SenzaGen’s presentation at Unicorn Summit

On October 10, SenzaGen participated in the Vator Securities Unicorn Summit, a capital market day organized to bring together some of the most innovative and fast-growing Swedish life science companies with investors. Anki Malmborg Hager presented Senzagen’s developments and accelerated efforts towards further strengthening the commercial organization and the global presence of GARD®, a group of tests for animal-free safety testing. […]
On October 10, SenzaGen participated in the Vator Securities Unicorn Summit, a capital market day organized to bring together some of the most innovative and fast-growing Swedish life science companies with investors.
Anki Malmborg Hager presented Senzagen’s developments and accelerated efforts towards further strengthening the commercial organization and the global presence of GARD®, a group of tests for animal-free safety testing. You will find Anki’s full presentation here

SenzaGen presenterar vid Vator Securities Unicorn Summit 10 oktober 2018 from Vator Securities on Vimeo.

Anki Malmborg Hager interviewed by EFN (in Swedish)

On October 15, SenzaGen’s CEO Anki Malmborg Hager was interviewed by Swedish financial media EFN about SenzaGen’s cruelty-free test platform GARD®, our business model and new sales targets. The result was a short and to-the-point interview about our core business and our future. You will find the filmed interview (in Swedish) here: https://www.efn.se/bors-finans/senzagen-ersatter-djurforsok-kemikalietester/
On October 15, SenzaGen’s CEO Anki Malmborg Hager was interviewed by Swedish financial media EFN about SenzaGen’s cruelty-free test platform GARD®, our business model and new sales targets. The result was a short and to-the-point interview about our core business and our future. You will find the filmed interview (in Swedish) here:

GARDair – A novel assay for assessment of chemical respiratory sensitizers based on a genomic platform

Henrik Johansson, Andy Forreryd, Robin Gradin, Angelica Johansson, Olivia Larne, Emil Aaltonen, Anders Jerre, Carl A.K. Borrebaeck and Malin Lindstedt SenzaGen AB, Lund, Sweden. Department of Immunotechnology, Lund, Sweden. Introduction Exposure to chemicals may induce allergic hypersensitivity reactions in skin or respiratory tract. To minimize exposure, chemicals are routinely screened for their sensitizing potential. Proactive […]
Henrik Johansson, Andy Forreryd, Robin Gradin, Angelica Johansson, Olivia Larne, Emil Aaltonen, Anders Jerre, Carl A.K. Borrebaeck and Malin Lindstedt
SenzaGen AB, Lund, Sweden. Department of Immunotechnology, Lund, Sweden.

Introduction
Exposure to chemicals may induce allergic hypersensitivity reactions in skin or respiratory tract. To minimize exposure, chemicals are routinely screened for their sensitizing potential. Proactive identification has historically been performed using animal models, but the use of animals for safety assessment of cosmetics was recently banned within EU. Today, similar trends are spreading both globally and across industry and market segments. Methods for specific identification of respiratory sensitizers are greatly underdeveloped, with no validated, or even widely used assay readily available. Thus, there is an urgent need for development of non-animal-based methods for hazard classification of respiratory sensitizing chemicals.

GARD– Genomic Allergen Rapid Detection – is a state of the art technology platform for assessment of chemical sensitizers (Figure 1). It is based on a dendritic cell (DC)-like cell line, thus mimicking the cell type involved in the initiation of the response leading to sensitization. Following test chemical exposure, induced transcriptional changes are measured to study the activation state of the cells. These changes are associated with the immunological decision-making role of DCs in vivo and constitutes of e.g. up-regulation of co-stimulatory molecules, induction of cellular and oxidative stress pathways and an altered phenotype associated with recognition of xenobiotic matter. By using state-of-the-art gene expression technologies, high informational content data is generated, that allows the user to get a holistic view of the cellular response induced by the test substance.

Conclusion
GARDair is a novel assay for assessment of respiratory sensitizers. It is an adaptation of the GARD platform, utilizing gene expression analysis of predictive biomarker signatures and state-of-the-art data analysis methodology. GARDair has been proven functional and is currently progressing towards industrial implementation and  regulatory acceptance with financial support from the EU programme Horizon 2020. This progress includes scientific verification of results, assay optimization, assay
transfer and formal validation by a blinded ring trial.

Link to poster

A mechanistic reinterpretation of the AOP for skin sensitisation

David W Roberts, Liverpool John Moores University, Liverpool Introduction – Non-Animal Prediction: the 21st Century Consensus Because of the biological complexity of the skin sensitisation process no single in chemico or in vitro assay will be an appropriate replacement for an animal-based assay such as LLNA or GPMT… …to ensure a mechanistic basis and cover the […]

David W Roberts, Liverpool John Moores University, Liverpool

Introduction – Non-Animal Prediction: the 21st Century Consensus
Because of the biological complexity of the skin sensitisation process no single in chemico or in vitro assay will be an appropriate replacement for an animal-based assay such as LLNA or GPMT…
…to ensure a mechanistic basis and cover the complexity, multiple methods should be integrated into a testing strategy, in accordance with the adverse outcome pathway that describes all key events in skin sensitisation.

