8% in determining whether chemical substances are at risk of causing allergies. This proves that GARDskin™ outperforms all current available validated methods.

 

The analysis of the data has been performed by an independent validation statistics consultant, according to the regulatory requirements. This analysis is the base for the official report now sent in to ECVAM. The data shows that the mean accuracy from all three independent laboratories (Eurofins BioPharma Product Testing in Germany, Burleson’s Research Technologies in the United States and SenzaGen’s own laboratory in Lund) is very high, reaching an accuracy of 93,8%.

The validation has included a large number of coded chemicals unknown to the validation laboratories, to enable the blinded testing demanded in this process. All laboratory results have been provided in a blinded manner to an external validating statistics consultant, who has now decoded the identity of the chemicals to compare the GARD classification performed at each lab, and analysed the prediction accuracy of GARD in classifying compounds as non-sensitizers or sensitizers. The validation report also includes data on the robustness of the test platform and its transferability.

The results in this report constitutes the basis for the evaluation of SenzaGen’s tests in the ECVAM Scientific Committee and within the OECD for regulatory approval and Test Guideline recommendation on the use of GARDskin. The regulatory decision from OECD is expected in April 2019. GARDpotency™, which is based on the same biological platform, is being validated in parallel with GARDskin™, and is thus expected to be approved and recommended at the same time.

“These excellent validation results underpin the potential for GARD testing to become a game changer in in vitro allergy testing. We have long been aware of its high performance, and the validation now also provided by independent laboratories is of course very satisfying. Importantly, the validation has highlighted the simplicity of assay transfers to other labs. This adds to the confidence of further laboratories around the world to set up our unique assay,” says Anki Malmborg Hager, CEO of SenzaGen.

A comprehensive report of the results will be presented at the Society of Toxicology’s 57th Annual Meeting 11-15 March in San Antonio, US.

 

For more information:
Anki Malmborg Hager, CEO, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telephone: +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 up to 90% reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75%. 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 

The information was provided by the contact person for publication on 12 January 2018 at 08:45.

SenzaGen AB are listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit www.senzagen.com

Positive research results for SenzaGen’s GARDpotency test published in leading scientific journal

SenzaGen announces today that a scientific evaluation of GARDpotency shows that the test reveals with high accuracy whether chemical substances are allergenic and how strong the allergic effect of the chemical is. The results have been published in the prestigious scientific journal Altex. GARDpotency is a gene-based test which is carried out in vitro, thus eliminating the need for animal testing.

The recently published scientific evaluation has been conducted by a research group at Lund University led by Malin Lindstedt, professor and senior lecturer at the Department of Immunotechnology. The research group has been able to identify 52 biomarkers which, with very high accuracy, can quantify the allergenic effect of a chemical substance. GARDpotency is thus able to meet the challenges facing chemical manufacturers as the authorities tighten the requirements for allergy testing at the same time as regulating and prohibiting the use of the animal tests which are currently in use.

“The results of this scientific evaluation underline the fact that GARDpotency has the potential to revolutionize the testing of the chemicals we come into contact with in our daily lives. A significant advantage of GARDpotency is that it enables existing animal-based methods in regulatory testing to be replaced in line with the EU’s REACH regulation,” says SenzaGen CEO Anki Malmborg Hager.

The EU’s chemical substances regulation REACH places strict controls on the evaluation, registration and use of chemical substances. Since 2013 cosmetics may not be allergy tested on animals and, under the REACH regulation, animal-free methods must be used if available. One consequence of this is that chemicals classified as allergenic must also be potency-classified without the use of animal testing. SenzaGen has commenced a limited launch of GARDpotency and is now working to adapt the test method to the needs of industry and to achieve OECD validation.

The scientific report is available via this link:
http://www.altex.ch/resources/Zeller__of_170412_v2.pdf

For more information:
Anki Malmborg Hager, CEO SenzaGen
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

Press release in pdf

The GARD platform for potency assessment of skin sensitizing chemicals

ALTEX Online first published April 12, 2017, version 2 https://doi.org/10.14573/altex.1701101

Kathrin S. Zeller, Andy Forreryd, Tim Lindberg, Robin Gradin, Aakash Chawade and Malin Lindstedt,

Summary

Contact allergy induced by certain chemicals is a common health concern, and several alternative methods have been developed to fulfill the requirements of European legislation with regard to hazard assessment of potential skin sensitizers. However, validated methods, which provide information about the potency of skin sensitizers, are still lacking. The cell-based assay Genomic Allergen Rapid Detection (GARD), targeting key event 3, dendritic cell activation, of the skin sensitizer AOP, uses gene expression profiling and a machine learning approach for the prediction of chemicals as sensitizers or non-sensitizers. Based on the GARD platform, we here expanded the assay to predict three sensitizer potency classes according to the European Classification, Labelling and Packaging (CLP) Regulation, targeting categories 1A (strong), 1B (weak) and no cat (non-sensitizer). Using a random forest approach and 70 training samples, a potential biomarker signature of 52 transcripts was identified. The resulting model could predict an independent test set consisting of 18 chemicals, six from each CLP category and all previously unseen to the model, with an overall accuracy of 78%. Importantly, the model was shown to be conservative and only underestimated the class label of one chemical. Furthermore, an association of defined chemical protein reactivity with distinct biological pathways illustrates that our transcriptional approach can reveal information contributing to the understanding of underlying mechanisms in sensitization.

Link to article online

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