SenzaGen Invited to High-Tech Health Research Expo in Washington, D.C.

SenzaGen have been invited by U.S. Representative Tom Marino to present the company's technology at the High-Tech Health Research Expo in Washington, D.C., where SenzaGen will meet US congressmen and federal procurement officials interested in the use of high-tech human-focused methods to replace animal tests. The Expo takes place on September 15th, 2016.

The High-Tech Health Research Expo is organized by U.S. Representative Tom Marino who has been an outspoken leader for increased investments in this sector of the healthcare industry. The market for alternative and animal-free test methods is growing rapidly and there is a great interest for its benefits – scientifically and economically as well as from a public health perspective.

    – The provisions to reduce animal testing under the reformed Toxic Substances Control Act (TSCA) will ensure an even bigger interest in the field and SenzaGen has a natural fit in this with its test being validated for the international market by OECD says Brian Rogers, CEO of SenzaGen Inc. 

At the Expo, selected companies will have the opportunity to present their technologies to Members of congress, congressional staffers and other representatives from different government agencies. The goal of the Expo is to help advance this sector of the healthcare industry by creating an opportunity for the best and the brightest in the field to efficiently reach the largest number of decision-makers at once. 

   –  We are very proud to participate. Now, our US subsidiary will have the opportunity to reach out to some of the most influential members of Congress, who really have a say in our industry. We see it as a confirmation of our US investment and our unique test method GARD says Anki Malmborg-Hager, CEO of SenzaGen Sweden. 

High-Tech Health Care Expo takes place at the Cannon House Office Building in Washington, DC on September 15, 2016. SenzaGen will participate with their U.S: employees, and will have a stand where the company will demonstrate the latest technique to replace animal testing when performing allergy testing of chemicals and chemical ingredients.

SenzaGen initiates cooperation with partners in Europe and the US

The final and most important step in SenzaGen's formal validation process of the sensitization test GARD has now commenced through partnerships with two external laboratories, Eurofins (Germany) and Burleson (USA). These partners will now verify GARD's reliability and reproducibility, which will allow the test to be carried out by external contract laboratories.

In this Ring TrialSenzaGen's partners, Eurofins BioPharma Product Testing in Germany and Burleson Research Technologies in the US, will be provided with a number of encoded chemicals to be tested with GARD. The verification of GARD as a robust and reproducible test will open up a new market for SenzaGen, at the same time confirming GARD's unique characteristics.

"With the validation and verification of GARD as a robust test, we can now promote GARD on a broad front in our priority sectors," says Anki Malmborg Hager, CEO of SenzaGen.

GARD has previously undergone both scientific and industrial validation. The test method, which is based on an innovative genomic technology, offers an alternative to existing tests at a time when animal testing is increasingly prohibited.

"With a successful Ring Trial we and our existing customers will have further confirmation of GARD's quality and efficiency, and it will open up new opportunities for us, not least from a regulatory perspective," says Anki Malmborg Hager, CEO of SenzaGen.

The current validation by Eurofins and Burleson will run during the fall and then be reported to EURL ECVAM for review and approval. The result of the validation will provide additional and enhanced opportunities to introduce GARD at various contract laboratories, thus providing increased market penetration.

For more information:

Anki Malmborg Hager, CEO, SenzaGen AB     
E-mail: amh@senzagen.com
Phone: +46 768 284822
Brian Rogers, CEO, SenzaGen Inc
E-mail:
brian.rogers@senzagen.com
Phone: +1 530 304 7648


About GARD

By analyzing 200 and 389 markers, depending on the test, GARD generates massive amounts of data and delivers results with 90 % prediction accuracy. This can be compared to the gold standard, animal tests in mice, that provides 72 % prediction. SenzaGen’s test also has the ability to measure potency (strength) of a substance and can thus determine the degree to which a substance is an allergen.

About SenzaGen
SenzaGen provides dermal and respiratory in vitro testing for the cosmetic, chemical and pharmaceutical industries replacing the need for animal testing. The company's unique test, GARD, is based on research from the Department of Immuno Technology at Lund University. SenzaGen is based at Medicon Village in Lund, Sweden.

