BRAF mutation testing with a rapid, fully integrated molecular diagnostics system
Fast and accurate diagnostic systems are needed for further implementation of precision therapy of BRAF-mutant and other cancers. The novel IdyllaTMBRAF Mutation Test has high sensitivity and shorter turnaround times compared to other methods. We used Idylla to detect BRAF V600 mutations in archived...
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Published in | Oncotarget Vol. 6; no. 29; pp. 26886 - 26894 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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Impact Journals LLC
29.09.2015
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Abstract | Fast and accurate diagnostic systems are needed for further implementation of precision therapy of BRAF-mutant and other cancers. The novel IdyllaTMBRAF Mutation Test has high sensitivity and shorter turnaround times compared to other methods. We used Idylla to detect BRAF V600 mutations in archived formalin-fixed paraffin-embedded (FFPE) tumor samples and compared these results with those obtained using the cobas 4800 BRAF V600 Mutation Test or MiSeq deep sequencing system and with those obtained by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory employing polymerase chain reaction-based sequencing, mass spectrometric detection, or next-generation sequencing. In one set of 60 FFPE tumor samples (15 with BRAF mutations per Idylla), the Idylla and cobas results had an agreement of 97%. Idylla detected BRAF V600 mutations in two additional samples. The Idylla and MiSeq results had 100% concordance. In a separate set of 100 FFPE tumor samples (64 with BRAF mutation per Idylla), the Idylla and CLIA-certified laboratory results demonstrated an agreement of 96% even though the tests were not performed simultaneously and different FFPE blocks had to be used for 9 cases. The IdyllaTMBRAF Mutation Test produced results quickly (sample to results time was about 90 minutes with about 2 minutes of hands on time) and the closed nature of the cartridge eliminates the risk of PCR contamination. In conclusion, our observations demonstrate that the Idylla test is rapid and has high concordance with other routinely used but more complex BRAF mutation-detecting tests. |
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AbstractList | Fast and accurate diagnostic systems are needed for further implementation of precision therapy of
BRAF-
mutant and other cancers. The novel Idylla
TM
BRAF
Mutation Test has high sensitivity and shorter turnaround times compared to other methods. We used Idylla to detect
BRAF
V600 mutations in archived formalin-fixed paraffin-embedded (FFPE) tumor samples and compared these results with those obtained using the cobas 4800
BRAF
V600 Mutation Test or MiSeq deep sequencing system and with those obtained by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory employing polymerase chain reaction–based sequencing, mass spectrometric detection, or next-generation sequencing. In one set of 60 FFPE tumor samples (15 with
BRAF
mutations per Idylla), the Idylla and cobas results had an agreement of 97%. Idylla detected
BRAF
V600 mutations in two additional samples. The Idylla and MiSeq results had 100% concordance. In a separate set of 100 FFPE tumor samples (64 with
BRAF
mutation per Idylla), the Idylla and CLIA-certified laboratory results demonstrated an agreement of 96% even though the tests were not performed simultaneously and different FFPE blocks had to be used for 9 cases. The Idylla
TM
BRAF
Mutation Test produced results quickly (sample to results time was about 90 minutes with about 2 minutes of hands on time) and the closed nature of the cartridge eliminates the risk of PCR contamination. In conclusion, our observations demonstrate that the Idylla test is rapid and has high concordance with other routinely used but more complex
BRAF
mutation–detecting tests. Fast and accurate diagnostic systems are needed for further implementation of precision therapy of BRAF-mutant and other cancers. The novel IdyllaTMBRAF Mutation Test has high sensitivity and shorter turnaround times compared to other methods. We used Idylla to detect BRAF V600 mutations in archived formalin-fixed paraffin-embedded (FFPE) tumor samples and compared these results with those obtained using the cobas 4800 BRAF V600 Mutation Test or MiSeq deep sequencing system and with those obtained by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory employing polymerase chain reaction-based sequencing, mass spectrometric detection, or next-generation sequencing. In one set of 60 FFPE tumor samples (15 with BRAF mutations per Idylla), the Idylla and cobas results had an agreement of 97%. Idylla detected BRAF V600 mutations in two additional samples. The Idylla and MiSeq results had 100% concordance. In a separate set of 100 FFPE tumor samples (64 with BRAF mutation per Idylla), the Idylla and CLIA-certified laboratory results demonstrated an agreement of 96% even though the tests were not performed simultaneously and different FFPE blocks had to be used for 9 cases. The IdyllaTMBRAF Mutation Test produced results quickly (sample to results time was about 90 minutes with about 2 minutes of hands on time) and the closed nature of the cartridge eliminates the risk of PCR contamination. In conclusion, our observations demonstrate that the Idylla test is rapid and has high concordance with other routinely used but more complex BRAF mutation-detecting tests. |
