GARDprotein demonstrates exceptional ability to identify allergens in foodstuff – new research results presented at scientific conference.

Lund, 10th October 2017 – SenzaGen (Nasdaq First North: SENZA) today announces positive results from an evaluation of GARDprotein, a test method which is developed to make it possible to eliminate allergenic proteins from today’s and tomorrow’s foodstuffs. GARDprotein has the potential to open up a new market for SenzaGen’s test platform. The results are being presented at the 3rd ImpARAS Conference in Helsingør, Denmark.

 

The results being reported at the conference show that GARDprotein has a unique ability to distinguish two almost identical proteins, one allergenic and the other non-allergenic. Allergy-inducing shrimp tropomyosin was correctly classified in the test as a protein allergen, while non-allergenic pork tropomyosin was correctly classified as a non-allergenic substance. A test method with this high precision and reliability can reduce the risk that foodstuffs are incorrectly categorized as allergenic or that their allergy-inducing properties are not detected in time.

This further evidence of the accuracy and reliability of a GARD test demonstrates the potential of SenzaGen’s technology platform with its associated pipeline of upcoming tests.

GARDprotein targets an important part of the market for cell-based in vitro toxicology tests, whose total size is estimated at 5.4 billion Euros in 2016.

“Many people are allergic to shrimp, while allergy to pork is extremely rare. GARDprotein is able to distinguish two almost identical proteins – the allergenic shrimp tropomyosin and the non-allergenic pork tropomyosin. This demonstrates additional test capabilities and opens a new potential market for us, as it can make our test a valuable future tool in the assessment of foodstuff’s allergy-inducing properties,” says SenzaGen CEO Anki Malmborg Hager.

The development of GARDprotein is supported by several industry partners and research institutes, including HESI PATC (the Health and Environmental Sciences Institute, Protein Allergenicity Technical Committee) consisting of Dupont, Syngenta and others. SenzaGen expects to launch the test in 2021, provided validation is successful.

ImpARAS (Improving Allergy Risk Assessment Strategy for New Food Proteins) is an interdisciplinary European scientific network dedicated to the development of more predictive methods for assessing proteins’ allergenic properties. Robin Gradin, industrial doctoral student at SenzaGen, will present the results of the GARDprotein evaluation today on 10th October 2017.

 

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 in 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 10 at 11:00.

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 to present at EUROTOX Congress in Slovakia

SenzaGen announces today that the company will be presenting two scientific abstracts and hold a presentation titled “21st century testing: Can one test be stand alone?” at the upcoming EUROTOX Congress in Bratislava, Slovakia.

The 53rd European Congress of the European Societies of Toxicology, EUROTOX, is to be held in Bratislava, Slovakia on September 10-13, 2017. The congress will include a multitude of symposia and workshops as well as a large exhibition area and is an important meeting point for research community and industry.

On 12 September, SenzaGen’s new Chief Scientific Officer Henrik Appelgren will give an Exhibitor Hosted presentation at the congress with the full title “21st century testing for skin sensitisation: Can one test be stand alone? Regulatory challenges and GARD applications update” Furthermore, SenzaGen is also exhibiting at the congress (Booth 25) and is presenting two scientific posters on the transferability of the GARDskin assay to two independent laboratories and the GARD platform for potency assessment of skin sensitizing chemicals.

For additional information regarding Henrik Appelgren’s presentation, visit:
www.eurotox2017.com/programme/exhibitors-meetings/senzagen/
or SenzaGen web site www.senzagen.com/event-calendar/
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 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

SenzaGen’s chairman Carl Borrebaeck has received the Biotech Builders Award 2017

SenzaGen’s chairman, Professor Carl Borrebaeck, has received the prestigious BiotechBuilders Award for his ground-breaking medical research and prominent role as entrepreneur in Life Science, including being the co-founder of SenzaGen, Immunovia, Alligator Bioscience and BioInvent. The award was announced at the annual BiotechBuilder’s meeting in Stockholm on 28 August. Through his involvement in SenzaGen, Carl Borrebaeck has contributed to the development of GARD™ – a gene-based test that evaluates the allergenic properties of chemical substances, thus eliminating the need for animal testing.

