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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.

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.

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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.