About Eurofins BioPharma Product Testing, Munich
Eurofins is one of the world's largest laboratory groups with over 23,000 employees in 39 countries and more than 225 laboratories worldwide. The company offers comprehensive service that include testing of drug substance, final product, intermediates, and starting materials for both small and large molecule drug products as well as chemical and microbiological analyses in agriculture, food and environment.

About Buleson Research Technologies
Burleson Research Technologies (BRT) is a Contract Research Organization (CRO) in North Carolina that provides laboratory services to clients from the biotechnology, pharmaceutical, chemical manufacturing, government, and healthcare industries with proof-of-concept, preclinical, and clinical immunotoxicology studies.

SenzaGen wins DI’s Gasellsprånget – most promising company to become Supergasell within 5 years

On May 25, SenzaGen was elected winner at the Swedish newspaper Dagens Industri’s event and competition Gasellsprånget, at the national finale in Gothenburg. After a tough round of questions and an audience poll, SenzaGen was elected winner with the greatest market potential and future outlook, leaving the competitor DigiExam a close second.

On May 25, SenzaGen was elected winner at the Swedish newspaper Dagens Industri’s event and competition Gasellsprånget, at the national finale in Gothenburg. After a tough round of questions and an audience poll, SenzaGen was elected winner with the greatest market potential and future outlook, leaving the competitor DigiExam a close second.

-SenzaGen has great future potential in a new and growing global market. We have been working very hard which makes it particularly rewarding to receive this award and the attention it creates. We are seeing an increased interest in our technology and I am confident that this award will lead to more exciting business opportunities in Europe and globally, says Anki Malmborg Hager, CEO of SenzaGen.

About Gasellsprånget

Gasellsprånget is a competition highlighting Swedish growth companies on the rise. The competition is hosted by the Swedish newspaper Dagens Industri and is split into several regional competitions, from which two contestants are chosen to participate in the national finale.

"In the selection of finalists for Gasellsprånget 2016, the jury nominated the companies that have the best opportunities to become Supergasell within a 5-year period, based on analysis and on-stage presentations by the competing companies.”

For more information:
Anki Malmborg Hager,
CEO, SenzaGen AB
E-mail: amh@senzagen.com
Phone: +46 768 284822

SenzaGen elected winner at Gasellsprånget in Malmö

After a thrilling presentation and questioning round, SenzaGen was elected the winner at the local edition of Gasellsprånget in Malmö, Sweden. SenzaGen now has the opportunity to win Gasellsprånget on a national level at the finale in Gothenburg, on May 25.

After a thrilling presentation and questioning round, SenzaGen was elected the winner at the local edition of Gasellsprånget in Malmö, Sweden. SenzaGen now has the opportunity to win Gasellsprånget on a national level at the finale in Gothenburg, on May 25.

On May 11, the Swedish newspaper Dagens Industri hosted the local edition of Gasellsprånget in Malmö, Sweden. A competition which names the fastest growing companies in Sweden. The event was hosted at Clarion Hotel & Congress Malmö Live where participants got the opportunity to listen to presentations about entrepreneurship and development in the region, as well as mingle and network. SenzaGen was one of two companies who, during the evening, had the opportunity to present their company to the audience and a panel experts. After a round of questions from the experts, the audience voted and announced SenzaGen as the winner of Gasellsprånget Malmö.

-This feels like a great win and shows that there are many who believe in us, our business model and the team that we have put together to take the company forward. This event was a very good and exciting environment to pitch in, with many interesting questions from the panel of experts. I am delighted and overwhelmed by all who voted for us, says Anki Malmborg Hager, CEO of SenzaGen.

Two finalists, selected by a jury, will now move forward and get to compete in the national finale at Gasellträffen in Gothenburg, on May 25. Based on the jury’s deliberation, analysis of the companies and an on-stage company presentation, the jury will select the finalist with the best opportunity to become a Supergasell within a 5-year-period.