Carl Borrebaeck was given the award on the grounds of being a successful entrepreneur who contributed to the start of several new life science companies, including, Alligator Bioscience, Immunovia, BioInvent and SenzaGen, of which the first three have been introduced on the Swedish stock market. His efforts to build scientific networks, including Medicon Village, NOME (Nordic Mentor Network for Entrepreneurship) and Cancer Crosslink Conference, also contribute to his election as an outstanding “biotech builder” and good representative of Swedish life science industry.

Carl Borrebaeck’s latest start-up company SenzaGen, has its base at Medicon Village in Lund. The company develops and sells allergy tests, mainly to the cosmetics and chemical industry. SenzaGen’s test, the GARD™ (Genomic Allergen Rapid Detection) is an alternative method for allergy testing that eliminates the need for animal testing. The method has been developed for over 10 years by a research group at Lund University, led by Carl Borrebaeck, Professor and at the time Head of Institution, and Malin Lindstedt, Professor and Senior Lecturer, both at the Institution of Immunotechnology. GARD utilizes the human genome to classify chemicals, and evaluate their ability to induce allergic reactions in human cells. Today, SenzaGen owns the patents and drives the development as well as the global marketing and sales of GARD. SenzaGen is planning a listing on Nasdaq First North in September 2017.

For more information:
Anki Malmborg Hager,
CEO, SenzaGen AB
Email:  anki.malmborg.hager@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

About Biotech Builders
BiotechBuilders was first initiated in Denmark, 2002, by Dr Jørgen Thorball an early morning at Copenhagen Airport.  The news about the dying Biotech industry called for action to energize the entrepreneurs and bring new life to the industry. Dr Torberg invited the leading life science companies to initiate the first BiotechBuilders event. In this playful and inspiring environment, company founders, visionaries, venture capitalist and CEOs had the opportunity to network and exchange ideas. In 2009 the event was brought to Sweden and have since been held annually in Stockholm, and it has been a great success and much appreciated among the participating people.

SenzaGen secures patent protection for its GARDskin™ test in Europe

SenzaGen announces today that the European Patent Office (EPO) has granted a patent for GARDskin, the company’s recently launched test that determines whether chemical substances may induce skin allergies. GARD™ tests are significantly more reliable than traditional evaluation methods, and provide more comprehensive information on the allergy-inducing properties of the chemicals studied. Hence, GARDconfers increased protection level for humans. The test is carried out in vitro, thus eliminating the need for animal testing.

The recently granted European patent covers the analytical methods and genetic signatures that form the foundation of SenzaGen´s proprietary GARDskin™ technology. The patent is valid until October 2031.

“This affirmation from the European Patent Office of the merits of our technology is an important milestone in SenzaGen’s strategic plan to establish our unique GARDskin™ test as a new global standard for the industry. Robust patent protection in Europe for GARDskin™ further strengthens our company’s commercial potential and makes us even more attractive to international distribution partners,” says SenzaGen’s CEO, Anki Malmborg Hager.

The announcement from the European Patent Office relates to European Patent No. 2,633077 B, entitled: “Analytical methods and arrays for use in the identification of agents inducing sensitization in human skin”. Corresponding patent applications are currently being processed by the patent authorities in Brazil, Canada, China, Hong Kong, India, South Korea and the United States.

 

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 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

SenzaGen recruits Chief Commercial Officer and Chief Scientific Officer

SenzaGen announces today that the company has recruited Anna Chérouvrier Hansson as Chief Commercial Officer and Dr. Henrik Appelgren as Chief Scientific Officer. The company’s management is thus strengthened in the run-up to the commercialization of the company’s GARD tests, which are used to assess the allergenic properties of chemical substances.

Anna Chérouvrier Hansson – CCO, Henrik Appelgren – CSO, Marianne Olsson – CFO, Steve Smith – IP

 

The appointments announced today are the final stage in the work to strengthen SenzaGen’s management for the commercialization of the GARD tests and the company’s planned listing on Nasdaq First North. The management team has been built up gradually over the past year – at the end of 2016 Marianne Olsson started work as Chief Financial Officer, and in early 2017 Dr Steve Smith was recruited to the post of Intellectual Property Counsel.

