- CEO
- Peter Nählstedt
- Full Time Employees
- 36
- Sector
- Health technology
- Industry
- Biotechnology
- Address
- Building 401 Lund SN Sweden 223 81
- IPO Date
- Sep 21, 2017
- Business
- SenzaGen AB (SENZA.ST) develops and provides non-animal testing methods and advisory services for assessing the toxicological safety and efficacy of chemicals, focusing on skin sensitization, respiratory sensitization, irritation, corrosion, and related endpoints to replace traditional animal testing with human-relevant in vitro alternatives. The company's core GARD platform, powered by genomics and machine learning, includes GARDskin OECD 442E for hazard assessment with binary prediction; GARDskin Dose-Response for potency assessment; GARDskin Medical Device per ISO 10993-10 for evaluating medical devices and solid materials; and GARDair for respiratory sensitization assessment; complemented by regulatory toxicity tests such as skin corrosion (OECD 431), skin irritation (OECD 439), skin sensitization (OECD 442C/D/E), skin absorption (OECD 428), eye irritation, phototoxicity, genotoxicity, and the recently added EpiSensA method; as well as biological evaluation, biocompatibility testing, cytotoxicity, irritation services for substance-based medical devices, and specialized advisory services for pharmaceuticals, medical devices, cosmetics, and chemicals. Through subsidiaries VitroScreen s.r.l. (Italy) offering the proprietary VitroScreen ORA organoid platform for customized efficacy testing including cartilage models, and ToxHub s.r.l. (Italy) providing toxicological risk assessment and regulatory consulting, SenzaGen serves multinational customers in cosmetics, chemicals, medical devices, pharmaceuticals, and nutrition/food additives segments via direct sales and a global network of licensed contract research organizations primarily in Europe and North America.
Founded in 2010 and headquartered in Lund, Sweden, at Medicon Village, the company operates testing laboratories in Sweden and Italy, with a North American subsidiary, and employs approximately 37 staff.
Recent developments include the expanded OECD approval of GARDskin in Test Guideline No. 497 in Q2 2025, enabling testing of difficult substances like natural extracts and complex mixtures to drive demand in chemicals and cosmetics; first commercial orders for the new OECD-approved EpiSensA skin allergy test, including from the Research Institute for Fragrance Materials (RIFM); an extension of collaboration with RIFM securing a SEK 1.5 million photosensitization testing order and grant; submission of GARDskin Dose-Response for OECD approval via ECVAM; progress toward GARD inclusion in ISO 10993-10 for medical devices with successful validation study presentation and planned ring trial; initial customer order for VitroScreen ORA cartilage organoid model; and operational improvements at VitroScreen following 2024 management changes, alongside strong GARD order intake exceeding sales.