Source BioScience collaborates with NIBSC on new WHO panel
Source BioScience has collaborated with NIBSC (The National Institute for Biological Standards and Control) to produce the first international genomic reference panel for KRAS codons 12 and 13 cancer mutations.
The reference panel is intended to develop controls for standardisation and quality assurance of KRAS testing. The first of its kind, it is the result of a collaborative study involving 56 laboratories from 34 countries.
Source BioScience was just one of four labs chosen from the UK. As a leading reference lab for KRAS mutation analysis, plus a leading referral centre for molecular pathology testing in the UK, Source BioScience was well placed to participate.
Details of the study
The participating laboratories were issued a batch of freeze-dried human genomic DNA material. This was to be processed to a pre-determined testing schedule where mutant-type DNA is diluted using wild-type DNA.
Each laboratory used their own routine method of KRAS mutation analysis for the studies. Source BioScience primarily uses pyrosequencing technology for all routine clinical mutation analysis – a highly considered technique that in this instance allowed SBS to contribute a set of qualitative data.
Source BioScience was also able to provide quantitative data from the testing, which helped with assigning a consensus value for the level of mutation in each standard.
Why standardisation is important
Controlled reference panels play an essential role in monitoring and maintaining quality within a laboratory. This is particularly relevant for the rapidly-changing world of clinical genetics, where frequent new and exciting technological advances need to be controlled in order to prevent a negative impact on quality.
The need for compliance also places emphasis on quality control. It’s thought the panel will help in meeting ISO15189:2012 standards, through aiding the likes of equipment acceptance testing, performance monitoring, training and more.
The future of cancer genomic diagnostics
The standardisation of KRAS testing can have a crucial impact on cancer diagnostics and therapy. Found in a wide range of cancers, KRAS mutations are primarily associated with metastatic colorectal cancer (mCRC), where they’re used as a marker for response to anti-EGFR antibody therapies. As some cancer patients with KRAS mutations can fail to respond to these therapies, accurate diagnosis of them means patients can be provided with the most effective type of treatment.
What’s more, drug licencing for such therapies requires genetic testing to be performed before a clinical decision can be made on cancer treatment, so it’s more crucial than ever that quality is standardised – an goal that this new panel will hopefully work to achieve.
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