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.
Press release in pdf
GARD™ – the future of sensitization testing and safety assessment of chemicals, using a genomics-based platform
Henrik Johansson, Andy Forreryd, Olivia Larne, Ann Sofie Albrekt, Carl Arne Krister Borrebaeck, Malin Lindstedt
SenzaGen, Sweden, Lund, Department of Immunotechnology, Lund University, Sweden, Lund
Background
Genomic Allergen Rapid Detection, GARD, is an in vitro test developed for the prediction of sensitizing chemicals. It is based on differential expression of disease-associated genomic biomarkers in a human myeloid dendritic cell line.
Here, we describe the development, scientific validation, applications and the current state of the GARD platform. The scientific rationale behind the use of genomic biomarker signatures are detailed, linked to the AOP in a biological context, and to advantages realized through multivariate computational prediction models in a technological context.
Resume
GARDskin
– Hazard identification of skin sensitizers
– Accuracy: ~90%
– Initiated ECVAM validation (OECD TGP no. 4.106)
GARDair
– Hazard identification of respiratory sensitizers
– Accuracy: ~85%
Poster:
GARD–the future of sensitization testing and safety assessment of chemicals, using a genomics-based platform
SenzaGen Invited to High-Tech Health Research Expo in Washington, D.C.
SenzaGen have been invited by U.S. Representative Tom Marino to present the company’s technology at the High-Tech Health Research Expo in Washington, D.C., where SenzaGen will meet US congressmen and federal procurement officials interested in the use of high-tech human-focused methods to replace animal tests. The Expo takes place on September 15th, 2016.
The High-Tech Health Research Expo is organized by U.S. Representative Tom Marino who has been an outspoken leader for increased investments in this sector of the healthcare industry. The market for alternative and animal-free test methods is growing rapidly and there is a great interest for its benefits – scientifically and economically as well as from a public health perspective.
-The provisions to reduce animal testing under the reformed Toxic Substances Control Act (TSCA) will ensure an even bigger interest in the field and SenzaGen has a natural fit in this with its test being validated for the international market by OECD says Brian Rogers, CEO of SenzaGen Inc.
At the Expo, selected companies will have the opportunity to present their technologies to Members of congress, congressional staffers and other representatives from different government agencies. The goal of the Expo is to help advance this sector of the healthcare industry by creating an opportunity for the best and the brightest in the field to efficiently reach the largest number of decision-makers at once.
-We are very proud to participate. Now, our US subsidiary will have the opportunity to reach out to some of the most influential members of Congress, who really have a say in our industry. We see it as a confirmation of our US investment and our unique test method GARD says Anki Malmborg-Hager, CEO of SenzaGen Sweden.
High-Tech Health Care Expo takes place at the Cannon House Office Building in Washington, DC on September 15, 2016. SenzaGen will participate with their U.S: employees, and will have a stand where the company will demonstrate the latest technique to replace animal testing when performing allergy testing of chemicals and chemical ingredients.
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, +1 530 867 5600
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.
Press release in pdf
SenzaGen inbjudna till High-Tech mässa i amerikanska kongressen
SenzaGen har bjudits in av den amerikanske kongressmannen Tom Marino att presentera företagets teknologi på High-Tech Health Research Expo i Washington, DC. Där kommer SenzaGen att möta amerikanska kongressledamöter och federala upphandlingstjänstemän som är intresserade av tekniker som ersätter djurförsök. Mässan äger rum den 15 september 2016.
High-Tech Health Research Expo arrangeras av Tom Marino, som är republikansk ledamot för Pennsylvania i USA:s representanthus, och en stark förespråkare för ökade investeringar i alternativa djurfria testmetoder. Marknaden för alternativa och djurfria testmetoder växer snabbt och det finns ett stort intresse för dess fördelar – vetenskapligt och ekonomiskt såväl som ur ett folkhälsoperspektiv.
-Uppdraget att minska antalet djurförsök i och med den reformerade Toxic Substances Control Act (TSCA) säkerställer ett ännu större intresse inom området för djurfria testmetoder. SenzaGen har en naturlig plats i detta med sitt GARD test som just nu valideras av OECD för den internationella marknaden, säger Brian Rogers, VD för SenzaGen Inc.
