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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
Tel: +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.

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

GARD approved for validation within the OECD

GARD, Senzagen´s in vitro assay for sensitization, has been included in the OECD Test Guideline Programme (TGP) work plan with the TGP No  4.106. The decision was made at the WNT National Coordinators Test guideline programme meeting in the end of April. The validation process for GARD will now be initiated.

SenzaGen’s test Genomic Allergen Rapid Detection (GARD) has been reviewed by all OECD WNT (The Working Group of the National Coordinators of the Test Guidelines Programme (WNT)) task force members and has been included in the Test Guideline Programme. This means that the process of formally validating GARD can begin. The purpose of the validation process is to show that GARD is a reproducible assay that can be use by external laboratories. The assay will be transferred externally to perform a so called “ring trial”.

“This is a very important decision for the development of GARD as an international sensitization test and we are very confident we will have a successful ring trial. Even if our customers have been convinced by the quality of our test, it will make a big difference from a regulatory point of view when the test is validated”, says Anki Malmborg Hager.

The GARD test has been scientifically validated and has gone through successful in house validations prior to this with industrial partners. The test assay is based on a new innovative genomic technique which is argued to be the future of sensitization testing now that animal bans are more and more prevailing. As the chemical industry needs to find accurate and reliable tests, GARD will be an important player on the testing market once it has finalised its validation.

“The OECD WNT representatives were very interested and positive to the GARD test and to include it in the TGP work plan. The representatives also look forward to receiving information regarding the formal validation, when these results are available. The demand is high for new alternative test methods and it has been an interesting journey as a representative for Swedish Chemicals Agency (Kemikalieinspektionen) to present GARD to OECD as it has such great potential. I am very much looking forward to follow the future for this test”, says Henrik Appelgren, national coordinator at Kemikalieinspektionen.

Two external laboratories will now test GARD on several different chemicals to confirm that the test is reproducible. This process has started and final validation is expected within one year.

 

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

Brian Rogers, CEO, SenzaGen Inc
E-mail: brian.rogers@senzagen.com
Phone: +1 530 304 7648

 

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.

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Potency potential of chemicals using GARD shown by independent laboratory

The platform that forms the basis for the GARD sensitization assay, has been shown to have the potential to be an accurate tool for measuring the potency of sensitizing chemicals. The study was performed by an independent research group at Department of Immunotechnology, Lund University in Sweden and presented at the Society of Toxicology 55th Annual Meeting in New Orleans, 2016.

The new data were presented on Tuesday at the Society of Toxicology 55th Annual Meeting in New Orleans, poster session “Alternative Models for Ocular and Skin Toxicity”, abstract number 2205, P136.

“We have for a long time seen indications that this platform could predict potency and we are very happy to be able to present data that further points in that direction now, since it opens up completely new possibilities in skin sensitizations”, says Assoc. Prof. Malin Lindstedt, heading the group at Department of Immunotechnology.

Based at Medicon Village in Lund, SenzaGen develops and implements animal-free tests on chemicals and proteins for classification of sensitizers, primarily for the cosmetics and pharmaceutical industries. SenzaGen’s test GARD (Genomic Allergen Rapid Detection) measures significantly more parameters than existing tests on the market and has previously shown to deliver the most accurate prediction for hazard classification of chemicals. Now it has also shown potential to be a key player in the important field of risk assessment of chemicals by being able to predict the potency of chemicals.

“Potency has been the long-sought for application of sensitization tests. In risk assessment it is imperative to be able to predict not only the hazard of a chemical but more importantly how strong inducer of sensitization it is, i.e. the potency of the chemical. Lund University has now in a large study shown that GARD has this ability, which makes GARD unique, and we are looking forward to take part of this and develop it further”, says Anki Malmborg Hager, CEO of SenzaGen AB.

 

For more information:

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

Brian Rogers, CEO, SenzaGen Inc
E-mail: brian.rogers@senzagen.com
Phone: +1 530 304 7648

 

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 new customer – entry into the pharmaceutical industry

SenzaGen has signed a strategic contract with a major international pharmaceutical company. This means that SenzaGen’s test GARD will be used for the testing of drug candidates in early development. The agreement opens up a whole new market for GARD, which previously has been used primarily for testing in the cosmetics industry.

Based at Medicon Village in Lund, SenzaGen develops and implements animal-free allergy tests on chemicals and proteins. SenzaGen’s test GARD (Genomic Allergen Rapid Detection) has been developed over 15 years and measures significantly more parameters than existing tests on the market. This makes GARD a safer and more effective test than other available options.

So far, GARD has primarily been used for testing in the cosmetics industry to detect potential allergens in products, but it is now entering the pharmaceutical industry.

“Since the start, collaborations with pharmaceutical companies has been a major objective for SenzaGen. We see great potential in this market and we are looking forward to learning more about the industry, with an ambition to be able to develop and offer GARD to even more customers in the pharmaceutical industry”, says Anki Malmborg Hager, CEO SenzaGen

The main advantage of using GARD is that the test is based on genomic technology and is performed in vitro. This is the first time that a pharmaceutical customer uses SenzaGen’s method. The tests can be done in a very early phase of drug development, which helps pharmaceutical companies to develop safer drugs at faster pace and at a lower cost.

