scholarly journals 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

PLoS ONE ◽  
2016 ◽  
Vol 11 (9) ◽  
pp. e0163444 ◽  
Author(s):  
Jérôme Solassol ◽  
Julie Vendrell ◽  
Bruno Märkl ◽  
Christian Haas ◽  
Beatriz Bellosillo ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Kras Mutation ◽  
Human Colorectal Cancer ◽  
Mutation Status ◽  
Formalin Fixed Paraffin ◽  
Formalin Fixed Paraffin Embedded ◽  
Mutation Assay ◽  
Formalin Fixed ◽  
Kras Mutation Status

scholarly journals Performance of a novel KRAS mutation assay for formalin-fixed paraffin embedded tissues of colorectal cancer

SpringerPlus ◽  
2015 ◽  
Vol 4 (1) ◽  
Author(s):  
Kazuko Sakai ◽  
Azusa Yoneshige ◽  
Akihiko Ito ◽  
Yoji Ueda ◽  
Satoshi Kondo ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Kras Mutation ◽  
Formalin Fixed Paraffin ◽  
Formalin Fixed Paraffin Embedded ◽  
Mutation Assay ◽  
Formalin Fixed

scholarly journals KRAS Mutation Detection in Paired Frozen and Formalin-Fixed Paraffin-Embedded (FFPE) Colorectal Cancer Tissues

2011 ◽  
Vol 12 (5) ◽  
pp. 3191-3204 ◽  
Author(s):  
Jérome Solassol ◽  
Jeanne Ramos ◽  
Evelyne Crapez ◽  
Majda Saifi ◽  
Alain Mangé ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Kras Mutation ◽  
Mutation Detection ◽  
Formalin Fixed Paraffin ◽  
Formalin Fixed Paraffin Embedded ◽  
Cancer Tissues ◽  
Formalin Fixed

scholarly journals Discordance of KRAS Mutational Status between Primary Tumors and Liver Metastases in Colorectal Cancer: Impact on Long-Term Survival Following Radical Resection

Cancers ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 2148
Author(s):  
Francesco Ardito ◽  
Francesco Razionale ◽  
Lisa Salvatore ◽  
Tonia Cenci ◽  
Maria Vellone ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Primary Tumor ◽  
Kras Mutation ◽  
Colorectal Tumor ◽  
Term Survival ◽  
Primary Tumors ◽  
Mutation Status ◽  
Primary Colorectal Tumor ◽  
Kras Mutation Status

If KRAS mutation status of primary colorectal tumor is representative of corresponding colorectal liver metastases (CRLM) mutational pattern, is controversial. Several studies have reported different rates of KRAS discordance, ranging from 4 to 32%. Aim of this study is to assess the incidence of discordance and its impact on overall survival (OS) in a homogenous group of patients. KRAS mutation status was evaluated in 107 patients resected for both primary colorectal tumor and corresponding CRLM at the same institution, between 2007 and 2018. Discordance rate was 15.9%. Its incidence varied according to the time interval between the two mutation analyses (p = 0.025; Pearson correlation = 0.2) and it was significantly higher during the first 6 months from the time of primary tumor evaluation. On multivariable analysis, type of discordance (wild-type in primary tumor, mutation in CRLM) was the strongest predictor of poor OS (p < 0.001). At multivariable logistic regression analysis, the number of CRLM >3 was an independent risk factor for the risk of KRAS discordance associated with the worst prognosis (OR = 4.600; p = 0.047). Results of our study suggested that, in the era of precision medicine, possibility of KRAS discordance should be taken into account within multidisciplinary management of patients with metastatic colorectal cancer.

scholarly journals Multi-center real-world comparison of the fully automated Idylla™ microsatellite instability assay with routine molecular methods and immunohistochemistry on formalin-fixed paraffin-embedded tissue of colorectal cancer

2020 ◽  
Author(s):  
Ana Velasco ◽  
Fatma Tokat ◽  
Jesper Bonde ◽  
Nicola Trim ◽  
Elisabeth Bauer ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Microsatellite Instability ◽  
Real World ◽  
Diagnostic Testing ◽  
Molecular Methods ◽  
Tissue Sections ◽  
Formalin Fixed Paraffin ◽  
Formalin Fixed Paraffin Embedded ◽  
High Concordance ◽  
Formalin Fixed

