SenzaGens slutgiltiga valideringsrapport för GARDskin™ inlämnad till regulatoriska myndigheter – visar på den högsta träffsäkerheten på marknaden

Lund, 12 januari 2018 – SenzaGen (Nasdaq First North: SENZA) meddelar idag att bolaget har lämnat in den officiella valideringsrapporten för GARDskin till berörd regulatorisk myndighet. Ett globalt godkännande och rekommendation från ECVAM och OECD om användningen av GARDskin förväntas i april 2019. De slutliga resultat som presenteras i rapporten visar att testet med en noggrannhet på 93,8% kan avgöra om kemiska ämnen riskerar att orsaka allergier. Detta bevisar att GARDskin överträffar alla nuvarande tillgängliga validerade metoder.

 

Analysen av data har i enlighet med valideringskraven utförts av en oberoende statistiker. Analysen ligger till grund för den officiella rapport som lämnats in till ECVAM. Rapporten visar att testets träffsäkerhet är mycket hög och når en noggrannhet på 93,8% (medelvärde) för alla tre oberoende laboratorier som ingick i utvärderingen, (Eurofins BioPharma Product Testing i Tyskland, Burlesons Research Technologies i USA och SenzaGens eget laboratorium i Lund).

Valideringen har inkluderat ett stort antal kodade kemikalier vars identitet tillika hållits okända för valideringslaboratorierna. Detta för att möjliggöra den blindade utvärdering som krävs i denna process. Samtliga resultat har i kodat format rapporterats in från de olika laboratorierna till den externa valideringsstatistiker som därefter avkodat kemikaliernas identitet, för att jämföra GARDs klassificeringsresultat från de tre oberoende laboratorierna. Statistikerns uppgift har varit att jämföra resultatenen från samtliga laboratorier. Detta har möjliggjort en analys av träffsäkerheten för GARD i att klassificera kemikalier som icke-sensibiliserande eller sensibiliserande. Förutom resultaten rörande träffsäkerheten innehåller valideringsrapporten även omfattande data om testplattformens robusthet och testets överförbarhet.

Resultaten i valideringsrapporten utgör grunden för utvärderingen av SenzaGens tester i ECVAM:s Vetenskapliga Kommitté och inom OECD inför regulatoriskt godkännande, samt utformningen av rekommendation och riktlinjer för användning av GARDskin vid säkerhetstestning av kemikalier. Det slutgiltiga regulatoriska beslutet från OECD förväntas i april 2019. GARDpotency™, som bygger på samma biologiska plattform, valideras parallellt med GARDskin och förväntas därför godkännas och rekommenderas samtidigt.

“Dessa utmärkta valideringsresultat understryker GARD-testernas potential att revolutionera djurfria allergitester. Vi har länge varit medvetna om testets höga prestanda, och den validering som nu genomförts vid oberoende laboratorier är förstås mycket tillfredställande och ytterst betydelsefull. Det förtjänar att poängteras att valideringen dessutom har bekräftat hur enkelt analysen kan överföras till andra laboratorier. Detta bidrar till stort förtroendet för GARD hos de laboratorier runt om i världen som kommer att implementera vår unika analysmetod”, säger Anki Malmborg Hager, vd, SenzaGen.

Det fullständiga resultatet av valideringen kommer att presenteras vid Society of Toxicologys 57:e årliga möte den 11–15 mars i San Antonio, USA.

  

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
Med sin teknologiplattform GARD gör SenzaGen 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 är noterat på Nasdaq First North (SENZA), och har sitt huvudkontor i Lund och dotterbolag i San Francisco, USA. För mer information, besök www.senzagen.com.

 

Informationen lämnades genom ovanstående kontaktpersons försorg för offentliggörande den 12 januari 2018 klockan 08:45.

SenzaGen är listat på Nasdaq Stockholm First North (ticker: SENZA). FNCA är bolagets Certified Adviser. Mer information om SenzaGen finns på  http://www.senzagen.com.