 

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

 

About SenzaGen
SenzaGen provides 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 and has 10 employees.

About GARD
By analyzing 200 and 389 markers, depending on the test, instead of 1-2 markers as competing methods do, GARD delivers results with 90 % prediction. This can be compared to the gold standard, animal tests on mice, that provide only 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. Existing, competing tests do not achieve sufficient specificity / sensitivity and lack the ability to measure the potency of a substance.

 

 

Ian Kimber joins the board of SenzaGen AB

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

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

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

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

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

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

Genomic allergen rapid detection in-house validation-a proof of concept.

Toxicol Sci. 2014 Jun;139(2):362-70. doi: 10.1093/toxsci/kfu046. Epub 2014 Mar 27.

Johansson H., Rydnert F., Kuehnl J., Schepky A., Borrebaeck C.A.K., Lindstedt M.

Abstract

Chemical sensitization is an adverse immunologic response to chemical substances, inducing hypersensitivity in exposed individuals. Identifying chemical sensitizers is of great importance for chemical, pharmaceutical, and cosmetic industries, in order to prevent the use of sensitizers in consumer products. Historically, chemical sensitizers have been assessed mainly by in vivo methods, however, recently enforced European legislations urge and promote the development of animal-free test methods able to predict chemical sensitizers. Recently, we presented a predictive biomarker signature in the myeloid cell line MUTZ-3, for assessment of skinsensitizers. The identified genomic biomarkers were found to be involved in immunologically relevant pathways, induced by recognition of foreign substances and regulating dendritic cell maturation and cytoprotective mechanisms. We have developed the usage of this biomarker signature into a novel in vitro assay for assessment of chemical sensitizers, called Genomic Allergen Rapid Detection (GARD). The assay is based on chemical stimulation of MUTZ-3 cultures, using the compounds to be assayed as stimulatory agents. The readout of the assay is a transcriptional quantification of the genomic predictors, collectively termed the GARD Prediction Signature (GPS), using a complete genome expression array. Compounds are predicted as either sensitizers or nonsensitizers by a Support Vector Machine model. In this report, we provide a proof of concept for the functionality of the GARD assay by describing the classification of 26 blinded and 11 nonblinded chemicals as sensitizers or nonsensitizers. Based on these classifications, the accuracy, sensitivity, and specificity of the assay were estimated to 89, 89, and 88%, respectively.

KEYWORDS:

GARD; allergic contact dermatitis; chemical sensitizers; in vitro assay; predictive assay; skin sensitization

Link to article on line

Evaluation of high throughput gene expression platforms using a genomic biomarker signature for prediction of skin sensitization.

BMC Genomics. 2014 May 16;15:379. doi: 10.1186/1471-2164-15-379.

Forreryd A., Johansson H., Albrekt A.S., Lindstedt M

Abstract

BACKGROUND:

Allergic contact dermatitis (ACD) develops upon exposure to certain chemical compounds termed skin sensitizers. To reduce the occurrence of skin sensitizers, chemicals are regularly screened for their capacity to induce sensitization. The recently developed Genomic Allergen Rapid Detection (GARD) assay is an in vitro alternative to animal testing for identification of skinsensitizers, classifying chemicals by evaluating transcriptional levels of a genomic biomarker signature. During assay development and biomarker identification, genome-wide expression analysis was applied using microarrays covering approximately 30,000 transcripts. However, the microarray platform suffers from drawbacks in terms of low sample throughput, high cost per sample and time consuming protocols and is a limiting factor for adaption of GARD into a routine assay for screening of potential sensitizers. With the purpose to simplify assay procedures, improve technical parameters and increase sample throughput, we assessed the performance of three high throughput gene expression platforms–nCounter®, BioMark HD™ and OpenArray®–and correlated their performance metrics against our previously generated microarray data. We measured the levels of 30 transcripts from the GARD biomarker signature across 48 samples. Detection sensitivity, reproducibility, correlations and overall structure of gene expression measurements were compared across platforms.

RESULTS:

Gene expression data from all of the evaluated platforms could be used to classify most of the sensitizers from non-sensitizers in the GARD assay. Results also showed high data quality and acceptable reproducibility for all platforms but only medium to poor correlations of expression measurements across platforms. In addition, evaluated platforms were superior to the microarray platform in terms of cost efficiency, simplicity of protocols and sample throughput.

CONCLUSIONS:

We evaluated the performance of three non-array based platforms using a limited set of transcripts from the GARD biomarker signature. We demonstrated that it was possible to achieve acceptable discriminatory power in terms of separation between sensitizers and non-sensitizers in the GARD assay while reducing assay costs, simplify assay procedures and increase sample throughput by using an alternative platform, providing a first step towards the goal to prepare GARD for formal validation and adaption of the assay for industrial screening of potential sensitizers.

Link to article on line