SenzaGen originally submitted the final validation report for GARDskin to the regulatory authorities in 2018, thereby fully complying with ECVAM and OECD deadlines. The report shows that GARDskin can determine with 93.8% accuracy if chemical substances pose a risk of causing allergies. This result confirms the superiority of GARDskin over all currently available validated methods. It is also the first test to include the long required potency classification in vitro, which is a requirement for registration of chemicals and also requested by customers. GARDskin is unique in that it provides a holistic view by including analysis of multiple human immunological responses in a single test. In addition, GARDskin is the first test to be validated in which biology, genomics and high-tech algorithms are combined, leading to high safety levels.
ECVAM (European Centre for the Validation of Alternative Methods) has announced that because of a high workload the evaluation of GARDskin is now scheduled for an extra meeting to be held in the spring of 2019. This in turn means that a decision by the OECD regarding the validation of GARDskin is now expected in 2020.
“SenzaGen has had a broad marketing strategy from our start and we are constantly working to expand it further. This has involved focusing the company’s resources on large markets and applications where demand for regulatory approval is limited and thus our total future revenues are only partially dependent on an OECD validation,” says SenzaGen CEO Anki Malmborg Hager.
A telephone conference is scheduled on September 19, 2018, 8:00 am CET to answer questions and further elaborate on this news. The conference will be held in Swedish.
Participant dial in numbers:
SE: +46856642662
UK: +442033645373
On the SenzaGen website, under Investors/Pressmeddelanden (http://senzagen.com/investors/pressmeddelanden/) there will be an MP3 file for those who want to listen to the conference call later, the file is available within two hours of the end of the conference call.
For more information, please contact:
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 over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. 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 http://www.senzagen.com
This information is information that SenzaGen is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out above on September 18, 2018, at 17.30.
SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com
Attached file
ECVAM evaluation of GARDskin rescheduled to an extra scientific committee meeting in spring 2019
SenzaGen originally submitted the final validation report for GARDskin to the regulatory authorities in 2018, thereby fully complying with ECVAM and OECD deadlines. The report shows that GARDskin can determine with 93.8% accuracy if chemical substances pose a risk of causing allergies. This result confirms the superiority of GARDskin over all currently available validated methods. It is also the first test to include the long required potency classification in vitro, which is a requirement for registration of chemicals and also requested by customers. GARDskin is unique in that it provides a holistic view by including analysis of multiple human immunological responses in a single test. In addition, GARDskin is the first test to be validated in which biology, genomics and high-tech algorithms are combined, leading to high safety levels.
ECVAM (European Centre for the Validation of Alternative Methods) has announced that because of a high workload the evaluation of GARDskin is now scheduled for an extra meeting to be held in the spring of 2019. This in turn means that a decision by the OECD regarding the validation of GARDskin is now expected in 2020.
“SenzaGen has had a broad marketing strategy from our start and we are constantly working to expand it further. This has involved focusing the company’s resources on large markets and applications where demand for regulatory approval is limited and thus our total future revenues are only partially dependent on an OECD validation,” says SenzaGen CEO Anki Malmborg Hager.
A telephone conference is scheduled on September 19, 2018, 8:00 am CET to answer questions and further elaborate on this news. The conference will be held in Swedish.
Participant dial in numbers:
SE: +46856642662
UK: +442033645373
On the SenzaGen website, under Investors/Pressmeddelanden (http://senzagen.com/investors/pressmeddelanden/) there will be an MP3 file for those who want to listen to the conference call later, the file is available within two hours of the end of the conference call.
For more information, please contact:
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 over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. 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 http://www.senzagen.com
This information is information that SenzaGen is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out above on September 18, 2018, at 17.30.
SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com
Attached file
ECVAMs utvärdering av GARDskin flyttad till extra möte i den vetenskapliga kommittén under våren 2019
I januari 2018 lämnade SenzaGen in den slutgiltiga valideringsrapporten för GARDskin till de regulatoriska myndigheterna helt i enlighet med ECVAM och OECD deadlines. Rapporten visar att GARDskin med en noggrannhet på 93,8% kan avgöra om kemiska ämnen riskerar att orsaka allergier. Med detta resultat överträffar GARDskin alla andra nuvarande tillgängliga validerade metoder. Det är även det första test som även inkluderar den länge efterfrågade potency klassificeringen in vitro, vilket är ett krav vid registrering av kemikalier och efterfrågat hos kunder. GARDskin är unikt genom att det ger en holistisk bild med analys av flera delar av den immunologiska reaktionen i människan i ett enda test. Dessutom är GARDskin det första test att valideras som kombinerar biologi, genomik och högteknologiska algoritmer, vilket är en av anledningarna till att testet är så säkert.
