senzagen skin derma

Meet us in Almedalen – The researchers behind the GARDtest and SenzaGen’s lab technicians on site.

Meet Andy Forreryd from Lund University and Angelica Johansson from SenzaGen in the organisation of Research Without Animal Experiments, 6th and 7th of July. During two seminars, Andy will tell us about the research behind GARD. There will be opportunities for questions and hands on practical lab work so that you can experience and see […]

Meet Andy Forreryd from Lund University and Angelica Johansson from SenzaGen in the organisation of Research Without Animal Experiments, 6th and 7th of July. During two seminars, Andy will tell us about the research behind GARD. There will be opportunities for questions and hands on practical lab work so that you can experience and see how the test works.

With research money from different organisations, including Research Without Animal Experiments, the university has developed a unique allergy test that with higher precision than existing tests can determine if a chemical can induce skin allergy. The test is carried out in test tubes and replaces the need for animal testing when safety testing chemicals.

The GARDtestet is now owned, sold and marketed by SenzaGen AB for global commercialization with the aim of becoming a new industry standard on the international chemical safety testing market. Angelica Johansson is on site to talk about GARD’s journey from laboratory to global market. Link in Swedish.

Skin Sensitization: Challenging the Conventional Thinking – A Case Against 2 Out of 3 as Integrated Testing Strategy

Toxicological Sciences, Volume 159, Issue 1, 1 September 2017, Pages 3–5, https://doi.org/10.1093/toxsci/kfx115 Published: 27 June 2017 Henrik Johansson,  Robin Gradin Background Recent years have seen a surge in development of alternative methods for assessment of skin sensitizers. This has been in order to meet the regulatory and industrial demand for accurate safety assessment without the use […]
Toxicological Sciences, Volume 159, Issue 1, 1 September 2017, Pages 3–5, https://doi.org/10.1093/toxsci/kfx115
Published: 27 June 2017

Henrik Johansson,  Robin Gradin

Background

Recent years have seen a surge in development of alternative methods for assessment of skin sensitizers. This has been in order to meet the regulatory and industrial demand for accurate safety assessment without the use of animal experimentation, and to address societal expectations. Today, 3 such assays are formally validated and have achieved OECD Guideline status (EC, 201320142015). However, partly due to insufficient predictive capacity, none of the validated assays have received a recommendation for use as a stand-alone method. In addition, there is a view that accurate hazard identification must be based upon an assessment of several key events in the relevant Adverse Outcome Pathway (AOP).

For these reasons it is proposed that tests are used in combinations, forming so-called Integrated Testing Strategies (ITSs), to address deficiencies in the performance of individual methods and to incorporate end points that reflect several key events in the AOP (Hartung etal., 2013Jaworska and Hoffmann, 2010Rovida etal., 2015). Although such ITSs may be configured in a number of ways, one heavily advocated approach relies on the majority vote of individual assays, often referred to as a 2 out of 3 ITS. That is, the identification of hazard is dependent upon the chemical eliciting a positive response in at least 2 of 3 test methods. This approach is based on the view that this will provide an increased weight of evidence and thereby greater confidence in hazard characterization and risk assessment.

Here, we present arguments opposing the claimed benefits of 2 out of 3 ITSs by examining the theoretical probability propagation of combined outcomes, simulated predictions generated by hypothetical assays, and actual data obtained from recently published literature. We argue that the added value of combining the top-performing assay with other assays with less predictive accuracy is overestimated, if present, and may actually be detrimental.

Link to full article

SenzaGen tecknar globalt distributionsavtal med Charles River Laboratories

on, jun 28, 2017 08:30 CET SenzaGen tillkännager idag att företaget har tecknat ett globalt distributionsavtal med Charles River Laboratories, ett världsledande företag inom laboratorietjänster. Charles River kommer marknadsföra GARDskin till sina kunder på global basis. GARDskin har potential att ersätta traditionella metoder vid regulatorisk testning och utvärdering av kemiska substanser inom ramarna för den […]

SenzaGen tillkännager idag att företaget har tecknat ett globalt distributionsavtal med Charles River Laboratories, ett världsledande företag inom laboratorietjänster. Charles River kommer marknadsföra GARDskin till sina kunder på global basis. GARDskin har potential att ersätta traditionella metoder vid regulatorisk testning och utvärdering av kemiska substanser inom ramarna för den europeiska REACH-förordningen.

