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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.

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                                 Birgitta Svensson, Head of Development
Email: amh@senzagen.com                                                            Email: birgitta.svensson@bioglan.se
Phone: +46 768 284822                                                                   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.

Anki Malmborg Hager

SenzaGen invited to prestigious meeting at ICCVAM, US

Today, Tuesday the 27 September SenzaGen is invited to participate at a science Committee Meeting of the American organization ICCVAM *, which promotes the development of alternative methods to replace animal testing. Together with its US partner, Burleson Research Technologies, Inc., SenzaGen will participate in the official program and make a statement about Skin Sensitization Testing, the importance of secure and robust tests for classification of chemical substances with the ability to identify the potential of a substance causing allergy.

US ICCVAM is a permanent committee consisting of representatives from 15 federal regulatory and research agencies that requires, uses, generates, or disseminates toxicological and safety testing information to replace animal experiments. ICCVAM take expert advice from SACATM **, whose members include stakeholders from regulated industries, animal welfare organizations, academia, U.S. state or international regulatory bodies, and companies or organizations that develop, market or use test methods.

In connection with the SACATM meeting SenzaGen was invited together with their partner Burleson Research Technologies to make a statement in the session for Skin Sensitization Testing.

“It is a great achievement for us that we now have the opportunity, together with our partner Burleson Research Technologies, to give our views on the future development of testing in the U.S and to present GARD, before members of the prestigious SACATM. This shows that GARD is already on their radar, as the next-generation of sensitization testing. Only by cooperating at the highest level can we set a new industry standard for allergy testing in the US market, says Anki Malmborg Hager,” CEO of SenzaGen.

The ICCVAM meeting is being held in Research Triangle Park, North Carolina on Tuesday, 27 September and the CEO of SenzaGen AB, Anki Malmborg Hager will make her statement and give the recommendations in the session ICCVAM Roadmap to Skin Sensitization Testing at 11.25 am (EDT).

* ICCVAM: The Interagency Coordinating Committee on the Validation of Alternative Methods
** SACATM: Scientific Advisory Committee on Alternative Toxicological Methods

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

 

About GARD
By analyzing 200 and 389 markers, depending on the test, GARD generates massive amounts of data and delivers results with 90 % prediction accuracy. This can be compared to the 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.

Anki Malmborg Hager

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

 

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

 

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.

SenzaGen initiates cooperation with partners in Europe and the US

The final and most important step in SenzaGen’s formal validation process of the sensitization test GARD has now commenced through partnerships with two external laboratories, Eurofins (Germany) and Burleson (USA). These partners will now verify GARD’s reliability and reproducibility, which will allow the test to be carried out by external contract laboratories.

In this Ring TrialSenzaGen’s partners, Eurofins BioPharma Product Testing in Germany and Burleson Research Technologies in the US, will be provided with a number of encoded chemicals to be tested with GARD. The verification of GARD as a robust and reproducible test will open up a new market for SenzaGen, at the same time confirming GARD’s unique characteristics.

“With the validation and verification of GARD as a robust test, we can now promote GARD on a broad front in our priority sectors,” says Anki Malmborg Hager, CEO of SenzaGen.

GARD has previously undergone both scientific and industrial validation. The test method, which is based on an innovative genomic technology, offers an alternative to existing tests at a time when animal testing is increasingly prohibited.

“With a successful Ring Trial we and our existing customers will have further confirmation of GARD’s quality and efficiency, and it will open up new opportunities for us, not least from a regulatory perspective,” says Anki Malmborg Hager, CEO of SenzaGen.

The current validation by Eurofins and Burleson will run during the fall and then be reported to EURL ECVAM for review and approval. The result of the validation will provide additional and enhanced opportunities to introduce GARD at various contract laboratories, thus providing increased market penetration.

 

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 Eurofins BioPharma Product Testing, Munich
Eurofins is one of the world’s largest laboratory groups with over 23,000 employees in 39 countries and more than 225 laboratories worldwide. The company offers comprehensive service that include testing of drug substance, final product, intermediates, and starting materials for both small and large molecule drug products as well as chemical and microbiological analyses in agriculture, food and environment.

About Burleson Research Technologies
Burleson Research Technologies (BRT) is a Contract Research Organization (CRO) in North Carolina that provides laboratory services to clients from the biotechnology, pharmaceutical, chemical manufacturing, government, and healthcare industries with proof-of-concept, preclinical, and clinical immunotoxicology studies.

 

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 Immuno Technology at Lund University. SenzaGen is based at Medicon Village in Lund, Sweden.

SenzaGen wins DI’s Gasellsprånget – most promising company to become Supergasell within 5 years

On May 25, SenzaGen was elected winner at the Swedish newspaper Dagens Industri’s event and competition Gasellsprånget, at the national finale in Gothenburg. After a tough round of questions and an audience poll, SenzaGen was elected winner with the greatest market potential and future outlook, leaving the competitor DigiExam a close second.

“SenzaGen has great future potential in a new and growing global market. We have been working very hard which makes it particularly rewarding to receive this award and the attention it creates. We are seeing an increased interest in our technology and I am confident that this award will lead to more exciting business opportunities in Europe and globally, says Anki Malmborg Hager”, CEO of SenzaGen.

About Gasellsprånget
Gasellsprånget is a competition highlighting Swedish growth companies on the rise. The competition is hosted by the Swedish newspaper Dagens Industri and is split into several regional competitions, from which two contestants are chosen to participate in the national finale.

“In the selection of finalists for Gasellsprånget 2016, the jury nominated the companies that have the best opportunities to become Supergasell within a 5-year period, based on analysis and on-stage presentations by the competing companies.”

 

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

 

About SenzaGen
SenzaGen provides in vitro dermal and respiratory 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.

 

About GARD
By analysing 200 and 389 genomic markers, depending on the test, instead of 1-2 markers as competing methods, GARD delivers results with 90 % accuracy. This can be compared to the golden standard, animal tests on mice, that provide 72 % accuracy. SenzaGen’s test also has the ability to measure potency (strength) of a substance and can thus determine the degree to which a substance cause allergy.

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.

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.

 

 

djurfria allergitester

SenzaGen receives Honorary Prize in PwC’s annual Innovation Award

In the competition for This year’s Innovation appointed by PwC and Lund Innovation Systems, Malin Lindstedt and Anki Malmborg Hager at SenzaGen gets the Honorary Prize and is awarded 50.000 SEK.

At the awards ceremony held at Lund City Hall the winner received a prize of SEK 150 000 and two other projects; SenzaGen “Animal free allergy test” and Erghis “Touchless Interaction in Healthcare” received a Honorary prize for their inventions.

Congratulations to Malin and Anki for their great achievements of innovative research and commercialisation of the invention of high relevance for the industry.