We need an ITS based on the KEs of the AOP…but
Is that what we really need?

Conclusion

A single assay, GARD™, predicts sensitisation potential and absence of sensitisation potential better than any of, or combinations of, the OECD guideline assays DPRA, KeratinosensTM (ARE-Nrf2 ) and h-CLAT.

We do not really need an ITS covering all KE’s of the AOP.

Link to poster

blue senzagen logo

Senzagen strengthens US organisation and commercial presence with aim to enroll more licensees

Lund, October 11, 2018 - SenzaGen (Nasdaq First North: SENZA) today announces that the Company is strengthening its presence in the important US market through a major strategic recruitment. The recruitment of Dr. Joshua J. Schmidt as Business Development Director at SenzaGen Inc represents a further expansion of the Company's commercial organization and an increasing focus on establishing collaborations with both licensees and distributors, in accordance with SenzaGen’s recently communicated financial targets. In parallel with the recruitment, SenzaGen Inc also becomes a wholly-owned subsidiary, offering additional possibilities for steering the commercial strategy in the US.

SenzaGen is focusing on the chemical, cosmetics, pharmaceutical and medical device markets for global commercialization of the in vitro platform GARD®.

In 2017 and 2018, SenzaGen has gradually strengthened its commercial organisation and global presence through new agreements with strategic partners. The background to the recruitment in the US is that SenzaGen intends to accelerate its collaborations with both US licensees and industrial partners for the development of the GARD®portfolio.

“The US is a priority market, and through the recruitment of Joshua J. Schmidt, we are strengthening our organisation by adding significant network, knowledge and insight into the US market, which contributes to achieving our financial targets,” says Anki Malmborg Hager, CEO of SenzaGen

Joshua J. Schmidt has extensive business and scientific experience from 3M, Medtronic and Bruker Daltonics, most recently as Senior Account Executive for a US-based CRO, Pace Analytical Life Sciences, where he worked with testing of pharmaceutical products and medical devices in the US.

“SenzaGen’s technology is impressive and has true potential to significantly and positively impact the chemical and life science industries. I am excited to join SenzaGen at this time because I see great opportunity and potential for growth in the US and globally for GARD®”, says Joshua J. Schmidt, Business Development Director at SenzaGen Inc.

In conjunction with Joshua J. Schmidt’s appointment as Business Development Director, SenzaGen Inc becomes a wholly-owned subsidiary of SenzaGen AB (publ).

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 Delaware 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 October 11, 2018, at 08.30.

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

blue senzagen logo

SenzaGen stärker organisationen i USA med målsättningen att öka den kommersiella närvaron genom att öka antalet licenstagare

Lund, den 11 oktober 2018 – SenzaGen (Nasdaq First North: SENZA) meddelar idag att Bolaget genom en strategisk rekrytering förstärker sin närvaro på den viktiga amerikanska marknaden. Rekryteringen av Dr. Joshua J. Schmidt som Business Development Director på SenzaGen Inc innebär ytterligare en expansion av Bolagets kommersiella organisation och fokus på att etablera samarbeten med såväl licenstagare som distributörer i enlighet med SenzaGens nyligen kommunicerade finansiella målsättning. I samband med rekryteringen omorganiseras också SenzaGen Inc till ett helägt dotterbolag, vilket ger ytterligare möjligheter att styra den kommersiella strategin i USA.

SenzaGen fokuserar på kemikalie-, kosmetika-, läkemedels- och medicintekniska marknaderna för sin globala kommersialisering av in vitro-plattformen GARD®.

Under 2017 och 2018 har SenzaGen successivt stärkt sin kommersiella organisation och globala närvaro med nya avtal med strategiska partners. Bakgrunden till nyrekryteringen i USA är att SenzaGen avser att accelerera samarbetena både med amerikanska licenstagare och med industriella partners för utveckling av GARD®-portföljen.

“USA är en prioriterad marknad och genom rekryteringen av Joshua J. Schmidt förstärker vi vår organisation med ett betydande nätverk, kunskap och insikter om den amerikanska marknaden vilket medverkar till att vi når vår finansiella målsättning”, säger Anki Malmborg Hager, VD på SenzaGen

Joshua J. Schmidt har omfattande affärs- och vetenskaplig erfarenhet från 3M, Medtronic and Bruker Daltonics, senast som Senior Account Executive för en amerikanska CRO, Pace Analytical Life Sciences, där han arbetat med testning av farmaceutiska och medicinsktekniska produkter i USA.

