At least five further tests to be introduced ahead of CiPA recommendations
Princeton, NJ, USA — Envigo announces 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 hERG (Human Ether-à-go-go-Related Gene) assay.
From 2018 onwards, Envigo expects to create between five to ten new in vitro tests on average per year for use in combination with in silico techniques across its contract research business. This 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 sensitization, 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. For example, Envigo is represented on OECD local tolerance groups focused on skin and eye irritation tests, technical groups that advise on the development and revision of in vitro test guidelines and guidance documents, as well as the International Council on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) group. Moreover, the company has by invitation submitted published validation data directly to the OECD and to the European Centre for the Validation of Alternative Methods (ECVAM).
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.”