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

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.

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.

SenzaGen signs distribution agreement in Korea

SenzaGen has signed a distribution agreement with the Korean company WOOJUNG BSC, Inc.  Korea passed a legislation to ban animal testing of cosmetics on December 2015, which will be effective on February 4, 2017. With this new agreement, SenzaGen will enter one of the world’s most exciting markets and WOOJUNG BSC will market GARDskin for the field of cosmetics in Korea.

-Collaborating with new strong partners is an integral part of our business model. The agreement with WOOJUNG BSC means that we will be present in one of the most important Asian markets. Korea, just as India, has imposed a ban on animal testing on cosmetics. WOOJUNG BSC has a wide network of customers and partners in the life science sector, and also the company has been offering various solutions to the pharmaceutical GMP market and preclinical CRO services. This provides long-term benefits to our product portfolio and SenzaGen, says Anki Malmborg Hager, CEO of SenzaGen.

Korean company WOOJUNG BSC was established in 1989 and is one of the leading research facilities in Korea. Customers include universities, pharmaceutical companies and research institutes, to which WOOJUNG BSC provides services.

-We offer a range of services to leading cosmetic and pharmaceutical companies and universities in Korea and with GARD we will expand and strengthen our offer. With the new legislation, we see that more and more of our customers will demand animal-free tests and with GARD, we get a safer and better test. It benefits us, our customers and all consumers, says Benjamin, ByungNyun Chun, CEO at WOOJUNG BSC.

Since 2013, animal testing of cosmetic products is banned in the EU. Norway has decided to impose the same ban as the EU, while India, Israel, New Zealand and Turkey have introduced bans on carrying out animal testing for cosmetics in the country. In December 2015, Korea passed a similar ban which will come into effect in 2017. More bans are underway in major markets in the coming years, which provides an increasing demand for SenzaGens animal-free genomic testing.

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

About WOOJUNG BSC Connecting Life, Science and Research
For the last 26 years WOOJUNG BSC has been a class-leading-pioneer for the development field of animal laboratory facility and research. Providing safest and most efficient solution to the laboratory and animal researching environment, have been built many top quality laboratories and providing research solutions such as in vitro, in vivo contract research. The company is confident that cutting edge facilities constructed under WOOJUNG BSC’s name is the most beneficial for the each component of world; human, animal and environment. Scientists and researchers can be always assured that they are in SAFE SHELTER (WOOJUNG).

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.

SenzaGen signs its first distribution agreement with British XCellR8, a leader in animal-free testing

In line with SenzaGen’s long-term strategy and business model, the company has now signed its first distribution agreement with the British test lab company XCellR8. The agreement confirms the interest in SenzaGen’s technology and opens up new business opportunities as XCellR8 will actively market the GARDskin for cosmetics, personal care and household products and their ingredient suppliers globally.

– This agreement is important for us, not only because we now see that our business model works, we also see that there is an increased interest in our technology and we get access to a new market with a well-established and highly competent and renowned partner. XCellR8 is one of the industry’s foremost ambassadors of non-animal tests, says Anki Malmborg Hager, CEO of SenzaGen.

XCellR8 was established in 2008 with a mission to replace animal testing with methods that are both scientifically advanced and ethically sound. The company works with a number of leading global cosmetic companies and their ingredient suppliers, and has become the “go-to” laboratory for in vitro testing expertise for both product safety and efficacy / claim support.

-By working with GARD we take a step into the future. With the use of genomics based testing we are moving towards safer and better tests, and ultimately more reliable consumer products without the need for animal testing, says Dr Carol Treasure, CEO of XCellR8

About XCellR8
XcellR8 offers animal-free testing for companies with products on the cosmetic, personal care and household product market and their ingredients suppliers. The company helps customers develop safe and innovative new products, to follow the law, and to choose non-animal test methods that are both scientifically advanced and ethical. XCellR8 ‘s British laboratory is accredited according to GLP standard (Good Laboratory Practice), which means that the company can offer their customers test results that can be used according to regulatory requirements to prove product safety. XCellR8 are proactive and contributing to the global commitment to replace animal testing through research and education programs.

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.

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

Carol Treasure, Founder & MD, XCellR8
Email: carol.treasure@x-cellr8.com
Mobile: +44 7899 845222

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.