All laboratory elements completed in the regulatory part of the validation process for SenzaGen’s GARDskin allergy test

Lund, 6th October, 2017. SenzaGen (Nasdaq First North: SENZA) announces today that all laboratory elements in the validation of GARDskin have been completed according to plan. After data processing and statistical analysis, the results will be compiled and reported to the international regulatory authorities ECVAM and OECD. The results of the analysis will also be published in conjunction with the submission of this report.

The purpose of this final step of the validation process is to document reproducibility in the use of GARDskin. Three laboratories (Eurofins in Germany, Burleson’s Research Technologies in the USA and Senzagen’s own laboratory) have independently carried out tests of 28 coded chemicals on three separate occasions, and this work has now been completed.

The validation element for reproducibility follows evaluations demonstrating that GARDskin can be set up in laboratories other than SenzaGen’s own (transferability). The results of these evaluations were published at the European Toxicology Conference EuroTox in Bratislava in September 2017, showing 100% transferability.

“Every step in the validation process brings us closer to our goal of establishing GARD as the new global industry standard for animal-free toxicological testing and as the natural choice for screening new drug candidates to make it possible at an early stage to weed out substances that are harmful and will not be usable as medicines,” says SenzaGen’s CEO, Anki Malmborg Hager.

After all the results from the different stages of the validation process have been compiled and reported, an assessment will take place in the ECVAM Scientific Committee and within the OECD. Regulatory approval and the OECD’s recommendations concerning the use of GARDskin are expected in April 2019. GARDpotency, which is based on the same biological platform, is to be evaluated in parallel with GARDskin, and is thus expected to be approved and recommended at the same time.

 

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 October 6 at 11:30.

SenzaGen is presenting at hosted session at the EUROTOX Congress in Bratislava

SenzaGen new Chief Scientific officer Hernik Appelgren will give a presentation on 21st century testing for skin sensitisation and updates on application of the GARD platform at The 53rd  European Congress of the European Societies of Toxicology, EUROTOX, on the 12th of Sept. SenzaGen is also Exhibiting at the congress and presenting two posters

The meeting promises scientific sessions houndreds of abstract presentations, exhibitors meetings, continuing education courses, awards presentations, receptions,  and  an exhibition area for exhibitors offering you the latest information on services and technology
Presentation details
Tuesday 12 Sep 10-11 AM | 
Memories, Hotel Sheraton
21st Century Sensitisation testing: Can one test be stand alone? Regulatory challenges and GARD applications update
.

Presented by: Henrik Appelgren, Chief Scientific Officer and regulatory expert at SenzaGen

Allergy is a growing health problem in humans. The data requirements for the assessment of sensitisation in chemical legislations have been based on animal assays, which until now have served as the golden standard. However, in vitro assays have been developed which need to be combined in order to address all key events for sensitisation to fulfil the demands in e. g., Reach. However, The Genomic Allergen Rapid Detection Skin (GARDskin) assay addresses all the key regulatory questions regarding sensitisation, including potency – How? This session we will give an update on the validation status and the different applications of GARD.

Posters
ID 668 | Session 2 | Board no P-04-02-07 | Monday, Sept 11 from 15:00
Transferability of the GARDskin assay to two independent laboratories.

ID 438 | Session 4 | Board number P-09-02-31 | Tuesday, Sept 12 from 15:00
The GARD platform for potency assessment of skin sensitizing chemicals

Skin Sensitization: Challenging the Conventional Thinking – A Case Against 2 Out of 3 as Integrated Testing Strategy

Toxicological Sciences, Volume 159, Issue 1, 1 September 2017, Pages 3–5, https://doi.org/10.1093/toxsci/kfx115
Published: 27 June 2017

Henrik Johansson,  Robin Gradin

Background

Recent years have seen a surge in development of alternative methods for assessment of skin sensitizers. This has been in order to meet the regulatory and industrial demand for accurate safety assessment without the use of animal experimentation, and to address societal expectations. Today, 3 such assays are formally validated and have achieved OECD Guideline status (EC, 201320142015). However, partly due to insufficient predictive capacity, none of the validated assays have received a recommendation for use as a stand-alone method. In addition, there is a view that accurate hazard identification must be based upon an assessment of several key events in the relevant Adverse Outcome Pathway (AOP).

