UK’s NICE Gives Green Light to IVDs for Colorectal Cancer Treatment

Posted 04 October 2013 | By Louise Zornoza 

The UK's cost containment agency, the National Institute for Health and Care Excellence (NICE), issued draft guidance on 3 October 2013 recommending reimbursement for four in vitro diagnostic tests (IVDs) used for determining the KRAS mutation status in adults with metastatic colorectal cancer.

The tests are used by doctors to help them target more effective treatments for those patients with metastatic colorectal cancer.

The four recommended tests are:

  • Therascreen KRAS RGQ PCR Kit (Qiagen)
  • KRAS LightMix Kit (TIBMolBiol)
  • Pyrosequencing of codons 12, 13 and 61
  • MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometry of codons 12, 13 and 61

Between 35% and 40% of advanced colorectal cancers harbor a mutation in the KRAS oncogene-a gene which can cause cancer. This mutation is known to make the cancer more aggressive, leading to poorer survival compared to people whose cancer does not have the mutation. In addition, tumors with this mutation do not respond to treatment with the chemotherapy drug cetuximab, so these patients would experience the toxic side effects of the drug unnecessarily and would gain most benefit from being treated with standard chemotherapy alone.

NICE Guidance on KRAS Mutation Status IVDs

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