A global medical device company has decided to continue using SenzaGen’s most recently launched test, GARD®skin Medical Device, for risk assessment of their materials to prevent skin allergies. The order is valued at approximately SEK 0.6 million, and the tests will be performed in accordance with the OECD Principles of Good Laboratory Practice (GLP) at SenzaGen’s laboratory in Lund.
The medical device company placed the order after evaluating the GARD test method on a small scale earlier this year. The company operates globally based out of Europe and engages in innovative product development in-house with an aim to replace animal testing with alternative methods in the material risk assessment process to the greatest degree possible.
“We are very pleased with this key customer’s continued trust in both SenzaGen and our tests. Our test method gives the customer rapid and reliable answers to whether substances in their products can cause allergies, even for substances that are traditionally more difficult to test. The order shows that we meet the needs of the medical device industry, one of the industries we prioritize in our marketing and sales activities," says SenzaGen CEO Axel Sjöblad.
Launched in fall 2019, the GARD®skin Medical Device test provides a highly accurate and ethical alternative to skin sensitization testing of materials in medical devices. An update process is currently underway for the global medical device ISO standard, which advocates the inclusion of alternative risk assessment methods to replace animal testing in biological evaluation for medical device filings. SenzaGen’s goal is for GARD®skin Medical Device to be included in the new ISO standard.