Medicyte gains significant support from BMWi - the German Federal Ministry of Economics and Technology
Compounds that damage the human genome (i.e. genotoxic) are considered to carry the risk of causing cancer. For this reason, regulatory authorities require that all chemicals exposed to the consumer, such as drugs, cosmetics and (agro)chemicals should be tested for their potential to cause genotoxicity. MediCyte has worked on developing more relevant and predictive genotoxicity assays that may ultimately replace current methods, including ethically compromised and expensive animal studies. The BMWi has granted Medicyte significant financial support to bring upcyte®-based in vitro genotoxicity tests to market maturity.
In principle, human liver cells would be ideal for genotoxicity testing, since they inherently possess the metabolic capacity to both bioactivate pro-genotoxins and detoxify genotoxic compounds. This would result in a more relevant outcome in the test and fewer false positive results (i.e. compounds that are positive in vitro but negative in vivo). However, primary liver cells have a number of disadvantages, including a limited supply of adherent cells, a limited lifespan in culture whilst maintaining the adult phenotype and, most importantly, they do not divide in culture – which is required for assays such as the micronucleus test. To overcome the lack of metabolic activation by cell lines used in current in vitro genotoxicity assays, incubations are supplemented with rodent liver extracts. However, this has been shown to lead to erroneous results, often requiring further animal testing or, even de-selection of promising compounds.
Medicyte´s upcyte® in vitro genotoxicity testing is based on the incubation of new drugs and compounds with human liver cell cultures which have both proliferating and differentiated cells. Medicyte´s upcyte® liver cells are the closest analogue to unchanged human liver cells to date. Moreover, the company can provide cells from the same human donor in virtually unlimited quantities with consistent quality. Currently, Medicyte´s upcyte® Genotoxicity Testing is the only method that meets optimal criteria: good predictivity, inherent metabolism, and sufficient availability of cells from different donors for routine testing.
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