For more information:
Anki Malmborg Hager,
CEO, SenzaGen AB
E-mail: amh@senzagen.com
Phone: +46 768 284822

GARD approved for validation within the OECD

GARD, Senzagen´s in vitro assay for sensitization, has been included in the OECD Test Guideline Programme (TGP) work plan with the TGP No 4.106. The decision was made at the WNT National Coordinators Test guideline programme meeting in the end of April. The validation process for GARD will now be initiated.

GARD, Senzagen´s in vitro assay for sensitization, has been included in the OECD Test Guideline Programme (TGP) work plan with the TGP No 4.106. The decision was made at the WNT National Coordinators Test guideline programme meeting in the end of April. The validation process for GARD will now be initiated.

SenzaGen’s test Genomic Allergen Rapid Detection (GARD) has been reviewed by all OECD WNT (The Working Group of the National Coordinators of the Test Guidelines Programme (WNT)) task force members and has been included in the Test Guideline Programme. This means that the process of formally validating GARD can begin. The purpose of the validation process is to show that GARD is a reproducible assay that can be use by external laboratories. The assay will be transferred externally to perform a so called “ring trial”.

 – This is a very important decision for the development of GARD as an international sensitization test and we are very confident we will have a successful ring trial. Even if our customers have been convinced by the quality of our test, it will make a big difference from a regulatory point of view when the test is validated, says Anki Malmborg Hager

The GARD test has been scientifically validated and has gone through successful in house validations prior to this with industrial partners. The test assay is based on a new innovative genomic technique which is argued to be the future of sensitization testing now that animal bans are more and more prevailing. As the chemical industry needs to find accurate and reliable tests, GARD will be an important player on the testing market once it has finalised its validation.

 – The OECD WNT representatives were very interested and positive to the GARD test and to include it in the TGP workplan. The representatives also look forward to receiving information regarding the formal validation, when these results are available. The demand is high for new alternative test methods and it has been an interesting journey as a representative for Swedish Chemicals Agency (Kemikalieinspektionen) to present GARD to OECD as it has such great potential. I am very much looking forward to follow the future for this test, says Henrik Appelgren, national coordinator at Kemikalieinspektionen.

Two external laboratories will now test GARD on several different chemicals to confirm that the test is reproducible. This process has started and final validation is expected within one year.

For more information:

Anki Malmborg Hager, CEO, SenzaGen AB
E-mail: amh@senzagen.com
Phone: +46 768 284822

SenzaGen talks about start-ups and entrepreneurship in meeting with Swedish Parliament in Stockholm – and local visit at Medicon Village

As of nine years/each year, the Swedish business organisation ALMI Skåne hosts a much appreciated and well-attended meeting between members of parliament and entrepreneurs from the start-up scene in Skåne and Blekinge. SenzaGen was one of the three attending companies, represented by the CEO Anki Malmborg Hager and one result of the meeting is a local visit by the MPs to Medicon Village in May

As of nine years/each year, the Swedish business organisation ALMI Skåne hosts a much appreciated and well-attended meeting between members of parliament and entrepreneurs from the start-up scene in Skåne and Blekinge. The ninth edition of the meeting took place on 19 of April, at the parliament in Stockholm.

The aim of the meeting is to highlight the positive diversity within the business scene in Skåne, Sweden, and to shed some light on the reality in which these companies live and breath. This year, three local companies attended the meeting where they were able to present and discuss their companies prospects’, opportunities and challenges. The personal setting of the meeting was appreciated by both MPs and entrepreneurs.

SenzaGen was one of the three attending companies, represented by the CEO Anki Malmborg Hager who took the opportunity to present SenzaGen and her experiences and thoughts about entrepreneurship. The presentation covered the journey that SenzaGen has taken since the start in 2010 as well as the situation of other companies originating from Lund University.

– I think the meeting was very fruitful. The representatives of the Committee on Industry and Trade and the Committee on Education were very familiar with and committed to the issues that are most important to us as a spin out from Lund University University. For that reason, it is especially exciting that they will visit us at Medicon Village in May, says Anki Malmborg Hager, CEO of SenzaGen AB.