SenzaGen’s final validation report of GARDskin™ submitted to regulatory authorities – reveals highest test prediction accuracy in the field

Lund, January 12, 2018 – SenzaGen (Nasdaq First North: SENZA) announces today that the company has submitted the final report for the validation of GARDskin™ to the regulatory authorities. Global regulatory approval and recommendation by ECVAM and OECD on the use of GARDskin is expected in April 2019. The final result presented in the report shows an unprecedented over all prediction accuracy of 93,8% in determining whether chemical substances are at risk of causing allergies. This proves that GARDskin™ outperforms all current available validated methods.

 

The analysis of the data has been performed by an independent validation statistics consultant, according to the regulatory requirements. This analysis is the base for the official report now sent in to ECVAM. The data shows that the mean accuracy from all three independent laboratories (Eurofins BioPharma Product Testing in Germany, Burleson’s Research Technologies in the United States and SenzaGen’s own laboratory in Lund) is very high, reaching an accuracy of 93,8%.

The validation has included a large number of coded chemicals unknown to the validation laboratories, to enable the blinded testing demanded in this process. All laboratory results have been provided in a blinded manner to an external validating statistics consultant, who has now decoded the identity of the chemicals to compare the GARD classification performed at each lab, and analysed the prediction accuracy of GARD in classifying compounds as non-sensitizers or sensitizers. The validation report also includes data on the robustness of the test platform and its transferability.

The results in this report constitutes the basis for the evaluation of SenzaGen’s tests in the ECVAM Scientific Committee and within the OECD for regulatory approval and Test Guideline recommendation on the use of GARDskin. The regulatory decision from OECD is expected in April 2019. GARDpotency™, which is based on the same biological platform, is being validated in parallel with GARDskin™, and is thus expected to be approved and recommended at the same time.

“These excellent validation results underpin the potential for GARD testing to become a game changer in in vitro allergy testing. We have long been aware of its high performance, and the validation now also provided by independent laboratories is of course very satisfying. Importantly, the validation has highlighted the simplicity of assay transfers to other labs. This adds to the confidence of further laboratories around the world to set up our unique assay,” says Anki Malmborg Hager, CEO of SenzaGen.

A comprehensive report of the results will be presented at the Society of Toxicology’s 57th Annual Meeting 11-15 March in San Antonio, US.

 

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

 

The information was provided by the contact person for publication on 12 January 2018 at 08:45.

SenzaGen AB are listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit www.senzagen.com

Malin Lindstedt, founder of SenzaGen and GARD, is awarded the NYTÄNKAREN 2017 (INNOVATIVE THINKER 2017) prize by the Swedish foundation Research Without Animal Experiments

SenzaGen’s co-founder, Professor Malin Lindstedt, has been awarded the Nytänkaren 2017 (Innovative Thinker 2017) Prize and SEK 400,000 by the Swedish fundation for Research Without Animal Experiments for her work on the development of animal-free testing methods. The prize was awarded today, 16 October at a ceremony at Research Without Animal Experiments offices in Stockholm.

Professor Malin Lindstedt receives the prize for her successful development of advanced testing methods that can reduce and replace the use of animals in the risk assessment of chemicals and consumer products. Malin Lindstedt works at Lund University’s Department of Immunotechnology, where she has directed the research that lies behind the series of allergy tests based on cell-based gene analysis that are now marketed under the name GARD. Under her direction, a research team started by developing a test for skin allergies. They then went on to develop a test to determine which substances can cause respiratory allergies, and most recently a test that can analyze proteins associated with food allergies.

While working on the development of the technology behind GARD, Malin Lindstedt founded SenzaGen, the company which is now responsible for making this technology available on the global market. The first test to be developed, GARDskin, is already seeing limited use. GARDskin is at the present time undergoing a validation process for inclusion in the OECD Chemical Test Guidelines, which would result in the method achieving its international breakthrough as an eligible method that meets regulatory requirements for the risk assessment of chemicals.