På mässan kommer utvalda företag ha möjlighet att presentera sin verksamhet och teknik till medlemmar av kongressen samt ett stort antal viktiga beslutsfattare och upphandlare från olika myndigheter. Målet med mässan är att bidra till att öka intresset och kunskaperna kring metoder som ersätter djurförsök genom att skapa en möjlighet att lyfta de främsta företagen på området så att de på ett effektivt sätt kan nå ett stort antal beslutsfattare på en gång.
‒ Vi är mycket stolta över att få medverka. Nu har vår amerikanska verksamhet möjlighet att nå några av de mest inflytelserika kongressledamöter som har mycket att säga till om i vår bransch. Vi ser det som en bekräftelse på vår amerikanska satsning och vår unika testmetod GARD säger Anki Malmborg-Hager, VD på SenzaGen AB.
High-Tech Health Care Expo äger rum på Cannon House Office Building i Washington, DC den 15 september, 2016.
SenzaGen deltar med sina amerikanska medarbetare med en monter där företaget kommer att visa den senaste tekniken för att ersätta djurförsök vid säkerhets- och allergitestning av kemikalier och kemiska ingredienser.
För mer information
Anki Malmborg Hager, CEO, SenzaGen AB
E-mail: amh@senzagen.com
Phone: +46 768 284822
Brian Rogers, CEO US
E-mail: brian.rogers@senzagen.com
Phone: +1 530 304 7648, +1 530 867 5600
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.
Pressmeddelande som pdf
From genome-wide arrays to tailor-made biomarker readout – Progress towards routine analysis of skin sensitizing chemicals with GARD.
Toxicol In Vitro. 2016 Dec;37:178-188. doi: 10.1016/j.tiv.2016.09.013. Epub 2016 Sep 13.
Forreryd A., Zeller K., Lindberg T., Johansson H., Lindstedt M
Abstract
Allergic contact dermatitis (ACD) initiated by chemical sensitizers is an important public health concern. To prevent ACD, it is important to identify chemical allergens to limit the use of such compounds in various products. EU legislations, as well as increased mechanistic knowledge of skin sensitization have promoted development of non-animal based approaches for hazard classification of chemicals. GARD is an in vitro testing strategy based on measurements of a genomic biomarker signature. However, current GARD protocols are optimized for identification of predictive biomarker signatures, and not suitable for standardized screening. This study describes improvements to GARD to progress from biomarker discovery into a reliable and cost-effective assay for routine testing. Gene expression measurements were transferred to NanoString nCounter platform, normalization strategy was adjusted to fit serial arrival of testing substances, and a novel strategy to correct batch variations was presented. When challenging GARD with 29 compounds, sensitivity, specificity and accuracy could be estimated to 94%, 83% and 90%, respectively. In conclusion, we present a GARD workflow with improved sample capacity, retained predictive performance, and in a format adapted to standardized screening. We propose that GARD is ready to be considered as part of an integrated testing strategy for skin sensitization.
Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
KEYWORDS:
GARD; In vitro assay; Predictive genomic biomarker signature; Skin sensitization
Link to articel on line
SenzaGen Genomics – the future of sensitization testing and assessment
Anki Malmborg Hager elected one of the two most powerful people among Lund technology companies according to Rapidus ranking
Rapidus writes:
Leeding up to the expansion of the concept of Ideon, Rapidus went through the records of company boards and chief executives of all technology companies which have their registered office at Ideon Medicon Village, Mobile Heights Center and Edison Park.
In total it ads up to around 700 decision makers of almost 180 companies. Most of them only sit on one board or CEO positions however 56 of these people have posiotions in more than one technology company on the extended Ideon area. At the top of the list are a dozen people with at least three appointments, including the CEO of Jolife Erik von Schenck and Professor Carl Borrebaeck, who among several appointments is on the board of Alligator Bioscience and Clinical Laserthermia Systems.
Read the full news at Rapidus site (only subscribers)
Nu bloggar vi för Dagens Industri! SenzaGen tar över stafettpinnen i DI:s Gasellsprånget
Hej!