The Committee on Education and the Committee on Industry and Trade will visit Medicon Village and SenzaGen at two separate occasions during May.

SenzaGen once again makes it to the 33-list

For the second year in a row, SenzaGen takes a place on the prestigious 33-list where the magazines Ny Teknik and Affärsvärlden for the ninth time appoint the hottest young technology companies in Sweden. The presentation took place at the Munich Brewery in Stockholm on April 12.

For the second year in a row, SenzaGen takes a place on the prestigious 33-list where the magazines Ny Teknik and Affärsvärlden for the ninth time appoint the hottest young technology companies in Sweden. The presentation took place at the Munich Brewery in Stockholm on April 12.

Based at Medicon Village in Lund, SenzaGen develops and implements animal-free tests on chemicals and proteins for classification of sensitizers, primarily for the cosmetics and pharmaceutical industries. SenzaGen’s test GARD (Genomic Allergen Rapid Detection) has been developed over the last 15 years ad measures significantly more parameters than existing tests on the market, as the test is based on gene analysis in human cells. This makes GARD the safest and most efficient test. GARD has mainly been used for testing in the cosmetics industry and the EU has a ban on the testing of cosmetics on animals. In the spring of 2016, GARD has also started to be used in the pharmaceutical industry for the genetic testing of potential drugs in the early phase development.

During 2015 SenzaGen completed a new share issue of M 44 SEK in order to accelerate the company's development, scale up the sales organization, finalize the ongoing validation processes and develop new tests in GARD portfolio. The company opened a subsidiary in the US early 2016 in order to increase its market penetration.

-We appreciate the attention that making it to the 33-list gives us. Being a pioneer, breaking traditional behaviors and patterns with new technology, is challenging but so far SenzaGen has been successful. We see a large interest, a growing demand and a real need for our test in a variety of industries, says Anki Malmborg Hager, CEO of SenzaGen.

About the 33-list
The 33-list is based on nominations by companies from all over Sweden and the winners are appointed jointly by the editorial staff of the NyTeknik and Affärsvärlden. The jury looks for companies with a unique product or service based around a clear innovation with great international potential – an innovation that has the potential to change the rules of the game in their industry. To make it on the list must now be based in Sweden up to 7 years old. For more information, visit http://www.33-listan.se  (In Swedish)

For more information:
Anki Malmborg Hager,
+ 46 768-284 822, amh@senzagen.com

www.senzagen.com

Potency potential of chemicals using GARD shown by independent laboratory

The platform that forms the basis for the GARD sensitization assay, has been shown to have the potential to be an accurate tool for measuring the potency of sensitizing chemicals. The study was performed by an independent research group at Department of Immunotechnology, Lund University in Sweden and presented at the Society of Toxicology 55th Annual Meeting in New Orleans, 2016.

The platform that forms the basis for the GARD sensitization assay, has been shown to have the potential to be an accurate tool for measuring the potency of sensitizing chemicals. The study was performed by an independent research group at Department of Immunotechnology, Lund University in Sweden and presented at the Society of Toxicology 55th Annual Meeting in New Orleans, 2016.

The new data were presented on Tuesday at the Society of Toxicology 55th Annual Meeting in New Orleans, poster session “Alternative Models for Ocular and Skin Toxicity”, abstract number 2205, P136.

-We have for a long time seen indications that this platform could predict potency and we are very happy to be able to present data that further points in that direction now, since it opens up completely new possibilities in skin sensitizations, says Assoc. Prof. Malin Lindstedt, heading the group at Department of Immunotechnology.

Based at Medicon Village in Lund, SenzaGen develops and implements animal-free tests on chemicals and proteins for classification of sensitizers, primarily for the cosmetics and pharmaceutical industries. SenzaGen’s test GARD (Genomic Allergen Rapid Detection) measures significantly more parameters than existing tests on the market and has previously shown to deliver the most accurate prediction for hazard classification of chemicals. Now it has also shown potential to be a key player in the important field of risk assessment of chemicals by being able to predict the potency of chemicals.

