Envigo has announced that it 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 an integrated suite of tests that include the company’s existing Human Ether-à-go-go-Related Gene (hERG) assay.
Envigo expects to create between five and 10 new in vitro and in silico tests on average per year from 2018 onwards. The demand for such tests is fuelled by changing regulatory environments as well as technological and scientific advancements that are making robust in vitro tests possible.
The range of Envigo’s current non-animal technology assays that comply with OECD regulatory guidelines span the fields of genetic toxicology, electrophysiology, metabolism, endocrine disruption, skin sensitisation, skin and eye irritation, genomics and gene expression. These tests often form an essential part of integrated approaches for testing and assessment (IATA).
Envigo is also helping to define the non-animal technologies’ regulatory environment, with its scientists currently sitting on various OECD expert working groups.
Brian Burlinson, Principal Scientist and Vice President of Safety Assessment, CRS Europe, at Envigo, said: “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.”