“We are delighted to have attracted such well-qualified and industrially experienced people to SenzaGen. The company’s management now has an optimal composition for our work to establish GARD tests as the new global standard for evaluating the allergy-inducing properties of chemical substances,” says SenzaGen CEO Anki Malmborg Hager.

Anna Chérouvrier Hansson, Bachelor of Business Administration, and Master of European Business Administration and Business Law, comes most recently from a position as Director of Marketing at the listed drug company Camurus. There she was responsible for the company’s marketing department, the development and management of the medical device marketing and sales organisation and for the establishment of distribution partnerships in Asia, the USA and France. She has previously worked as Head of Business Development Life Science at Invest in Skåne, Partner at Zitha Consulting and in a number of senior positions in European pharmaceutical and chemical companies.

Henrik Appelgren is a biologist with a PhD in genetic toxicology. He has been working at the Swedish Chemicals Agency for 15 years, where he worked as Sweden’s national coordinator in the OECD Test Guideline Programme. Henrik has a deep knowledge in alternative test methods and of regulatory work in the chemical industry – both nationally and internationally. He also has long experience of health risk assessments of chemicals in all European legislation. He is, or has been, a member of several scientific expert councils including FORMAS, the Swedish Research Council, the Swedish Fund for Research Without Animal Experiments, the Scandinavian Society for Cell Toxicology and EUToxRisk.

Anna Chérouvrier Hansson takes up her position on 15th August and Henrik Appelgren on 4th September 2017.

A complete presentation of SenzaGen’s management team will be available on the company’s website when the positions are started, www.senzagen.com.

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

SenzaGen signs global distribution agreement with Charles River Laboratories

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

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

SenzaGen and AstraZeneca initiate technology development collaboration

SenzaGen has signed a collaboration agreement with the global biopharmaceutical  company AstraZeneca. The collaboration focuses on  testing and development of SenzaGen’s sensitization test GARDair, in order to distinguish between allergens and irritants in the respiratory tract. The goal is the validation of in vitro toxicological tests that could be applied to the discovery of new treatments for respiratory diseases without respiratory tract irritancy as a side effect.

The collaboration means that SenzaGen will use its leading technology platform GARD, with the help of AstraZeneca’s well-documented substance libraries, to develop a new genomic signature to distinguish allergens from irritants in the respiratory tract, something which is not possible today with in vitro methods. GARD examines and finds allergens in chemicals and medicines through a unique technology in accordance with the international 3Rs principle, Reduce, Replace and Refine, as an alternative to animal testing.

“During our research and drug discovery activities, it is important to be able to identify and mitigate potential toxicological issues as early as possible, to ensure our novel candidate drugs have the right safety profile for patients. This requires in vitro toxicological methods that are properly validated for their predictivity of clinical toxicity and that are compatible with integration into the drug discovery process. By combining SenzaGen’s technological expertise and our experience with inhaled compounds, we aim to develop a novel method to investigate whether novel drug-like molecules induce similar genomic signatures as known respiratory irritants. That could ultimately be applied to steer away from a potential irritancy hazard and enable the discovery of safer drugs for patients’” says Jorrit Hornberg, Director of Discovery Safety at AstraZeneca Gothenburg.

With this new agreement SenzaGen is initiating yet another important development collaboration with the pharmaceutical industry. SenzaGen’s focus is on introducing its tests into the pharmaceutical industry and on striving to demonstrate that there are safer and more accurate tests than those that use animals.

“This collaboration with AstraZeneca is a milestone for SenzaGen. It shows that leading pharmaceutical companies see the potential of next-generation testing and that this testing has considerable industrial value. Furthermore, the collaboration will provide SenzaGen with valuable knowledge and will help to refine and develop our GARD test for further commercial opportunities,”says
Anki Malmborg Hager, CEO of SenzaGen.

The research project will run for 12 to 18 months and is in collaboration with AstraZeneca Gothenburg, contributing to the EU Horizon 2020 project granted to SenzaGen for the development of in vitro respiratory sensitization test.

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.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Press release in pdf

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