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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 […]

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 Trial SenzaGen’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.

 

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SenzaGen initiates cooperation with partners in Europe and the US

Thu, Jun 09, 2016 09:00 CET 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 […]

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 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.

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 Buleson 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.

SenzaGen inleder samarbete med partners i Europa och USA

to, jun 09, 2016 09:00 CET Det sista och viktigaste steget i SenzaGen´s formella valideringsprocess av sensibiliseringstestet GARD har nu påbörjats genom samarbeten med två externa laboratorier, Eurofins (Tyskland) och Burlesons (USA). Dessa partners kommer nu att verifiera GARD:s tillförlitlighet och reproducerbarhet, vilket innebär att testet sedan kan utföras av externa kontraktslaboratorier. I denna s.k. […]

Det sista och viktigaste steget i SenzaGen´s formella valideringsprocess av sensibiliseringstestet GARD har nu påbörjats genom samarbeten med två externa laboratorier, Eurofins (Tyskland) och Burlesons (USA). Dessa partners kommer nu att verifiera GARD:s tillförlitlighet och reproducerbarhet, vilket innebär att testet sedan kan utföras av externa kontraktslaboratorier.

I denna s.k. ”ring trial” kommer SenzaGens partners, tyska Eurofins BioPharma Product Testing och amerikanska Burlesons Research Technologies, förses med ett flertal kodade kemikalier som ska testas med GARD. Genom att verifiera att GARD är ett robust och reproducerbart test öppnas en ny marknad för SenzaGen, samtidigt som det bekräftar GARD:s unika egenskaper.

“Med validering och verifiering av GARD som ett robust test kan vi nu introducera GARD på bred front i våra prioriterade branscher”, säger Anki Malmborg Hager, VD på SenzaGen.

GARD har sedan tidigare genomgått såväl vetenskaplig som industriell validering. Testmetoden, som är baserad på en innovativ genomteknik, erbjuder ett alternativ till befintliga tester när djurförsök förbjuds i allt större utsträckning.

“Med en lyckad ”ring trial” får vi och våra befintliga kunder ytterligare en bekräftelse på GARD:s kvalitet och effektivitet, och det kommer innebära nya möjligheter för oss, inte minst ur ett regulatoriskt perspektiv”, säger Anki Malmborg Hager, VD på SenzaGen.

Den påbörjade valideringen hos Eurofins och Burleson kommer att pågå under hösten och rapporteras därefter till EURL-ECVAM för granskning och godkännande. Resultatet av valideringen ger ytterligare och förstärkta möjligheter att introducera GARD på olika kontraktslaboratorium vilket ger ökad marknadspenetration.

För mer information:

Anki Malmborg Hager,
VD, SenzaGen ABE-mail: amh@senzagen.com

Telefon: +46 768 284822

Brian Rogers,
VD, SenzaGen IncE-mail:
brian.rogers@senzagen.com

Telefon: +1 530 304 7648


Om GARD

Genom att analysera 200 respektive 389 markörer beroende på test, genererar GARD stora mängder data och levererar resultat med 90 % tillförlitlighet. Detta kan jämföras med den gyllene standarden som är djurtester på möss som ger endast 72 % tillförlitlighet. SenzaGens test har därtill förmågan att mäta potensen (styrkan) av en substans och kan därmed avgöra till vilken grad en substans orsakar allergi.

Om SenzaGen

SenzaGen erbjuder in vitro-tester för hud och luftvägar till kosmetisk, kemisk och farmaceutisk industri som ersätter behovet av djurförsök. Bolagets unika test GARD är baserat på forskning från Institutionen för Immunteknologi vid Lunds Tekniska Högskola. SenzaGen är baserat på Medicon Village i Lund, Sverige.

Om Eurofins BioPharma Product Testing, München

Eurofins är en av världens största laboratoriegrupper med över 23 000 anställda i 39 länder och mer än 225 laboratorium över hela världen. Bolaget erbjuder heltäckande testning av bland annat läkemedelssubstanser, ingredienser och slutprodukter för läkemedel och kosmetika samt kemiska och mikrobiologiska analyser inom kretsloppets olika delar – lantbruk, livsmedel och miljö

Om Burlesons Research Technologies

Burleson Research Technologies (BRT) är ett kontraktslaboratorium (CRO) i North Carolina som tillhandahåller laboratorietjänster till kunder inom bioteknik, läkemedel, kemisk tillverkning, myndighets- och hälsovårdsindustri med proof-of-concept, prekliniska och kliniska immunotoxikologiska studier.

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