SenzaGen receives GLP approval
SenzaGen, which develops animal-free in vitro safety tests, has received the important GLP approval from Swedac for its laboratory and the use of its test platform GARD™. The internal work began in 2019 and today, May 27, the Company received the GLP approval. This is a substantial regulatory milestone since the GLP status gives SenzaGen access to customers seeking to file their products with regulators such as the Swedish Medical Products Agency or the FDA.
GLP stands for Good Laboratory Practice and is a quality system of requirements and principles to assure the quality of non-clinical safety studies. What constitutes GLP is defined by the OECD for use as a global standard requirement to ensure high-quality and reliable results for product filings and regulatory approval. Swedac, the Swedish national accreditation body, is the authority that has determined that SenzaGen’s lab meets the GLP requirements.
The approval affirms that SenzaGen’s laboratory operations have ensured that studies subject to GLP requirements can be performed with the quality specified by regulators when the study is used as documentation for regulatory purposes.
“The GLP approval is a regulatory milestone and an important part of SenzaGen’s continuing commercialization. This gives us access to a significantly broader group of customers because we can meet both the customer’s internal quality requirements and the regulatory requirements for study data used in product filings. The approval is also positive for the OECD’s ongoing approval process for GARD since Swedac’s decision shows that the method can be used in a lab subject to regulatory monitoring,” says Axel Sjöblad, CEO of SenzaGen.
For more information, please contact:
Axel Sjöblad, CEO, SenzaGen AB
Email: axel.sjoblad@senzagen.com | Mobile: +46 705 35 93 51
Tina Dackemark Lawesson, VP Marketing & Communications
Email: tina.lawesson@senzagen.com | Mobile: +46 708 20 29 44
About GARD
GARD™ consists of a group of tests for analyzing a chemical’s capacity to trigger an allergic reaction in humans. The tests target companies looking to optimize their testing strategy and increase the accuracy of their test results while avoiding animal testing. With precision and reliability, GARD improves the quality of customers’ decision-making and contributes to increased product safety while reducing the number of animal tests. SenzaGen is the only company at this time that can provide an in vitro test to determine whether a chemical causes respiratory allergies. The Company’s product portfolio consists of tests for skin and respiratory allergies: GARD™skin, GARD™air, GARD™potency and GARD™skin Medical Device.
About SenzaGen AB (publ)
SenzaGen’s technology enables the replacement of animal testing with genetic testing in test tubes to determine the allergenicity of the chemicals we come in contact with in our everyday lives, such as those 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. SenzaGen sells its tests directly in Sweden and the US as well as via partners in several other countries. In the coming years, the Company will expand geographically, partner up with more distributors and launch new, unique tests. SenzaGen has its headquarters in Lund, Sweden and a subsidiary in the US. For more information, please visit: www.senzagen.com.
SenzaGen is listed on Nasdaq Stockholm First North (ticker: SENZA), and FNCA Sweden AB, +46(0)8-528 00 399, is the company’s Certified Adviser.
