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We have worked with a wide variety of commercial companies developing assays for diagnostic tests and a w

Assay validation is based on established techniques such as:

Trust on our experience in assay development, including genotyping assays and gene expression assays.

After successful completion of assay development and validation it is documented in a report. The newly developed and validated assays can then be used at Eurofins Genomics for the analysis of customer-specific sample groups. Alternatively, they can be transferred to the customer or any third party for subsequent analyses. The customer can select specific candidate genes, containing, for example, certain single nucleotide polymorphisms (SNPs) and/or defined alleles as a basis for new genotyping assays to be developed.

The defined genetic variants and/or alleles may either be already known (from literature or from databases) or may be the result of previous candidate gene analyses performed by Eurofins Genomics for the customer. This may include genetic variants, for which a causal link to a certain drug effect could be shown.

The customer can define certain target genes or target gene groups to be analyzed quantitatively within the scope of the pre-clinical phase of drug development. Assay development and validation for gene-specific primer-probe combinations are performed for this purpose at Eurofins.

Alternatively, pre-developed commercially available Real-Time PCR assays can be used. They are then verified or validated at Eurofins Genomics. These assays allow quantitative gene expression analyses by Real-Time PCR for the respective gene in the provided sample groups, prior to and after administration of agent candidates.

Eurofins Genomics is certified according to cGMP, GLP, CAP, CLIA, ISO 9001, ISO 13485 and ISO 17025 and audited by pharmaceutical clients.

Learn more about developing a custom assay by visiting the Molecular Diagnostics webpage or contacting us.