Pharma Services Portfolio: Assay Development and Validation

According to customer's needs and based on sophisticated techniques such as mass spectrometry, sequencing and Real Time PCR we develop specific assays, like genotyping assays as well as gene expression assays. Upon development the respective assay will be formally validated. After successful completion the entire process (development and validation) is documented for the customer in a report. The newly developed assay can then be used either at Eurofins Medigenomix for the analysis of customer-specific sample groups or can be transferred on customer's request in his laboratory for his own analysis.

The customer can select specific candidate genes, containing for example certain single nucleotide polymorphisms (SNPs) and/or defined alleles, for which new genotyping assays shall be developed.

The defined genetic variants and/or alleles may either be known already (from literature or from databases) or may be the result of candidate gene analyses performed by Eurofins Medigenomix previously for the customer. As an example, this may concern genetic variants, for which a causal link to a certain drug effect could be shown.

For example the customer can define certain target genes or target gene groups to be analysed quantitatively within the scope of the pre-clinical phase of drug development. For this purpose at Eurofins Medigenomix gene-specific primer-probe combinations are developed and validated. Alternatively, already developed commercial real-time PCR assays can be used, which are then validated at Eurofins Medigenomix. These assays allow quantitative gene expression analyses by real time PCR for the respective gene in sample groups provided by the customer, for example prior to and after administration of agent candidates.