Transgenomic has completed the requirements for CE IVD labelling and has expanded distribution of its Surveyor Scan K-RAS mutation detection kit throughout most of the European Union.
The Surveyor Scan K-RAS CE IVD mutation detection kit utilises Surveyor endonuclease technology.
'Surveyor Scan is able to detect all mutations present in the entire amplified gene fragment versus looking only at a subset of the most common mutations,' said Dr Katherine Richardson, Transgenomic's technical director.
'Being able to identify all mutations, including point mutations, insertions and deletions, in the amplified region increases the clinical sensitivity of the kit, as it will find genetic changes other kits will miss.
'In addition, the detection of all mutations will result in a mutation "signature" for the amplified gene region.
'Compiling these mutation signatures may become necessary when using drug cocktails for individualised therapy, since the complete knowledge of the mutation profile for specific tumours and/or genes may be necessary to determine the specific make-up of the drug cocktail,' she added.
'The combination of Surveyor with the Wave HS platform delivers a highly sensitive way to measure somatic mutations not only in K-RAS genes, but to soon include BRAF, PIK3CA, EGFR, p53 and a host of other genes involved in cancer,' said Craig Tuttle, Transgenomic's chief executive.
'We have also designed a K-RAS kit in combination with our Cold-PCR technology, which will permit the detection of mutations in circulating blood with as much as 100 times the sensitivity of currently available tests, which will be run with Surveyor not only on our Wave, but also with other systems,' he added.
The CE IVD labelled kit will be available in the UK, Ireland, Austria, Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Slovakia, Slovenia, Spain, Sweden and Switzerland.
The company will also continue to offer a research-use-only version of the kit worldwide.