Abstract Microsatellite instability (MSI) is present in 15–20% of primary colorectal cancers. MSI status is assessed to detect Lynch syndrome, guide adjuvant chemotherapy, determine prognosis, and use as a companion test for checkpoint blockade inhibitors. Traditionally, MSI status is determined by immunohistochemistry or molecular methods. The Idylla™ MSI Assay is a fully automated molecular method (including automated result interpretation), using seven novel MSI biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, SULF2) and not requiring matched normal tissue. In this real-world global study, 44 clinical centers performed Idylla™ testing on a total of 1301 archived colorectal cancer formalin-fixed, paraffin-embedded (FFPE) tissue sections and compared Idylla™ results against available results from routine diagnostic testing in those sites. MSI mutations detected with the Idylla™ MSI Assay were equally distributed over the seven biomarkers, and 84.48% of the MSI-high samples had ≥ 5 mutated biomarkers, while 98.25% of the microsatellite-stable samples had zero mutated biomarkers. The concordance level between the Idylla™ MSI Assay and immunohistochemistry was 96.39% (988/1025); 17/37 discordant samples were found to be concordant when a third method was used. Compared with routine molecular methods, the concordance level was 98.01% (789/805); third-method analysis found concordance for 8/16 discordant samples. The failure rate of the Idylla™ MSI Assay (0.23%; 3/1301) was lower than that of referenced immunohistochemistry (4.37%; 47/1075) or molecular assays (0.86%; 7/812). In conclusion, lower failure rates and high concordance levels were found between the Idylla™ MSI Assay and routine tests.

scholarly journals Cigarette Smoking and Colorectal Cancer Risk by KRAS Mutation Status Among Older Women

2012 ◽  
Vol 107 (5) ◽  
pp. 782-789 ◽  
Author(s):  
N J Samadder ◽  
Robert A Vierkant ◽  
Lori S Tillmans ◽  
Alice H Wang ◽  
Charles F Lynch ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Risk ◽  
Cigarette Smoking ◽  
Older Women ◽  
Kras Mutation ◽  
Colorectal Cancer Risk ◽  
Mutation Status ◽  
Kras Mutation Status

scholarly journals A Highly Verified Assay for KRAS Mutation Detection in Tissue and Plasma of Lung, Colorectal, and Pancreatic Cancer

2018 ◽  
Vol 143 (2) ◽  
pp. 183-189 ◽  
Author(s):  
Jing Li ◽  
Stephanie Gan ◽  
Alan Blair ◽  
Kyungji Min ◽  
Taraneh Rehage ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Kras Mutation ◽  
Analytical Sensitivity ◽  
Small Cell Lung ◽  
Kras Gene ◽  
Qualitative Detection ◽  
Formalin Fixed Paraffin ◽  
Mutant Sequence ◽  
Formalin Fixed Paraffin Embedded ◽  
Formalin Fixed

Context.— KRAS Mutation Test v2 is used for the qualitative detection and identification of 28 mutations in exons 2, 3, and 4 of the human KRAS gene. Objective.— To verify the performance of KRAS Mutation Test v2 and to evaluate its accuracy by correlation with a next-generation sequencing method on Illumina MiSeq. Design.— In this study, we used formalin-fixed, paraffin-embedded tissue and plasma specimens from non–small cell lung cancer, colorectal cancer, and pancreatic cancer patients. Results of specificity, precision, analytical sensitivity, and accuracy as compared with a MiSeq method are reported. Results.— The KRAS Mutation Test v2 demonstrated exquisite sensitivity and specificity and broad coverage of KRAS mutations. Precision was 100% (108 of 108) across all samples, operators, and instruments for formalin-fixed, paraffin-embedded tissue and 99.8% (615 of 616) for plasma. Analytical sensitivity was high with detection of 1% mutant sequence in formalin-fixed, paraffin-embedded tissue samples and as low as 25 mutant sequence copies/mL for plasma samples. The test also showed high overall concordance for formalin-fixed, paraffin-embedded tumor tissue as well as for plasma specimens when compared with MiSeq sequencing results. Conclusions.— The KRAS Mutation Test v2 is a highly robust, reproducible, and sensitive test for the qualitative detection of 28 mutations in exons 2, 3, and 4 of the KRAS gene in both solid (tissue) and liquid (plasma) biopsies from colorectal cancer, non–small cell lung cancer, and pancreatic cancer, and is a convenient option for KRAS mutation testing.

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