“SenzaGens teknologi imponerar och har verkligen potential att väsentligt påverka kemikalie- och life science-industrin på ett positivt sätt. Jag är entusiastisk över att komma in i SenzaGen i detta skede eftersom jag ser stora möjligheter och potential för tillväxt, såväl i USA som globalt för GARD®”, säger Joshua J. Schmidt, Business Development Director på SenzaGen Inc.

I samband med att Joshua J. Schmidt utses till Business Development Director blir SenzaGen Inc ett helägt dotterbolag till SenzaGen AB (publ).

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 Delaware, 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 11 oktober 2018 kl. 08:30.

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 presenting at Vator Securities Unicorn Summit on October 10, 2018

SenzaGen will participate in the Vator Securities Unicorn Summit, which takes place today, October 10, at Medicon Village in Lund. Anki Malmborg Hager will present Senzagen´s developments and accelerated efforts towards further strengthening the commercial organization and the global presence of SenzaGen’s platform GARD®, a group of tests for animal-free safety testing. Unicorn Summit is a capital market day organized by Vator Securities to bring together some […]

SenzaGen will participate in the Vator Securities Unicorn Summit, which takes place today, October 10, at Medicon Village in Lund. Anki Malmborg Hager will present Senzagen´s developments and accelerated efforts towards further strengthening the commercial organization and the global presence of SenzaGen’s platform GARD®, a group of tests for animal-free safety testing.

Unicorn Summit is a capital market day organized by Vator Securities to bring together some of the most innovative and fast-growing Swedish life science companies with investors. More information about Vator Securities www.vatorsecurities.se

blue senzagen logo

Senzagen presents financial targets

Lund, October 9, 2018 – The SenzaGen Board of Directors (Nasdaq First North: SENZA) announces today that it has adopted financial targets. The underlying reasons behind this decision are the successful development in-house of a broad and unique product portfolio, the growing number of partnerships being established with CROs and other industrial partners, and the identification of larger target markers which will entail entering long term contracts with major new CRO partners. Thus, SenzaGen is now considerably expanding its focus on building and strengthening its existing commercial organization.

SenzaGen focuses on the chemical, cosmetics, pharmaceutical and medical device markets for the global commercialization of the in vitro platform GARD®. In 2017 and 2018, SenzaGen has gradually strengthened its commercial organization and global presence with new agreements with strategic partners. The efforts are now accelerating with both more CRO partnerships and more collaborations with industrial partners for the company’s broad product pipeline. In the autumn, SenzaGen announced that the company will also target its sales efforts towards the growing medical device market. In addition, SenzaGen has recently launched another test based on its platform, GARDair, the first in vitro test for airway allergies. 

The new financial goals being adopted are:

  • To achieve a turnover of MSEK 300 in 2023 with sustainable sales growth exceeding 30% and a sustainable gross margin exceeding 50% for the years to follow.
  • To reach break-even in 2021 with a turnover of 80 MSEK. 

“There are a number of factors that indicate strong and sustainable future sales growth. The interest and demand for animal-free tests is strong and keeps growing as new regulations reduce the possibility of using technically and ethically substandard animal tests. We will sustain our pace of product development to meet the biggest and most urgent challenges that the different industries face. We are in the forefront of the field and we are now broadening our strategy by putting a strong focus on recruiting strong CRO and industrial partners in all our market segments and geographies,” says Anki Malmborg Hager, CEO of SenzaGen.

SenzaGen’s financial targets set forth above constitute forward-looking information and are based on a number of assumptions about the operating environment in which the Company operates. This may vary significantly and be inferior to SenzaGen’s assessments when the financial targets were adopted. As a consequence, SenzaGen’s ability to achieve the financial targets will depend on uncertainties and contingencies, some of which are outside the Company’s control. There is no guarantee that SenzaGen can achieve the targets or that the Company’s financial position or operating profit will not differ significantly from the financial targets.

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, 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 October 9, 2018, at 08.30.

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

blue senzagen logo

SenzaGen presenterar finansiell målsättning

Lund, den 9 oktober 2018 – Styrelsen i SenzaGen (Nasdaq First North: SENZA) har idag antagit en finansiell målsättning med anledning av att Bolaget nu har utvecklat en bred och unik produktportfölj, etablerat CRO- och industriella partners samt identifierade målmarknader med nya, större CRO-partners som löpande kontrakteras. SenzaGen övergår därför nu till att med väsentligt större fokus bygga ut och kraftigt förstärka Bolagets befintliga kommersiella organisation.

