The Italian external quality assessment for RAS testing in colorectal carcinoma identifies methods-related inter-laboratory differences

Journal of Translational Medicine
Nicola NormannoGian Luigi Taddei

Abstract

In 2014 the European Medicines Agency included exon 2, 3 and 4 KRAS and NRAS testing for the selection of metastatic colorectal cancer (mCRC) patients eligible for the therapy with anti-EGFR monoclonal antibodies. The Italian Association of Medical Oncology (AIOM) and the Italian Society of Pathology and Cytology (SIAPEC) organized an external quality assessment (EQA) scheme for CRC to evaluate inter-laboratory consistency and to ensure standardization of the results in the transition from KRAS to all-RAS testing. Ten formalin fixed paraffin embedded specimens including KRAS/NRAS (exons 2, 3, 4) and BRAF (codon 600) mutations were validated by three referral laboratories and sent to 88 participant centers. Molecular pathology sample reports were also requested to each laboratory. A board of assessors from AIOM and SIAPEC evaluated the results according to a predefined scoring system. The scheme was composed of two rounds. In the first round 36% of the 88 participants failed, with 23 centers having at least one false positive or false negative while 9 centers did not meet the deadline. The genotyping error rate was higher when Sanger sequencing was employed for testing as compared with pyrosequencing (3 vs 1.3%; p = 0.01; Pearso...Continue Reading

References

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Citations

Nov 30, 2016·Expert Review of Molecular Diagnostics·Michelangelo FiorentinoRodolfo Montironi
Nov 16, 2016·Clinical Chemistry and Laboratory Medicine : CCLM·Guigao LinJinming Li
Jan 16, 2018·Virchows Archiv : an International Journal of Pathology·V TackE M C Dequeker
Sep 5, 2020·Cancer Cytopathology·Elena VigliarGiancarlo Troncone
Nov 24, 2020·Virchows Archiv : an International Journal of Pathology·Cleo KeppensElisabeth M C Dequeker
Jan 9, 2020·Annals of Oncology : Official Journal of the European Society for Medical Oncology·E MartinelliF Ciardiello

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Methods Mentioned

BETA
genotyping
PCR
dissections

Software Mentioned

AIOM
SIAPEC EQA
RAS
EQA
ESP RAS EQA
SIAPEC

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