The prize from Research Without Animal Experiments highlights the practicability of using advanced methods to continue to reduce and replace the use of animals in the risk assessment of chemicals and consumer products both inside and outside Sweden. With the NYTÄNKAREN prize and its associated funding, Research Without Animal Experiments wishes particularly to support the research team’s ambitions to continue their development of allergy tests.

 

News about the prize can be viewed on the Research Without Animal  Experiments website:

http://forskautandjurforsok.se/knappar-pa-startsidan/nytankaren-2017/

 

For more information

Anki Malmborg Hager, CEO, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telephone: +46 768 284822

All laboratory elements completed in the regulatory part of the validation process for SenzaGen’s GARDskin allergy test

Lund, 6th October, 2017. SenzaGen (Nasdaq First North: SENZA) announces today that all laboratory elements in the validation of GARDskin have been completed according to plan. After data processing and statistical analysis, the results will be compiled and reported to the international regulatory authorities ECVAM and OECD. The results of the analysis will also be published in conjunction with the submission of this report.

The purpose of this final step of the validation process is to document reproducibility in the use of GARDskin. Three laboratories (Eurofins in Germany, Burleson’s Research Technologies in the USA and Senzagen’s own laboratory) have independently carried out tests of 28 coded chemicals on three separate occasions, and this work has now been completed.

The validation element for reproducibility follows evaluations demonstrating that GARDskin can be set up in laboratories other than SenzaGen’s own (transferability). The results of these evaluations were published at the European Toxicology Conference EuroTox in Bratislava in September 2017, showing 100% transferability.

“Every step in the validation process brings us closer to our goal of establishing GARD as the new global industry standard for animal-free toxicological testing and as the natural choice for screening new drug candidates to make it possible at an early stage to weed out substances that are harmful and will not be usable as medicines,” says SenzaGen’s CEO, Anki Malmborg Hager.

After all the results from the different stages of the validation process have been compiled and reported, an assessment will take place in the ECVAM Scientific Committee and within the OECD. Regulatory approval and the OECD’s recommendations concerning the use of GARDskin are expected in April 2019. GARDpotency, which is based on the same biological platform, is to be evaluated in parallel with GARDskin, and is thus expected to be approved and recommended at the same time.

 

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 

The information was provided by the contact person for publication on October 6 at 11:30.

SenzaGen is presenting at hosted session at the EUROTOX Congress in Bratislava

SenzaGen new Chief Scientific officer Hernik Appelgren will give a presentation on 21st century testing for skin sensitisation and updates on application of the GARD platform at The 53rd  European Congress of the European Societies of Toxicology, EUROTOX, on the 12th of Sept. SenzaGen is also Exhibiting at the congress and presenting two posters

The meeting promises scientific sessions houndreds of abstract presentations, exhibitors meetings, continuing education courses, awards presentations, receptions,  and  an exhibition area for exhibitors offering you the latest information on services and technology
Presentation details
Tuesday 12 Sep 10-11 AM | 
Memories, Hotel Sheraton
21st Century Sensitisation testing: Can one test be stand alone? Regulatory challenges and GARD applications update
.

Presented by: Henrik Appelgren, Chief Scientific Officer and regulatory expert at SenzaGen

Allergy is a growing health problem in humans. The data requirements for the assessment of sensitisation in chemical legislations have been based on animal assays, which until now have served as the golden standard. However, in vitro assays have been developed which need to be combined in order to address all key events for sensitisation to fulfil the demands in e. g., Reach. However, The Genomic Allergen Rapid Detection Skin (GARDskin) assay addresses all the key regulatory questions regarding sensitisation, including potency – How? This session we will give an update on the validation status and the different applications of GARD.

Posters
ID 668 | Session 2 | Board no P-04-02-07 | Monday, Sept 11 from 15:00
Transferability of the GARDskin assay to two independent laboratories.