GARDskin är ett genbaserat test som, med högre noggrannhet än de tester som idag dominerar marknaden, avslöjar om kemiska substanser riskerar att framkalla allergier.

“Med detta nya globala distributionsavtal knyter vi till oss ännu en mycket stark partner för den globala lanseringen av GARDskin. Charles River är en ledande aktör på många viktiga geografiska marknader och i flera olika branscher och vi ser fram emot att arbeta tillsammans i kommersialiseringen av SenzaGens högpresterande och tillförlitliga allergitest “, säger SenzaGens VD Anki Malmborg Hager.

Charles River Laboratories International, Inc. är ett globalt företag som specialiserat sig på en rad prekliniska laboratorietjänster inom läkemedels- och bioteknikindustrin. Bland sina kunder finns många av världens ledande läkemedels- och bioteknikföretag, akademiska institutioner och offentliga forskningscentra. Företaget har mer än 11 ​​000 anställda över hela världen och är noterat på NYSE.

För mer information:
Anki Malmborg Hager, VD, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telefon: 0768 284822

Om GARD
Genom att analysera 200 respektive 389 markörer beroende på test, genererar GARD stora mängder data och levererar resultat med upp till 90 % precision. Detta kan jämföras med den gyllene standarden som är djurtester på möss som har endast 70-75% precision. 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 gör det möjligt att ersätta djurförsök med genetiska tester i provrör för att bedöma om de kemikalier vi kommer i kontakt med i vår vardag är allergiframkallande. Det kan till exempel handla om kosmetika, läkemedel, livsmedel och färgämnen. Bolagets patentskyddade tester är de mest tillförlitliga på marknaden och ger mer information än traditionella utvärderingsmetoder. Testerna säljs i egen regi i Sverige och USA, och genom partners i flera andra länder. De närmaste åren kommer bolaget expandera geografiskt, knyta till sig fler distributionspartners och lansera nya, unika tester. SenzaGen har sitt huvudkontor i Lund och dotterbolag i San Francisco, USA. För mer information, besök www.senzagen.com

Pressmeddelande som pdf

SenzaGen signs global distribution agreement with Charles River Laboratories

Wed, Jun 28, 2017 08:30 CET SenzaGen announces today that the company has signed a global distribution agreement with Charles River Laboratories, a leading early-stage contract research organization, to market GARDskin to their clients globally. GARDskin has the potential to replace traditional methods in regulatory testing, in accordance with European REACH Regulation. GARDskin is a […]

SenzaGen announces today that the company has signed a global distribution agreement with Charles River Laboratories, a leading early-stage contract research organization, to market GARDskin to their clients globally. GARDskin has the potential to replace traditional methods in regulatory testing, in accordance with European REACH Regulation.

GARDskin is a genome-based test that – with higher accuracy than the current gold standard test method – reveals whether chemical substances are at risk of causing allergies.

“With this new global distribution agreement, we are linking up with yet another very strong partner for the global launch of GARDskin. Charles River is a leading player in many important geographical markets and in several different industries, and we are looking forward to working together in the commercialization of SenzaGen’s high performing, accurate allergy test,” says SenzaGen CEO Anki Malmborg Hager.

Charles River Laboratories International, Inc. is a global company that specializes in a range of preclinical laboratory services for the pharmaceutical and biotechnology industries. Among its customers are many of the world’s leading pharmaceutical and biotechnology companies, academic institutions and government research centres. The company has more than 11,000 employees worldwide and is listed on the NYSE.