ECVAM (European Centre for the Validation of Alternative Methods) har nu meddelat att de på grund av hög arbetsbelastning först hinner behandla GARDskin i ett extrainsatt möte under våren 2019. Beskedet innebär att beslut från OECD kring valideringen av GARDskin förväntas komma under 2020.
”SenzaGen har sedan starten haft en bred marknadsstrategi och vi jobbar redan med att bredda den ytterligare, vilket innebär att bolagets samlade framtida intäkter bara delvis kommer att påverkas av OECDs validering av GARDskin. Vi har därför arbetat strategiskt och fokuserat resurser på stora marknader och applikationer där efterfrågan på regulatoriskt godkännande är begränsat”, säger Anki Malmborg Hager, vd på SenzaGen.
En telefonkonferens kommer att hållas den 19 september kl 08.00 CET för att svara på frågor om samt vidareutveckla nyheten. Telefonkonferensen kommer att hållas på svenska.
Telefonnummer för deltagande i telefonkonferensen:
SE: +46856642662
UK: +442033645373
En MP3-fil kommer att finnas tillgänglig under Investors/Pressmeddelanden (http://senzagen.com/investors/pressmeddelanden/) på SenzaGens webbplats för de som vill lyssna på telefonkonferensen i efterhand. Filen kommer att finnas tillgänglig inom två timmar efter konferensens avslutande.
För mer information, kontakta:
Anki Malmborg Hager, VD, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telefon: 0768 284822
Om GARD®
GARD® är en grupp med tester för analys av kemikaliers förmåga att starta en allergisk reaktion hos människa. Genom att analysera hundratals markörer genererar GARD® stora mängder data och levererar resultat med över 90 procents precision. Detta kan jämföras med dagens standardmetod – tester på möss – som endast uppnår 70-75 procents precision. SenzaGens test kan dessutom kvantifiera den allergiframkallande potentialen för en kemisk substans.
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 http://www.senzagen.com.
Denna information är sådan information som SenzaGen är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning och lagen om värdepappersmarknaden. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 18 september 2018 kl. 17.30
SenzaGen är listat på Nasdaq Stockholm First North (ticker: SENZA). FNCA är bolagets Certified Adviser. Mer information om SenzaGen finns att tillgå via http://www.senzagen.com.
Bifogat dokument
SenzaGen’s CEO invited to speak at EIC INNOVATORS’ SUMMIT in Berlin, September 10
SenzaGen’s CEO Anki Malmborg Hager is invited to participate and to speak at EIC Innovators’ Summit in Berlin on September 10, 2018. Anki has been selected to share her inspiring story and success as a female entrepreneur to raise awareness of Europe’s economic power of women investors and entrepreneurs. Don’t miss the workshop “Women entrepreneurs cooking up innovation” on Monday, September 10, at 4.30 PM at STATION Berlin.
Exploration of the GARD applicability domain – Skin sensitization assessment of UVCBs
Poster presented at Eurotox 2018 in collaboration with Lubrizol
Download a copy
U. I.Torstensdotter Mattson1, C. Humfrey2, O. Larne1, H. Johansson1, L. Sweet3 1SenzaGen, Lund, Sweden, 2Lubrizol, Derbyshire, United Kingdom, 3Lubrizol, Ohio, United States of America
This case study demonstrates the broadening of the applicability domain of the GARD assay when assessing UVCBs.
In this study, four test items were evaluated. All the test items were “Unknown or Variable composition, Complex reaction products and Biological materials” materials (UVCBs), which were provided by Lubrizol and selected based on existing in vivo data (internal Lubrizol data). Skin sensitizing hazard was assessed using the GARDskin assay, and the GARDpotency assay for further subcategorized the sensitizers into strong 1 A) or weak 1 B) sensitizers according to GHS/CLP classification. The GARDskin predictions for test items 1, 2, 3 and the GARDpotency classifications for test item 2 and 3 were consistent with the in vivo data, whereas test item 4 showed inconsistency between the in vitro and in vivo methods. These results indicate the importance of screening a panel of different vehicles or mixtures thereof, in order to choose the appropriate solvent For one of the Test items, the DMSO extraction procedure generates a negative prediction while the experimental vehicle mixture, Glycerol and DMF, classifies the chemical as a skin sensitizer This case study demonstrates the broadening in applicability domain of the GARDassays when assessing UVCBs.
