Posts

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.

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.