For more information
Anki Malmborg Hager, CEO, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telephone: +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 up to 90% reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75%. 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. For more information visit www.senzagen.com 

Press release in pdf

Positive research results for SenzaGen’s GARDpotency test published in leading scientific journal

Fri, Jun 02, 2017 08:00 CET SenzaGen announces today that a scientific evaluation of GARDpotency shows that the test reveals with high accuracy whether chemical substances are allergenic and how strong the allergic effect of the chemical is. The results have been published in the prestigious scientific journal Altex. GARDpotency is a gene-based test which […]

SenzaGen announces today that a scientific evaluation of GARDpotency shows that the test reveals with high accuracy whether chemical substances are allergenic and how strong the allergic effect of the chemical is. The results have been published in the prestigious scientific journal Altex. GARDpotency is a gene-based test which is carried out in vitro, thus eliminating the need for animal testing.

The recently published scientific evaluation has been conducted by a research group at Lund University led by Malin Lindstedt, professor and senior lecturer at the Department of Immunotechnology. The research group has been able to identify 52 biomarkers which, with very high accuracy, can quantify the allergenic effect of a chemical substance. GARDpotency is thus able to meet the challenges facing chemical manufacturers as the authorities tighten the requirements for allergy testing at the same time as regulating and prohibiting the use of the animal tests which are currently in use.

“The results of this scientific evaluation underline the fact that GARDpotency has the potential to revolutionize the testing of the chemicals we come into contact with in our daily lives. A significant advantage of GARDpotency is that it enables existing animal-based methods in regulatory testing to be replaced in line with the EU’s REACH regulation,” says SenzaGen CEO Anki Malmborg Hager.

The EU’s chemical substances regulation REACH places strict controls on the evaluation, registration and use of chemical substances. Since 2013 cosmetics may not be allergy tested on animals and, under the REACH regulation, animal-free methods must be used if available. One consequence of this is that chemicals classified as allergenic must also be potency-classified without the use of animal testing. SenzaGen has commenced a limited launch of GARDpotency and is now working to adapt the test method to the needs of industry and to achieve OECD validation.

The scientific report is available via this link:
http://www.altex.ch/resources/Zeller__of_170412_v2.pdf

For more information:
Anki Malmborg Hager, CEO SenzaGen
E-mail: amh@senzagen.com
Phone: +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. For more information visit www.senzagen.com

Press release in pdf

Positiva forskningsresultat för SenzaGens test GARDpotency publicerade i ledande vetenskaplig tidskrift

fr, jun 02, 2017 08:00 CET SenzaGen meddelar idag att en vetenskaplig utvärdering av GARDpotency visar att testet med hög träffsäkerhet avslöjar om kemiska substanser är allergiframkallande, samt hur stark kemikaliens allergiska effekt är. Resultaten har publicerats i den välrenommerade vetenskapliga tidskriften Altex. GARDpotency är ett genbaserat test som utförs i provrör, vilket eliminerar behovet […]

SenzaGen meddelar idag att en vetenskaplig utvärdering av GARDpotency visar att testet med hög träffsäkerhet avslöjar om kemiska substanser är allergiframkallande, samt hur stark kemikaliens allergiska effekt är. Resultaten har publicerats i den välrenommerade vetenskapliga tidskriften Altex. GARDpotency är ett genbaserat test som utförs i provrör, vilket eliminerar behovet av djurförsök.

Den nu publicerade vetenskapliga utvärderingen har genomförts av en forskargrupp vid Lunds universitet, under ledning av Malin Lindstedt, professor och universitetslektor vid Institutionen för Immunteknologi. Forskargruppen har kunnat identifiera 52 biomarkörer som med mycket hög träffsäkerhet kan kvantifiera den allergiframkallande effekten av en kemisk substans. GARDpotency kan därmed möta de utmaningar som kemikalieproducenter står inför, när myndigheterna skärper kraven på allergitestning och samtidigt reglerar och förbjuder användning av djurtester som används idag.
”Resultaten av den vetenskapliga utvärderingen understryker att GARDpotency har potential att revolutionera testningen av de kemikalier vi kommer i kontakt med i vardagen. En betydande fördel med GARDpotency är möjligheten att kunna ersätta befintliga djurbaserade metoder vid regulatorisk testning enligt den europeiska REACH-förordningen”, säger SenzaGens vd, Anki Malmborg Hager.

