Lund, 14th December 2017 – SenzaGen (Nasdaq First North: SENZA) today reports highly positive results from the final laboratory stage in the validation of GARDskin™. The results form an important part of the evidence in the approval process for the validation by ECVAM and OECD International Regulatory Authorities. In the recently completed evaluation, GARDskin continues to exhibit high accuracy and excellent reproducibility of test results, both within laboratories and between different laboratories. These data suggest that GARDskin outperforms all currently available validated methods.
The comprehensive laboratory evaluation of GARDskin, which is required for final regulatory validation, has produced excellent results. Three independent laboratories (Eurofins BioPharma Product Testing in Germany, Burleson’s Research Technologies in the United States and SenzaGen’s own laboratory in Lund) have carried out blind analyses of a large number of chemicals. The process has been repeated on several different occasions, in accordance with the OECD validation process. The purpose is to validate the transferability, robustness and reproducibility of the test, in order to demonstrate that GARDskin can deliver reliable results with higher accuracy than existing tests, even when used in external laboratories.
The results will be presented in detail at SOT, the International Society of Toxicology Conference, in Texas in March, and subsequently in scientific publications.
“The validation study provides convincing evidence that GARDskin works well even when the test method is used in external laboratories. The results reinforce the scientific basis for GARDskin in the process of obtaining regulatory approval and inclusion in international test guidelines. We are delighted with the outcome which shows that GARD consistently outperforms all existing validated test methods,” says SenzaGen’s CEO, Anki Malmborg Hager.
The results from the completed validation study constitute an important part of the basis for the forthcoming evaluation of SenzaGen’s tests in the ECVAM Scientific Committee and within the OECD. Regulatory approval and recommendation on the use of GARDskin are expected from the OECD in April 2019. GARDpotency™, which is based on the same biological platform, is being validated in parallel with GARDskin, and is thus expected to be approved and recommended at the same time.
GARDskin will have significant potential to meet the increasing demand in the cosmetics, chemicals and pharmaceutical industries for reliable, animal-free testing methods to assess the allergy-inducing properties of chemical substances.
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
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 the 14 December 2017 at 08:30.
SenzaGen AB are listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit www.senzagen.com