The Sweden-based company has been developing a non-animal test for the allergenicity of proteins, and company CEO Stan Mikulowski has announced validated products should be available within 6-12 months.
At a meeting of the International Council of Chemical Association's Long-Range Research Initiative in Italy, the company presented its in-vitro assay.
Biomarker used to measure allergic response
Based on human immune competent cells the assay uses a biomarker called neopterin to measure whether or not the tested substance elicits an immune response.
The substance to be tested is incubated with the human cells for 1-2 days before being analysed for the presence of neopterin. Neopterin is used as a surrogate biomarker for the functional polarization of the cells that occurs during a type I allergic reaction, the company explained.
According to Biovator, tests on the bioassay illustrate that high-molecular weight protein allergens, low-molecular weight respiratory or contact allergens and irritants induce the release of neopterin above background levels, but non-allergenic proteins do not.
However, further work needs to be done with other proteins and known allergens to extend these results, the company said.
“We are very pleased that our development of cutting-edge technologies for In-Vitro Alternatives is moving ahead. Our commercial model is ready and our goal is to deliver validated products to key industries within 6-12 months. This will be handled via a select group of CRO [contract research organisation] industry partners, to be announced at a later date,” Mikulowsk.said.
Animal tests for allergenicity of cosmetic ingredients must be phased out by 2013 according to the European Cosmetic Directive, however as yet there are few available alternatives.