For these reasons it is proposed that tests are used in combinations, forming so-called Integrated Testing Strategies (ITSs), to address deficiencies in the performance of individual methods and to incorporate end points that reflect several key events in the AOP (Hartung etal., 2013Jaworska and Hoffmann, 2010Rovida etal., 2015). Although such ITSs may be configured in a number of ways, one heavily advocated approach relies on the majority vote of individual assays, often referred to as a 2 out of 3 ITS. That is, the identification of hazard is dependent upon the chemical eliciting a positive response in at least 2 of 3 test methods. This approach is based on the view that this will provide an increased weight of evidence and thereby greater confidence in hazard characterization and risk assessment.

Here, we present arguments opposing the claimed benefits of 2 out of 3 ITSs by examining the theoretical probability propagation of combined outcomes, simulated predictions generated by hypothetical assays, and actual data obtained from recently published literature. We argue that the added value of combining the top-performing assay with other assays with less predictive accuracy is overestimated, if present, and may actually be detrimental.

Link to full article

SenzaGen signs global distribution agreement with Charles River Laboratories

SenzaGen announces today that the company has signed a global distribution agreement with Charles River Laboratories, a leading early-stage contract research organization, to market GARDskin to their clients globally. GARDskin has the potential to replace traditional methods in regulatory testing, in accordance with European REACH Regulation.

GARDskin is a genome-based test that – with higher accuracy than the current gold standard test method – reveals whether chemical substances are at risk of causing allergies.

“With this new global distribution agreement, we are linking up with yet another very strong partner for the global launch of GARDskin. Charles River is a leading player in many important geographical markets and in several different industries, and we are looking forward to working together in the commercialization of SenzaGen’s high performing, accurate allergy test,” says SenzaGen CEO Anki Malmborg Hager.

Charles River Laboratories International, Inc. is a global company that specializes in a range of preclinical laboratory services for the pharmaceutical and biotechnology industries. Among its customers are many of the world’s leading pharmaceutical and biotechnology companies, academic institutions and government research centres. The company has more than 11,000 employees worldwide and is listed on the NYSE.

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

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 introduces GARDpotency – a unique method for measuring the allergenicity of chemical substances

SenzaGen AB announces today the start of pilot sales of GARDpotency, the first animal-free method of analysis that can provide invaluable information on the allergenic potency of a chemical substance. GARDpotency is a unique complement to the previously launched test method GARDskin.

For a long time there has been huge demand from government and industry to be able to quantify the strength of chemicals’ allergenicity. SenzaGen’s new in vitro test method GARDpotency makes this possible for the first time. Quantitative information is a requirement of REACH, the EU chemicals regulation, and is of great help to companies that develop new cosmetics, pharmaceuticals and food products. Until now all testing for potency classification has been carried out on animals.

As a first step in the launch of GARDpotency, SenzaGen will present the test method for potential customers in connection with the Society of Toxicology’s annual conference 12-16 March 2017 in Baltimore, USA. The technology behind GARDpotency has been developed by a research group at Lund University. At the conference, which brings together around 6,500 toxicologists from more than 60 countries, the research team will present two scientific papers describing GARDpotency as well as new application areas for GARDskin. Summaries of the research results will soon be made available and will also be available on the SenzaGen website after the scientific publications are published.

“We see great market potential for GARDpotency. It is already possible to determine if a chemical can cause allergies, but there is a significant additional need among both manufacturers and regulatory bodies to be able to quantify how strong the allergenic effect is. Until now no animal-free testing has been available and we are extremely proud to be the first to offer this to the chemicals industry,” says SenzaGen’s CEO, Anki Malmborg Hager.