SenzaGen fokuserar på kemikalie-, kosmetika-, läkemedels- och medicintekniska marknaderna för sin globala kommersialisering av in vitro-plattformen GARD®. Under 2017 och 2018 har SenzaGen successivt stärkt sin kommersiella organisation och globala närvaro med nya avtal med strategiska partners. Arbetet accelererar nu med fler samarbeten med CRO-partners samt att utveckla fler samarbeten med industriella partners för bolagets produktpipeline. Under hösten har SenzaGen kommunicerat att Bolaget även kommer att rikta sina försäljningsinsatser mot den växande medicintekniska marknaden. Dessutom har SenzaGen nyligen lanserat ytterligare ett test i sin plattform, GARDair, som är det första in vitro-testet för luftvägsallergier.  

Följande finansiella målsättning har idag antagits:

  • SenzaGens målsättning är att nå en omsättning om 300 MSEK år 2023 med en hållbar försäljningstillväxt överstigande 30% och en långsiktigt hållbar bruttomarginal överstigande 50% för efterföljande år.
  • Bolaget förväntar sig att nå break-even 2021 med en omsättning om 80 MSEK. 

“Det finns en rad faktorer som talar för en stark och hållbar försäljningstillväxt framöver. Intresset och efterfrågan på djurfria tester är stort och växer i takt med att nya regelverk stryper möjligheten att använda tekniskt och etiskt undermåliga djurtester. Vi kommer att fortsätta hålla produktutvecklingstakten baserat på de största och mest akuta utmaningarna som de olika industrierna måste ha en lösning på. Vi ligger mycket långt fram och vi breddar därför vår strategi nu och fokuserar kraftfullt på att rekrytera starka CRO- och industriella partners inom alla våra marknadssegment och geografier”, säger Anki Malmborg Hager, VD på SenzaGen.

SenzaGens finansiella målsättning som anges ovan utgör framåtblickande information och grundas på ett antal antaganden om den verksamhetsmiljö som

Bolaget är verksamt i vilken över tid kan variera väsentligt och bli sämre än vad SenzaGen bedömde när den finansiella målsättningen antogs. Som en följd därav omfattas SenzaGens förmåga att uppnå den finansiella målsättningen av osäkerheter och eventualiteter, varav vissa är utanför Bolagets kontroll. Det finns ingen garanti för att SenzaGen kan nå målsättningen eller att Bolagets finansiella ställning eller rörelseresultat inte kommer att skilja sig väsentligt från den finansiella målsättningen.

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 9 oktober 2018 kl. 08:30.

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

Is a combination of assays really needed for non-animal prediction of skin sensitization potential? Performance of the GARD™ (Genomic Allergen Rapid Detection) assay in comparison with OECD guideline assays alone and in combination

Regulatory Toxicology and Pharmacology, Volume 98, October 2018, Pages 155-160, https://doi.org/10.1016/j.yrtph.2018.07.014. David W.Roberts Highlights Prediction of skin sensitization potential does not need multiple assays representing Key Events of the AOP. This has been argued on theoretical grounds and is now tested against published data. A single assay, GARD™, can outperform combinations of OECD test guideline […]

Regulatory Toxicology and Pharmacology, Volume 98, October 2018, Pages 155-160, https://doi.org/10.1016/j.yrtph.2018.07.014.

David W.Roberts

Highlights

  • Prediction of skin sensitization potential does not need multiple assays representing Key Events of the AOP.
  • This has been argued on theoretical grounds and is now tested against published data.
  • A single assay, GARD™, can outperform combinations of OECD test guideline assays.

Abstract
To meet regulatory requirements, and avoid or minimize animal testing, there is a need for non-animal methods to assess the potential of chemicals to cause skin sensitization. It is widely assumed that no one test will be sufficient and that combined data from several assays spanning key events from the adverse outcome pathway will be required. This paper challenges that assumption. The predictive performance of a single assay, the Genomic Allergen Rapid Detection (GARD™) assay, was compared with the performance, singly and in combination, of three formally validated non-animal approaches that appear as OECD test guidelines: the direct peptide reactivity assay (DPRA), the ARE-Nrf2 luciferase test method, and the human cell line activation test (h-CLAT).

It is shown here that GARD™ alone outperforms each of DPRA, ARE-Nrf2 luciferase or h-CLAT, alone or in any combination as a 2 out of 3 strategy, in terms of sensitivity, specificity and accuracy.

Based on the datasets analysed here, the sensitivity and specificity of GARD™ alone are 90–92% and 79–84% (“2 out of 3”, 86% and 76%). Thus, in any situation where the 2 out of 3 strategy is considered adequate, GARD™ alone could be used with equal or better performance.

Keywords
Skin sensitization potential, Non-animal assays, Integrated testing strategies, GARD™

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