SenzaGen AB received positive ESAC opinion for GARD®skin as the first genomic test for identifying skin sensitizers. EURL ECVAM, the EU Reference Laboratory for alternatives to animal testing, has announced that ESAC, their scientific advisory committee, has issued a positive opinion on the GARD®skin test method. Depending on the regulatory context, positive results obtained with GARD®skin can be used stand-alone to identify skin sensitizers and the method is recommended to be adopted as an OECD Test Guideline for skin sensitization. The announcement marks a major milestone in the regulatory approval process for GARD®, opening up new commercial opportunities for the company. ESAC has now completed its scientific evaluation, which shows that the GARD®skin assay meets the EURL ECVAM requirements for reliability in testing in preparation for regulatory filing. This means that the test is science- and evidence-based, can be transferred to other laboratories, and delivers the same performance regardless of who conducts the test. In their report, ESAC states that GARD®skin can, depending on the regulatory context, be used as stand-alone for positive results when identifying skin sensitizers, which means that no additional testing is needed. A negative result must be considered together with additional evidence. According to the positive opinion, ESAC recommends that OECD include GARD®skin on their list of internationally agreed test methods. Furthermore, it means that company’s GARD®-technology, which is based on both genomics and machine learning, has now been validated by an objective group of international experts. With the final OECD approval in place, the company will be able to offer the GARD®-tests to a significantly broader customer base in various industries, such as cosmetics and chemicals in the EU, the US and Asia.