Almac Signs Deal to Provide Process to Extract Genetic Information from Clinical Trial Samples
News May 09, 2008
The Almac Group has announced a deal with Biogen Idec Inc to use Almac Diagnostics’ expertise in extracting genetic information from formalin fixed paraffin embedded tissue (FFPE) for SNP analysis in a Phase II trial of one of its drug candidates for the treatment of gastrointestinal stromal tumors (GIST).
Almac Diagnostics has developed capabilities to work with FFPE that allow researchers to use the samples in qPCR and microarray SNP genotyping and gene expression studies. This service is now available from Almac’s two facilities in Europe and the UK.
Most clinical material is stored as FFPE tissue blocks, which, in the past, rendered the material unsuitable for genetic analysis. Almac has developed a proprietary process that now makes it possible to unlock the genetic information stored within these samples.
Almac says that the newly validated process enables qPCR and microarray SNP genotyping from FFPE samples. This process will be used in the Biogen Idec clinical trial.
Professor Paul Harkin, President and MD, Almac Diagnostics said: “Our validated processes have led to a huge shift in conventional thinking in how we handle the genetic information trapped in the nearly 400 million FFPE samples worldwide. Our approach means that we can now access a wide range of genetic material for analysis now and in the future. Harnessing and accessing the genetic information in clinical samples will change the way pharmaceutical and biotech companies examine results from their clinical trials. These developments will enable researchers to make significant advances towards personalized medicine.”
Unlike most cells in the rest of our body, the DNA (the genome) in each of our brain cells varies from cell to cell, caused by somatic changes. But much remains unknown, including when these changes arise, their size and locations, and whether they are random or regulated. Now, researchers have developed new techniques allowing the detection of CNVs smaller than one million base pairs.