GARDskin is scientifically validated and has been approved for validation in accordance with OECD requirements on allergy tests. The test provides greater than 90 percent accuracy in the classification of allergenic substances.

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

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.

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

 

Testing Human Skin and Respiratory Sensitizers—What Is Good Enough?

Int. J. Mol. Sci. 2017, 18(2), 241; doi:10.3390/ijms18020241

Malmborg A., Borrebaeck C. A.K.

Abstract

Alternative methods for accurate in vitro assessment of skin and respiratory sensitizers are urgently needed. Sensitization is a complex biological process that cannot be evaluated accurately using single events or biomarkers, since the information content is too restricted in these measurements. On the contrary, if the tremendous information content harbored in DNA/mRNA could be mined, most complex biological processes could be elucidated. Genomic technologies available today, including transcriptional profiling and next generation sequencing, have the power to decipher sensitization, when used in the right context. Thus, a genomic test platform has been developed, denoted the Genomic Allergen Rapid Detection (GARD) assay. Due to the high informational content of the GARD test, accurate predictions of both the skin and respiratory sensitizing capacity of chemicals, have been demonstrated. Based on a matured dendritic cell line, acting as a human-like reporter system, information about potency has also been acquired. Consequently, multiparametric diagnostic technologies are disruptive test principles that can change the way in which the next generation of alternative methods are designed.
Keywords:

genomics; skin sensitization; adverse outcome pathways; next generation in vitro tests

senzagen logga

SenzaGen and Bioglan working together for the next generation of test methods

SenzaGen has signed a cooperation agreement with the pharmaceutical company Bioglan, which develops and manufactures creams and ointments for the pharmaceutical and cosmetics industries. The collaboration means that Bioglan will test GARDskin for skin allergens in a number of creams that are included in various end products.

Bioglan is a pharmaceutical company that focuses on research, development and manufacture of medicines, especially semi-solids such as creams and ointments. Bioglan manufactures topical medicines and personal care products for customers within the pharmaceutical industry. The company works with everything from product development and clinical trials through to full-scale production. Safety testing and allergy testing are part of Bioglan’s everyday routine and today human skin patch tests are the preferred method of testing end products for skin allergies. SenzaGen’s GARDskin offers an alternative that may eventually replace these tests and therefore the two companies have now chosen to enter into a partnership where the use of GARDskin on complex end products will be further developed.

“With Bioglan we’ll benefit from an extensive exchange of knowledge and will have the opportunity to test GARDskin on several different formulations. We will also gain a deeper understanding of the extraction process, and can thus develop our products and processes further. Our goal is that GARDskin will work even on end products, and that more companies will therefore take note of our technology and realize that there are safer and better tests than the ones which are still routinely used in many places today,” says Anki Malmborg Hager, CEO of SenzaGen.

Bioglan, with its production in Malmö, seeks to depart from traditional testing methods on human skin and instead use the next generation’s GARD test for safety testing of the company’s products. GARDskin investigates and finds allergens in chemicals and pharmaceutical preparations through a unique genome technology that completely replaces the need for animal testing. The goal is that GARDskin should replace current tests, thus providing a better assessment of allergenicity and a more cost-effective approach.

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

Birgitta Svensson, Head of Development, Bioglan AB
Email: birgitta.svensson@bioglan.se
Phone: +46 40-287561, +46 708-149354

About Bioglan
Bioglan AB is your partner from product development through to full-scale manufacturing. We offer a total solution for all your production and service needs. Bioglan welcomes both small and large challenges, and is your partner of choice for

– One-off studies during product development
– Production of material for clinical trials (phase I – III)
– Commercial scale production for international markets

With more than twenty five years of experience in research, development and manufacturing of medicines, we can offer you all the services you need within the areas of semi-solids and liquids.

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 gold standard, animal tests in 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 Immunotechnology at Lund University. SenzaGen is based at Medicon Village in Lund, Sweden.