UK contract research organization Envigo has announced it will develop and internally validate five to seven ion channel in vitro tests for measuring cardiac risk potential.  The Huntingdon-headquartered group said demand for the tests is being fuelled by changing regulations as well as technological and scientific advances that are making robust in vitro tests possible.

The Comprehensive in Vitro Proarrhythmia Assay (CiPA) recommendations are expected at the end of this year.  The CiPA initiative is a novel safety screening proposal that is intended to replace existing International Conference of Harmonization guidelines and move safety pharmacology to in vitro and in silico assessments.

From 2018 onward, Envigo expects to create between five and 10 new in vitro and in silico tests on average per year. The company said these will form an integrated suite of tests that include its existing hERG (Human Ether-a-go-go-Related Gene) assay.

Brian Burlinson, Envigo’s principal scientist and vice president of safety assessment, CRS Europe, said there has been an exponential growth in the use of non-animal technologies in pharmaceutical and chemical safety assessment, and Envigo’s goal is to be the “go to” non-clinical research organization for in vitro testing and safety development. “Longer term, we are looking to internally develop new tests or to create them in collaboration with select partners for use across a range of pharmaceutical, agrochemical and chemical products,” he said.

The company added that it is also helping to define regulations for non-animal technologies with its scientists currently participating in various OECD expert working groups.