Multi-Center Evaluation of the Fully Automated PCR-Based Idylla™ KRAS Mutation Assay for Rapid KRAS Mutation Status Determination on Formalin-Fixed Paraffin-Embedded Tissue of Human Colorectal Cancer.
Since the advent of monoclonal antibodies against epidermal growth factor receptor (EGFR) in colorectal cancer therapy, the determination of RAS mutational status is needed for therapeutic decision-making. Most prevalent in colorectal cancer are KRAS exon 2 mutations (40% prevalence); lower prevalence is observed for KRAS exon 3 and 4 mutations (6%) and NRAS exon 2, 3, and 4 mutations (5%). The Idylla™ KRAS Mutation Test on the molecular diagnostics Idylla™ platform is a simple (<2 minutes hands-on time), highly reliable, and rapid (approximately 2 hours turnaround time) in vitro diagnostic sample-to-result solution. This test enables qualitative detection of 21 mutations in codons 12, 13, 59, 61, 117, and 146 of the KRAS oncogene being clinically relevant according to the latest clinical guidelines. Here, the performance of the Idylla™ KRAS Mutation Assay, for Research Use Only, was assessed on archived formalin-fixed paraffin-embedded (FFPE) tissue sections by comparing its results with the results previously obtained by routine reference approaches for KRAS genotyping. In case of discordance, samples were assessed further by additional methods. Among the 374 colorectal cancer FFPE samples tested, the overall concordance between the Idylla™ KRAS Mutation Assay and the confirmed reference routine test results was found to be 98.9%. The Idylla™ KRAS Mutation Assay enabled detection of 5 additional KRAS-mutated samples not detected previously with reference methods. As conclusion the Idylla™ KRAS Mutation Test can be applied as routine tool in any clinical setting, without needing molecular infrastructure or expertise, to guide the personalized treatment of colorectal cancer patients.
Laboratory of Biopathology, Institut du Cancer de Montpellier, Montpellier, France.
Jérôme
J
Solassol
Laboratory of Biopathology, Institut du Cancer de Montpellier, Montpellier, France.
Julie
J
Vendrell
Institute of Pathology, Klinikum Augsburg, Augsburg, Germany.
Bruno
B
Märkl
Institute of Pathology, Klinikum Augsburg, Augsburg, Germany.
Christian
C
Haas
Pathology Department, Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.
Beatriz
B
Bellosillo
Oncology Department, Hospital del Mar, IMIM, Barcelona, Spain.
Clara
C
Montagut
Queen Elizabeth Hospital, Birmingham, United Kingdom.
Matthew
M
Smith
Queen Elizabeth Hospital, Birmingham, United Kingdom.
Brendan
B
O'Sullivan
Department of Pathology, Hôpital Erasme - Université Libre de Bruxelles, Brussels, Belgium.
Nicky
N
D'Haene
Department of Pathology, Hôpital Erasme - Université Libre de Bruxelles, Brussels, Belgium.
Marie
M
Le Mercier
Department of Pathology, Rigshospitalet Copenhagen, Copenhagen, Denmark.
Morten
M
Grauslund
Department of Pathology, Rigshospitalet Copenhagen, Copenhagen, Denmark.
Linea Cecilie
LC
Melchior
Royal London Hospital, London, United Kingdom.
Emma
E
Burt
Royal London Hospital, London, United Kingdom.
Finbarr
F
Cotter
Molecular Genetic Unit, Laboratoire National de Santé, Dudelange, Luxembourg.
Daniel
D
Stieber
Department of Pathology, Laboratoire National de Santé, Dudelange, Luxembourg.
Fernando de Lander
FL
Schmitt
Molecular Pathology Unit, Department of Laboratory Medicine, Niguarda Cancer Center, ASST - Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Valentina
V
Motta
Molecular Pathology Unit, Department of Laboratory Medicine, Niguarda Cancer Center, ASST - Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Calogero
C
Lauricella
Department of Cellular Pathology, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.
Richard
R
Colling
Department of Cellular Pathology, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.
Elizabeth
E
Soilleux
Department of Medicine (DIMED), Surgical Pathology Unit, University of Padua, Padua, Italy.
Matteo
M
Fassan
Department of Medicine (DIMED), Surgical Pathology Unit, University of Padua, Padua, Italy.
Claudia
C
Mescoli
Platform of Somatic Tumor Molecular Genetics, Centre Hospitalier Régional Universitaire de Tours, Tours, France.
Christine
C
Collin
Platform of Somatic Tumor Molecular Genetics, Centre Hospitalier Régional Universitaire de Tours, Tours, France.
Jean-Christophe
JC
Pagès
Biocartis, Mechelen, Belgium.
Peter
P
Sillekens
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