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Purpose  Rapid advances in the understanding of cancer biology have transformed drug development thus leading to the approval of targeted therapies and to the development of molecular tests to select patients that will respond to treatments.  KRAS  status has emerged as a negative predictor of clinical benefit from anti-EGFR antibodies in colorectal cancer, and anti-EGFR antibodies use was limited to  KRAS  wild type tumors. In order to ensure wide access to tumor molecular profiling, the French  N ational  Ca ncer  I nstitute (INCa) has set up a national network of 28 regional molecular genetics centers. Concurrently, a nationwide external quality assessment for  KRAS  testing (MOKAECM) was granted to analyze reproducibility and costs.    Methods  96 cell-line DNAs and 24 DNA samples from paraffin embedded tumor tissues were sent to 40 French laboratories. A total of 5448  KRAS  results were collected and analyzed and a micro-costing study was performed on sites for 5 common methods by an independent team of health economists.    Results  This work provided a baseline picture of the accuracy and reliability of  KRAS  analysis in routine testing conditions at a nationwide level. Inter-laboratory Kappa values were >0.8 for  KRAS  results despite differences detection methods and the use of in-house technologies. Specificity was excellent with only one false positive in 1128 FFPE data, and sensitivity was higher for targeted techniques as compared to Sanger sequencing based methods that were dependent upon local expertise. Estimated reagent costs per patient ranged from €5.5 to €19.0.    Conclusion  The INCa has set-up a network of public laboratories dedicated to molecular oncology tests. Our results showed almost perfect agreements in  KRAS  testing at a nationwide level despite different testing methods ensuring a cost-effective equal access to personalized colorectal cancer treatment.

plos one

Performance and Cost Efficiency of KRAS Mutation Testing for Metastatic Colorectal Cancer in Routine Diagnosis: The MOKAECM Study, a Nationwide Experience