Som årets vinnare i DI:s Gasellsprånget är det nu dags för oss på SenzaGen att ta över stafettpinnen att blogga för DI efter Maria Forssell på BioCool AB. Texterna hittar ni även här hos oss. Vi är glada för det förtroende vi fått av DI och Gasellsprånget och hoppas kunna bidra med nya kunskaper om vårt bolag och våra produkter samtidigt som vi vill dela med oss om våra tankar om entreprenörskap inom vår bransch som ett spin-out företag från forskningsvärlden.
Jag vill först passa på att tacka Maria Forssell för hennes generositet och de insikter som hon delat med sig i bloggen och direkt med oss. Lycka till!
Det är bråda tider för oss på Senzagen, det är mycket som ska på plats innan det är dags för semester. Som för er alla, misstänkter jag. Man tror alltid att man ska hinna mer än man gör och nu har det ju varit extra körigt eftersom vi har haft ett helt fotbolls-EM att spela också.
Vad är då SenzaGen? SenzaGen är ett litet innovationsbolag med rötterna i forskningsvärlden i Lund. Vår affärsidé går enkelt uttryckt ut på att använda odlade mänskliga celler och genteknologi, för att testa om olika ämnen är allergiframkallande. Det är viktigt av en rad olika skäl. Genom att använda vår metod, GARD (Genomic Allergen Rapid Detection), kan företag som tillverkar olika typer av konsumentprodukter som smink, krämer, rengöringsprodukter och läkemedel testa att ämnen i deras produkter inte framkallar allergier, och därmed kan dessa företag ta fram bättre och säkrare produkter.
Vår metod har visat sig vara mer effektiv än befintliga test på marknaden. Och GARD kan dessutom ersätta djurförsök. Vad många inte känner till är att försäljning av djurtestad kosmetika och hygienprodukter är förbjudet inom EU sedan 2013 och att flera stora länder nu väljer att ta efter. Även om vi idag skriver 2016 måste vi dock tyvärr konstatera att arbetet med att följa lagstiftningen har gått ganska trögt. Arbetet med att ta fram alternativa metoder till djurförsök är en utmaning. Att det är klurigt rent vetenskapligt kan man ju inse, men att det faktum att människor av naturen är motståndare till förändringar ska ligga så djupt är något vi brottas med dagligen. Att ändra sina vanor och acceptera en förändring är inte självklart, trots att lagen kräver det. Visste ni att många kosmetikabolag har inte lanserat en enda ny ingrediens sedan 2013, eftersom man är osäker på hur man ska testa att den är säker?
Det är en utmaning, men samtidigt det som driver oss. Som ni förstår så brinner vi på SenzaGen för att sprida vår metod och på sikt etablera en ny standard för säkerhetstester på en rad olika produkter. Det var ett av skälen till att jag valde att engagera mig i bolaget. Även om vi är ett litet bolag har vi förhoppningar om att kunna vara med och bidra till att vi alla kan försäkra oss om att de produkter vi använder inte ger oss allergi och vara ett bättre alternativ till dagens djurförsök.
/Anki Malmborg Hager
Anki Malmborg Hager, VD på SenzaGen AB sedan 2014
Ålder: 50 år
Utbildning: Civilingenjör i kemiteknik LTH, PhD i Immunteknologi Lunds universitet, MBA Falconbury
Erfarenhet: Post-doc på UC Davis, Forskarassistent på avd för Immunteknologi LU, VP Business Development på Alligator Bioscience AB, Investment director på LU Bioscience AB, VD på Cantargia AB, XImmune AB och DiaProst AB.
Nuvarande styrelseuppdrag: Diaprost AB, Immunovia AB, Avena partners AB
Intressen: Resor, fotboll och vin.
SenzaGen AB
Medicon Village, Scheelevägen 2, 223 81 Lund
www.senzagen.com
+46 (0)46 2756200 (vxl)
info@senzagen.com
Anki Malmborg Hager, VD
amh@senzagen.com
+46 76 8284822
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 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.
SenzaGen starts blogging for Swedish leading financial newspaper Dagens Industri.
Follow our CEO, Anki Malmborg Hager here on the new blog at our web site under Mixed Media/blogs or at Di Gasell.
The blog will be in Swedish
SenzaGen initiates cooperation with partners in Europe and the US
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.
Press release in pdf
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:
CEO, SenzaGen AB
E-mail: amh@senzagen.com
Phone: +46 768 284822
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.