ID 438 | Session 4 | Board number P-09-02-31 | Tuesday, Sept 12 from 15:00
The GARD platform for potency assessment of skin sensitizing chemicals

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 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

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 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

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
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

senzagen gard session

SenzaGen is presenting at hosted sessions at Society of Toxicology 56th Annual Meeting in Baltimore March 12-16, 2017

Lund University Scientist Andy Forreryd and SenzaGen CEO Anki Malmborg Hager will give a presentatios about the GARD assay at exhibitor hosted sessions at the Society of Toxicology 56th Annual Meeting in Baltimore, on the 13th and 14th of March.

The meeting promises more than 150 scientific sessions, approximately 350 ToxExpo exhibitors offering you the latest information on services and technology, thousands of abstract presentations, continuing education courses, awards presentations, receptions, career guidance and support, and more.

Presentations details

– Replacement of Animal Testing for CLP/GHS Classification of Skin Sensitizers is now possible using a Modified Genomic GARDskin [OECD TGP 4.106] Assay
SenzaGen presents the latest development towards reliable potency classification of chemicals according to CLP 1A and 1B, taking both LLNA and Human potency data in consideration. The assay is based on GARDskin and utilizes a refined gene expression signature developed specifically for potency categorization with high predictability.

Date: 3/13 Time: 13:30 -14:30  Room: 338

– Advantages with Genome Testing Opening up the Landscape for New Application Possibilities for Sensitization Testing using SenzaGen’s Genomic GARD Assay
SenzaGen’s GARD assay is based on expression analysis of predictive genomic biomarker signatures. Prediction calls of test substances are generated by computational methods based on machine learning. SenzaGen presents their experience in skin and respiratory sensitization testing, working with challenging compounds and mixtures, active substances, potency classification and NOEL interpretation.

Date: 3/14 Time: 13:30-14:30  Room: 338

These session are Exhibitor-Hosted Session. Although not an official part of the SOT Annual Meeting scientific program, its presentation is permitted by the Society.

Attendees are welcomed from researcher community, industry, manufacturers, regulatory agencies, consultants, CROs and every one interested in safety testing of chemical compounds.

Evaluation of the GARD assay in a blind Cosmetics Europe study

ALTEX Online first published February 17, 2017 https://doi.org/10.14573/altex.1701121

Johansson H., Gradin R., Forreryd A., Agemark M., Zeller K., Johansson A., Larne O., van Vliet E.,  Borrebaeck C., Lindstedt M.,

Summary

Chemical hypersensitivity is an immunological response towards foreign substances, commonly referred to as sensitizers, which gives rise primarily to the clinical symptoms known as allergic contact dermatitis. For the purpose of mitigating risks associated with consumer products, chemicals are screened for sensitizing effects. Historically, such predictive screenings have been performed using animal models. However, due to industrial and regulatory demand, animal models for the purpose of sensitization assessment are being replaced by animalfree testing methods, a global trend that is spreading across industries and market segments. To meet this demand, the Genomic Allergen Rapid Detection (GARD) assay was developed. GARD is a novel, cell-based assay that utilizes the innate recognition of xenobiotic substances by dendritic cells, as measured by a multivariate readout of genomic biomarkers. Following cellular stimulation, chemicals are classified as sensitizers or non-sensitizers based on induced transcriptional profiles. Recently, a number of animal-free methods were comparatively evaluated by Cosmetic Europe, using a coherent and blinded test panel of reference chemicals with human and local lymph node assay data, comprising a wide range of sensitizers and non-sensitizers. In this paper, the outcome of the GARD assay is presented. It was demonstrated that GARD is a highly functional assay with a predictive performance of 83% in this Cosmetics Europe dataset. The average accumulated predictive accuracy of GARD across independent datasets was 86%, for skin sensitization hazard. Keywords: GARD, sensitization, in vitro, predictive accuracy, alternative methods

Link to article e-pub ahead of print