-Potency has been the long-sought for application of sensitization tests. In risk assessment it is imperative to be able to predict not only the hazard of a chemical but more importantly how strong inducer of sensitization it is, i.e. the potency of the chemical. Lund University has now in a large study shown that GARD has this ability, which makes GARD unique, and we are looking forward to take part of this and develop it further, says Anki Malmborg Hager, CEO of SenzaGen AB.

SenzaGen establishes subsidiary in the US

To quickly strengthen its commercial presence in the US market, Swedish SenzaGen AB expands globally and establishes a subsidiary in California.

SenzaGen, which develops and implements non-animal allergy tests of chemicals and proteins, for the chemical, pharmaceutical and cosmetic industries, expands its sales organization and prepares the company for an IPO in 2017. Senzagen, a Lund University Department of Immunotechnology spin-out was recently recognized as one of Sweden’s most promising young and innovative companies.

-In line with our strategy to establish a commercial presence in key markets, Senzagen has established a subsidiary in the US. The US represents the world's largest pharmaceutical and chemicals markets, and one of the largest within cosmetics. To capture market share, it is crucial that we have a local presence, says Anki Malmborg-Hager, CEO of SenzaGen AB.

Responsible for Senzagen’s US operations will be toxicologist Dr. Brian Rogers as US CEO, and Head of business development will be immunologist Dr. Sandra Reynoso.

-Nearly 50% of all animal research experiments today are performed in the US, and we want to be there to help replace these tests and offer the market a better and much safer test with our GARD. Together with our local team and their strong network, I look forward to building SenzaGen’s brand as the market leader in allergy testing in the US, says Anki Malmborg-Hager.

For more information, please contact:
Anki Malmborg Hager, Ph D, CEO,
E-mail: amh@senzagen.com
SE: +46 768 284822

Brian Rogers, Ph D, CEO US
brian.rogers@senzagen.com
US: +1 530 304 7648

About SenzaGen

SenzaGen provides in vitro dermal and respiratory testing for the cosmetic, chemical and pharmaceutical industries replacing the need for animal testing. The company's unique test GARD is based on research from the Department of Immunotechnology at Lund University. SenzaGen is based at Medicon Village in Lund, Sweden.

About GARD
By analyzing 200 and 389 genomic markers, depending on the test, instead of 1-2 markers as competing methods, GARD delivers results with 90 % accuracy. This can be compared to the golden standard, animal tests on mice, that provide 72 % accuracy. SenzaGen’s test also has the ability to measure potency (strength) of a substance and can thus determine the degree to which a substance cause allergy.

SenzaGen establishes subsidiary in the US

To quickly strengthen its commercial presence in the US market, Swedish SenzaGen AB expands globally and establishes a subsidiary in California.

To quickly strengthen its commercial presence in the US market, Swedish SenzaGen AB expands globally and establishes a subsidiary in California.

SenzaGen, which develops and implements non-animal allergy tests of chemicals and proteins, for the chemical, pharmaceutical and cosmetic industries, expands its sales organization and prepares the company for an IPO in 2017. Senzagen, a Lund University Department of Immunotechnology spin-out was recently recognized as one of Sweden’s most promising young and innovative companies.

– In line with our strategy to establish a commercial presence in key markets, Senzagen has established a subsidiary in the US. The US represents the world's largest pharmaceutical and chemicals markets, and one of the largest within cosmetics. To capture market share, it is crucial that we have a local presence, says Anki Malmborg-Hager, CEO of SenzaGen AB.

Responsible for Senzagen’s US operations will be toxicologist Dr. Brian Rogers as US CEO, and Head of business development will be immunologist Dr. Sandra Reynoso.

-Nearly 50% of all animal research experiments today are performed in the US, and we want to be there to help replace these tests and offer the market a better and much safer test with our GARD. Together with our local team and their strong network, I look forward to building SenzaGen’s brand as the market leader in allergy testing in the US, says Anki Malmborg-Hager.

For more information, please contact:
Anki Malmborg Hager, Ph D, CEO,
E-mail: amh@senzagen.com
SE: +46 768 284822
US: +1 530 867 5600