SenzaGen hosts network meeting Understanding Biocompatibility of Medical Devices, October 2, at Medicon Village in Lund
SenzaGen is proud to be hosting the event Understanding Biocompatibility of Medical Devices on October 2, in Lund, in cooperation with the Medicon Valley Medtech Network.
The regulatory framework of the medical device industry is going through major changes and the complexity of the process is increasing due to new requirements and standards. All medical devices that come into physical contact with patients must be assessed for allergy. Therefore, manufacturers must conduct biological safety evaluations before market approval.
Learn more about biocompatibility, the legal framework and the new ISO 10993
– sign up for the event here
Date: 2nd of October, 2018
Time: 17.00- 20.00
Host: SenzaGen AB
Venue: Auditorium, Medicon Village, Lund
Program
Moderator: Rose-Marie Jenvert, Project Manager, SenzaGen AB
– meet the fellow participants
Petter Hartman, CEO, Medicon Valley Alliance
Kerstin Jakobsson, CEO, Medicon Village Innovation
Peter Borg Gaarde, Partner & European Patent Attorney, HØIBERG P/S
Monica Grekula, Business Area and Team Manager Toxicologist, Symbioteq
Carsten Senholt, Principal Toxicologist, SAXOCON
Barbara Musi, Principal Research Scientist Toxicology & Biocompatibility, Baxter
Helge Gehrke, Head of in vitro Pharmacology and Toxicology, Eurofins Biopharma Product Testing Munich
Gustav Henriksson, Head of Trade Section, trade Point Nordics, Embassy of Switzerland in Sweden
Rose-Marie Jenvert, Project Manager, SenzaGen AB
Deadline for registration is 25h of September, 2018.
More info
Kommuniké från extra bolagsstämma i SenzaGen
Extra bolagsstämma i SenzaGen AB (“SenzaGen” eller “Bolaget”) hölls idag, den 7 september 2018, varvid aktieägarna fattade följande beslut:
Val av ny styrelseledamot
Extra bolagsstämman beslutade att styrelsen ska bestå av fem ledamöter.
Vidare beslutades att ett årligt arvode till den nyvalda ledamoten ska uppgå till 100 000 kronor (det totala årliga beloppet för styrelsen är 600 000 kronor i enlighet med årsstämmans beslut).
Peter Nählstedt valdes till ny styrelseledamot.
För mer information om Peter Nählstedt och befintliga styrelseledamöter hänvisas till kallelsen respektive information som finns tillgängligt på Bolagets hemsida, http://www.senzagen.com.
För mer information, kontakta:
Anki Malmborg Hager, VD, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telefon: 0768 284822
Om GARD®
GARD® är en grupp med tester för analys av kemikaliers förmåga att starta en allergisk reaktion hos människa. Genom att analysera hundratals markörer genererar GARD® stora mängder data och levererar resultat med över 90 procents precision. Detta kan jämföras med dagens standardmetod – tester på möss – som endast uppnår 70-75 procents precision. SenzaGens test kan dessutom kvantifiera den allergiframkallande potentialen för en kemisk substans.
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 http://www.senzagen.com.
Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 7 september 2018, kl. 08:50.
SenzaGen är listat på Nasdaq Stockholm First North (ticker: SENZA). FNCA är bolagets Certified Adviser. Mer information om SenzaGen finns att tillgå via http://www.senzagen.com.
Bifogat dokument
Extended applicability domain with new solvent selection for the GARD platform
Jenvert RM, Larne O, Torstensdotter MattssonU. I., Johansson H, SenzaGen, Lund, Sweden
Introduction
The Genomic Allergen Rapid Detection (GARD) assay is a state of the art in vitro assay developed for the assessment of skin sensitizers. It is based on gene expression analysis of SenzaCells, a human myeloid cell line, after stimulation by the test item.
During the development of the GARD platform, two solvents were used; DMSO (0.1%) and Water. To increase the applicability domain of GARD® and the solubility of certain test items, for e.g. Medical Device extracts and UVCBs, we here show a broader range of solvents compatible with GARD.
