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
Telephone: +46 768 284822
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.
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.