EU:s kemikalieförordning REACH ställer hårda krav på utvärdering, registrering och användning av kemiska ämnen. Sedan 2013 får kosmetika inte allergitestas på djur och under REACH-förordningen måste djurfria metoder användas om sådana finns att tillgå. Detta innebär bland annat att kemikalier vilka klassats som allergiframkallande också måste potensklassificeras, utan användning av djurförsök. SenzaGen har påbörjat lanseringen av GARDpotency i begränsad skala och arbetar nu med att få testmetoden industrianpassad och även validerad av OECD.

Den vetenskapliga rapporten finns tillgänglig via följande länk:
http://www.altex.ch/resources/Zeller__of_170412_v2.pdf

För mer information:
Anki Malmborg Hager, VD, SenzaGen AB
E-mail: amh@senzagen.com
Telefon:  0768-284822

Om GARD
GARD är provrörsbaserade tester för bedömning av kemiska hudsensibiliserare. Testerna utnyttjar genetiska biomarkörer för fler än 200 gener som täcker hela immunreaktionen och är relevanta för att förutsäga risken för överkänslighet. Testerna har en tillförlitlighet på 90%. Detta kan jämföras med den idag dominerande testmetoden, djurförsök på möss, vilken ger en tillförlitlighet på 72%. SenzaGens tester har också förmågan att mäta potensen (styrkan) av ett ämnes allergiframkallande egenskaper. GARD-testerna levererar därmed ett mer heltäckande underlag

Om SenzaGen
SenzaGen gör det möjligt att ersätta djurförsök med genetiska tester i provrör för att bedöma om de kemikalier vi kommer i kontakt med i vår vardag är allergiframkallande. Det kan till exempel handla om kosmetika, läkemedel, livsmedel och färgämnen. Bolagets patentskyddade tester är de mest tillförlitliga på marknaden och ger mer information än traditionella utvärderingsmetoder. Testerna säljs i egen regi i Sverige och USA, och genom partners i flera andra länder. De närmaste åren kommer bolaget expandera geografiskt, knyta till sig fler distributionspartners och lansera nya, unika tester. SenzaGen har sitt huvudkontor i Lund och dotterbolag i San Francisco, USA. För mer information, besök www.senzagen.com

Pressmeddelande som pdf

The GARD platform for potency assessment of skin sensitizing chemicals

ALTEX Online first published April 12, 2017, version 2 https://doi.org/10.14573/altex.1701101 Kathrin S. Zeller, Andy Forreryd, Tim Lindberg, Robin Gradin, Aakash Chawade and Malin Lindstedt, Summary Contact allergy induced by certain chemicals is a common health concern, and several alternative methods have been developed to fulfill the requirements of European legislation with regard to hazard assessment […]

ALTEX Online first published April 12, 2017, version 2 https://doi.org/10.14573/altex.1701101

Kathrin S. Zeller, Andy Forreryd, Tim Lindberg, Robin Gradin, Aakash Chawade and Malin Lindstedt,

Summary

Contact allergy induced by certain chemicals is a common health concern, and several alternative methods have been developed to fulfill the requirements of European legislation with regard to hazard assessment of potential skin sensitizers. However, validated methods, which provide information about the potency of skin sensitizers, are still lacking. The cell-based assay Genomic Allergen Rapid Detection (GARD), targeting key event 3, dendritic cell activation, of the skin sensitizer AOP, uses gene expression profiling and a machine learning approach for the prediction of chemicals as sensitizers or non-sensitizers. Based on the GARD platform, we here expanded the assay to predict three sensitizer potency classes according to the European Classification, Labelling and Packaging (CLP) Regulation, targeting categories 1A (strong), 1B (weak) and no cat (non-sensitizer). Using a random forest approach and 70 training samples, a potential biomarker signature of 52 transcripts was identified. The resulting model could predict an independent test set consisting of 18 chemicals, six from each CLP category and all previously unseen to the model, with an overall accuracy of 78%. Importantly, the model was shown to be conservative and only underestimated the class label of one chemical. Furthermore, an association of defined chemical protein reactivity with distinct biological pathways illustrates that our transcriptional approach can reveal information contributing to the understanding of underlying mechanisms in sensitization.

Link to article online