Finland's Jurilab has developed a new microarray product designed for use in DME (drug metabolism enzyme) testing, and also signed up its first customer for the technology. Orion Pharma has become the first company in the pharmaceutical industry to license the genetic test and will use it in a forthcoming Phase I clinical trial.
Different people metabolise drugs at varying rates, due to individual differences in the levels and activities of drug metabolism enzymes. Clinical trials need to take this into account in order to minimise potential adverse drug reactions (ADRs).
Jurilab's DME microarray is used to screen candidates for clinical trials by genotyping, as well as in explaining potential deviations in response to the drug. The microarray includes naturally occurring genetic variations or single nucleotide polymorphisms (SNPs) from eight different DMEs, most of which are associated with reduced, or a complete lack of, enzyme activity.
The test also allows for detection of deletion or duplication of certain DME genes. The resultant DME genetic profile provides invaluable data to assist with interpretation of trial results, as well as potentially on the criteria for target patient groups after the drug is launched.
Marjut Ranki-Pesonen, assistant vice president, for clinical development, pharmacogenomics and new technologies at Orion, said that the content of Jurilab's microarray is broader than with other DME test options, while another advantage is that the company will not have to invest in additional equipment to use the kit. "The information received from the test will allow us to explain why some subjects have exceptionally high or low concentration of drug in their plasma. This information may be critical when deciding the optimal therapeutic dose", said Ranki-Pesonen.