Envigo will develop and internally validate five to seven ion channel In vitro tests for measuring cardiac risk potential – ahead of the Comprehensive In Vitro Proarrhythmia Assay (CiPA) recommendations expected at the end of this year. These assays will form a suite of tests that include the company’s existing hERG (Human Ether-à-go-go-Related Gene) assay.
From 2018 onwards, Envigo expects to create between five to ten new in vitro and in silico tests on average per year. Demand for these tests is driven by changing regulatory environments as well as scientific advancements that are making robust in vitro tests possible. Envigo’s current non-animal technology assays that comply with OECD regulatory guidelines span the fields of genetic toxicology, electrophysiology, metabolism, endocrine disruption, skin sensitization, skin and eye irritation, genomics and gene expression. These tests often form an essential part of integrated approaches for testing and assessment (IATA).
Brian Burlinson, Principal Scientist and Vice President of Safety Assessment, CRS Europe, at Envigo remarked: "There has been an exponential growth in the use of non-animal technologies in pharmaceutical and chemical safety assessment. Envigo’s goal is to be the go to non-clinical research organisation for in vitro testing and safety development. Longer term, we are looking to internally develop new tests and or to create them in collaboration with select partners for use across a range of pharmaceutical, agro-chemical and chemical products."