Conclusions
Here, we show that the GARD® platform is compatible with the following solvents:
• Acetone
• Ethanol
• Glycerol
• Super refined olive oil
• DMF
• DMSO
• Water
• Isopropanol
Poster download
Exploration of the GARD® applicability domain – Sensitization assessment of UVCBs
Joint poster presented at Eurotox 2018
U. I. Torstensdotter Mattson, C. Humfrey, O. Larne, H. Johansson, L. Sweet
SenzaGen, Lund, Sweden, Lubrizol, Derbyshire, United Kingdom, Lubrizol, Ohio, United States of America
Introduction
The GARD – Genomic Allergen Rapid Detection – platform is a state of the art in vitro assay for assessment of chemical sensitizers. The GARD®skin assay is a powerful tool for assessment of chemical sensitizers, with a predictive accuracy of 94%. In this study, four UVCB test items, provided by Lubrizol and selected based on existing in vivo data (internal Lubrizol data), were evaluated. Sensitizing hazard was assessed using the GARD®skin assay, and the GARD®potency assay further subcategorized the sensitizers into strong (1A) or weak (1B) sensitizers according to GHS/CLP classification. Here we show the importance of using appropriate vehicles in order to predict a correct classification of Test items.
Conclusion
A UVCB Test item with poor water and DMSO solubility was assessed using a mixture of vehicles with different polarity indexes (DMF and Glycerol 1:1). This experimental vehicle mixture classified the UVCB as a skin sensitizer, being consistent with the in vivo data. This case study demonstrates the broadening of the applicability domain of the GARD -assay when assessing UVCBs.
Poster dowload
The Validation of GARD™skin and GARD™potency
Poster presented at Eurotox, 2018
Sandberg P, Johansson A, Agemark M, Gradin R, Larne O, Appelgren H, Forreryd A, Jerre A, Edwards A, Hoepflinger V, Burleson F, Gehrke H, Roggen E, Johansson H
SenzaGen, Lund, Sweden, Burleson Research Technologies, Morrisville, US, Eurofins, Munich, Germany
Introduction
The prevalence of allergic contact dermatitis (ACD) is estimated to >20% in the western world. Not only the individual is affected, but downstream socioeconomic effects are high. To minimize exposure, chemicals must be safety tested. Traditional testing strategies like the murine local lymph node assay (LLNA) comprise animals, but the regulatory authorities, public opinion and economic interests require animal-free models. The Genomic Allergen Rapid Detection skin (GARD®skin) is an in vitro assay addressing this need. Here, we present the results of the GARD®skin ring trial (OECD TGP 4.106) for validity of the assay. In addition, we show data for GARD®potency – a complementary assay developed to categorize identified senitizers as CLP 1A or 1B.
Conclusions
Transfer study
Transferability: 100%
Validation study
Reproducibility
WLR: 82 – 89%BLR: 92% (92 – 100%)
Test performance
– Accuracy: 94%
– Sensitivity: 93%
– Specificity: 96%
A blinded ring trial was performed to assess the functionality of the GARDskin assay. The data demonstrates that GARDskin is a powerful tool for assessment of chemical skin sensitizers, with a predictive accuracy of 94% and excellent reproducibility between laboratories.
In addition, we show that GARDpotency accurately assesses potency of identified sensitizers.
Poster download
Predicting skin sensitizers with confidence – Using conformal prediction to determine applicability domain
Objective
GARD – Genomic Allergen Rapid Detection – is a state of the art non-animal based technology platform for classification of skin sensitizing chemicals. The assay has proven to be reliable and highly accurate for identification of skin sensitizing chemicals, and consistently reports predictive performances > 90% across external test sets. The aim of the current project is to complement assessments of average model performance with an estimate of uncertainty involved in each individual prediction, thus allowing for classification of skin sensitizers with confidence.
Results
An Internal validation procedure was initially performed on samples in the GARD training set (n=38) using the strategy described in Fig. 3A. Results from this exercise is summarized in Fig. 4A. Conformal prediction by definition allows the user to determine a reasonable and acceptable significance level to guarantee a maximum error rate in predictions. The significance level was set to 15%, i.e. the model was allowed to make a maximum of 15% errors. Performance of the conformal predictor was measured by validity and efficiency. A model was valid if the number of prediction errors did not exceed the significance level, while efficiency corresponded to the percentage of single class predictions. Internal validation of the training data resulted in a valid and highly effective model (92% single classifications, 1 empty, 2 both), indicating that the ambitious significance level was at a reasonable level for the GARD® assay. Following internal validation, samples in a large external test set (n =70) was classified within the CP framework as described in Fig. 3B, which resulted in generation of a valid and highly efficient model (99% single classifications, 0 empty, 1 both) (Fig.4B). Additional data on model performance is illustrated in Table 1.
Poster download