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.

GARDair is the first in vitro test that can detect air-borne chemicals that cause respiratory allergies, by using a unique gene technology. This follows the international 3Rs principle, Reduce, Replace and Refine, and is the first cell-based alternative to animal testing for the respiratory tract. The grant of 2,4 million Euros means that SenzaGen can develop and refine GARDair at the same time as being able to increase the pace of commercial development and the launch of another new product line. The grant runs for 24 months.

   –  We are incredibly delighted and proud to be part of the EU's investment in the future, Horizon 2020. The fact that they choose to invest in 3Rs technologies shows how important this is. It is a confirmation of the potential of our technology platform, as well as a unique business opportunity to build on our product portfolio of commercially viable tests at a significantly faster rate, says Anki Malmborg, CEO of SenzaGen.

   –  It is important in many different industries to be able to test the capacity of chemicals to affect the respiratory system, and today there are no tests for this. There's a huge need for safety testing, and the grant from the EU gives us a unique opportunity together with partners from various different industries to develop the respiratory test of the future in accordance with OECD guidelines, says Henrik Johansson, Senior Scientist at SenzaGen.

SenzaGen's EU application has been coordinated by GAEU Consulting AB and received a exceptionally high score of 14,26 out of 15 in the EU evaluation, proving excellency both in the invention and in the application document.

Horizon 2020 in brief
Horizon 2020 is the EU's framework program for research and innovation. The program is the world's largest investment in research and innovation and has a total budget of around € 80 billion (2014-2020). The aim is to ensure the EU's global competitiveness. For more on Horizon 2020, see: https://ec.europa.eu/programmes/horizon2020/.

Bioglan is a pharmaceutical company that focuses on research, development and manufacture of medicines, especially semi-solids such as creams and ointments. Bioglan manufactures topical medicines and personal care products for customers within the pharmaceutical industry. The company works with everything from product development and clinical trials through to full-scale production. Safety testing and allergy testing are part of Bioglan's everyday routine and today human skin patch tests are the preferred method of testing end products for skin allergies. SenzaGen's GARDskin offers an alternative that may eventually replace these tests and therefore the two companies have now chosen to enter into a partnership where the use of GARDskin on complex end products will be further developed.

"With Bioglan we'll benefit from an extensive exchange of knowledge and will have the opportunity to test GARDskin on several different formulations. We will also gain a deeper understanding of the extraction process, and can thus develop our products and processes further. Our goal is that GARDskin will work even on end products, and that more companies will therefore take note of our technology and realize that there are safer and better tests than the ones which are still routinely used in many places today," says Anki Malmborg Hager, CEO of SenzaGen.

Bioglan, with its production in Malmö, seeks to depart from traditional testing methods on human skin and instead use the next generation's GARD test for safety testing of the company's products. GARDskin investigates and finds allergens in chemicals and pharmaceutical preparations through a unique genome technology that completely replaces the need for animal testing. The goal is that GARDskin should replace current tests, thus providing a better assessment of allergenicity and a more cost-effective approach.

     – Collaborating with new strong partners is an integral part of our business model. The agreement with WOOJUNG BSC means that we will be present in one of the most important Asian markets. Korea, just as India, has imposed a ban on animal testing on cosmetics. WOOJUNG BSC has a wide network of customers and partners in the life science sector, and also the company has been offering various solutions to the pharmaceutical GMP market and preclinical CRO services. This provides long-term benefits to our product portfolio and SenzaGen, says Anki Malmborg Hager, CEO of SenzaGen.

Korean company WOOJUNG BSC was established in 1989 and is one of the leading research facilities in Korea. Customers include universities, pharmaceutical companies and research institutes, to which WOOJUNG BSC provides services.

     – We offer a range of services to leading cosmetic and pharmaceutical companies and universities in Korea and with GARD we will expand and strengthen our offer. With the new legislation, we see that more and more of our customers will demand animal-free tests and with GARD, we get a safer and better test. It benefits us, our customers and all consumers, says Benjamin, ByungNyun Chun, CEO at WOOJUNG BSC. 

Since 2013, animal testing of cosmetic products is banned in the EU. Norway has decided to impose the same ban as the EU, while India, Israel, New Zealand and Turkey have introduced bans on carrying out animal testing for cosmetics in the country. In December 2015, Korea passed a similar ban which will come into effect in 2017. More bans are underway in major markets in the coming years, which provides an increasing demand for SenzaGens animal-free genomic testing.