SenzaGen's Final Validation Report for the Animal-free Allergy Test GARDpotency™ has Been Submitted to the Regulatory Authorities
Published: Jul 09, 2018
LUND, Sweden, July 9, 2018 /PRNewswire/ -- SenzaGen (Nasdaq First North: SENZA) announces today that the company has submitted the official validation report for GARDpotency™ to the relevant regulatory authorities as a complement to the validation of GARDskin™. GARDpotency™ is the first animal-free allergy test on the market that can be used to evaluate chemicals according to the EU's CLP classification.
Other initiatives to measure potency today, including animal tests, only reach an accuracy of 55%-69%. Therefore, we at SenzaGen are extremely happy to be able to present the final results of the report showing that our test can classify CLP Class 1A and 1B chemical substances, quantifying the risk of causing allergies with an accuracy of 82 percent, as determined by three laboratories.
Results from the validation demonstrate that the performance of GARDskin™ together with GARDpotency™ exceeds all currently available validated methods. Worldwide approval and recommendation from ECVAM (the EU Reference Laboratory for Alternatives to Animal Testing) and OECD regarding the use of GARDskin™ and GARDpotency™ are expected in 2019.
GARDpotency™ is based on the same biological platform as GARDskin™ and both tests are expected to be approved and recommended at the same time. Together with GARDpotency™, which complements GARDskin™, SenzaGen's allergy test will be unique on the market, as it is the only test that offers animal-free tests of chemicals in line with the EU's CLP classification. The CLP classification follows the Global Harmonized System, GHS, developed by the UN to create common criteria for the classification and labelling of chemicals.
The EU Chemicals Agency ECHA, which regulates chemical use based on the REACH Regulation, requires that chemicals that may induce sensitivity (sensitization) must be potency-classified according to CLP. This has so far only been possible with a so-called LLNA (Local Lymph Node Assay) evaluation, which is an in vivo test using animals. SenzaGen's GARD™ test platform is based on human cells in vitro and genomic biomarkers, constantly delivering better accuracy than animal tests.
"Potency is extremely difficult to measure. We are therefore very happy to be able to report these results. In view of the impressive validation results for GARDpotency™, we look forward to receiving the authorities' response regarding GARDskin™ and GARDpotency™ in 2019. As a consequence of these good results, we are planning to communicate sales targets for the coming years during the second half of this year. A positive response would make our allergy test the first animal-free test that can be used for classification in accordance with CLP, the EU's standard," says Anki Malmborg Hager, CEO of Senzagen.
The results from the validation report will be presented at forthcoming scientific conferences.
For more information, please contact:
Anki Malmborg Hager
CEO, SenzaGen AB
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 over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. 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 submitted for publication, through the contact person set out above on the 6 July 2018 at 08:50
SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company's Certified Adviser. For more information, please visit www.senzagen.com.
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The following files are available for download:
http://mb.cision.com/Main/14439/2570579/875147.pdf Press release GARD potency
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