Author | Claes, Bart Wheler, Jennifer J Devogelaere, Benoit Hong, David S Piha-Paul, Sarina A Kurzrock, Razelle Zinner, Ralph G Janku, Filip Bempt, Isabelle Vanden Patel, Sapna P Subbiah, Vivek Naing, Aung Fu, Siqing Kopetz, E Scott Holley, Veronica R Karp, Daniel D Luthra, Rajyalakshmi Huang, Helen J Roy-Chowdhuri, Sinchita Sablon, Erwin Tsimberidou, Apostolia M Falchook, Gerald S Reijans, Martin Stepanek, Vanda M Meric-Bernstam, Funda Kockx, Mark Maertens, Geert |
AuthorAffiliation | 6 Molecular Diagnostics Laboratory, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA 7 Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA 4 Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA 3 Sarah Cannon Research Institute at HealthONE, Denver, CO 80218, USA 8 Center for Personalized Cancer Therapy, Moores Cancer Center, The University of California San Diego, La Jolla, CA 92093, USA 9 Cartagenia, 3001 Leuven, Belgium 2 Biocartis NV, 2800 Mechelen, Belgium 5 Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA 1 Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA 10 HistoGeneX NV, 2600 Berchem, Belgium |
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Author_xml | – sequence: 1 givenname: Filip surname: Janku fullname: Janku, Filip organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 2 givenname: Bart surname: Claes fullname: Claes, Bart organization: Biocartis NV, 2800 Mechelen, Belgium – sequence: 3 givenname: Helen J surname: Huang fullname: Huang, Helen J organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 4 givenname: Gerald S surname: Falchook fullname: Falchook, Gerald S organization: Sarah Cannon Research Institute at HealthONE, Denver, CO 80218, USA – sequence: 5 givenname: Benoit surname: Devogelaere fullname: Devogelaere, Benoit organization: Cartagenia, 3001 Leuven, Belgium – sequence: 6 givenname: Mark surname: Kockx fullname: Kockx, Mark organization: HistoGeneX NV, 2600 Berchem, Belgium – sequence: 7 givenname: Isabelle Vanden surname: Bempt fullname: Bempt, Isabelle Vanden organization: HistoGeneX NV, 2600 Berchem, Belgium – sequence: 8 givenname: Martin surname: Reijans fullname: Reijans, Martin organization: Biocartis NV, 2800 Mechelen, Belgium – sequence: 9 givenname: Aung surname: Naing fullname: Naing, Aung organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 10 givenname: Siqing surname: Fu fullname: Fu, Siqing organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 11 givenname: Sarina A surname: Piha-Paul fullname: Piha-Paul, Sarina A organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 12 givenname: David S surname: Hong fullname: Hong, David S organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 13 givenname: Veronica R surname: Holley fullname: Holley, Veronica R organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 14 givenname: Apostolia M surname: Tsimberidou fullname: Tsimberidou, Apostolia M organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 15 givenname: Vanda M surname: Stepanek fullname: Stepanek, Vanda M organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 16 givenname: Sapna P surname: Patel fullname: Patel, Sapna P organization: Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 17 givenname: E Scott surname: Kopetz fullname: Kopetz, E Scott organization: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 18 givenname: Vivek surname: Subbiah fullname: Subbiah, Vivek organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 19 givenname: Jennifer J surname: Wheler fullname: Wheler, Jennifer J organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 20 givenname: Ralph G surname: Zinner fullname: Zinner, Ralph G organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 21 givenname: Daniel D surname: Karp fullname: Karp, Daniel D organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 22 givenname: Rajyalakshmi surname: Luthra fullname: Luthra, Rajyalakshmi organization: Molecular Diagnostics Laboratory, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 23 givenname: Sinchita surname: Roy-Chowdhuri fullname: Roy-Chowdhuri, Sinchita organization: Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 24 givenname: Erwin surname: Sablon fullname: Sablon, Erwin organization: Biocartis NV, 2800 Mechelen, Belgium – sequence: 25 givenname: Funda surname: Meric-Bernstam fullname: Meric-Bernstam, Funda organization: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA – sequence: 26 givenname: Geert surname: Maertens fullname: Maertens, Geert organization: Biocartis NV, 2800 Mechelen, Belgium – sequence: 27 givenname: Razelle surname: Kurzrock fullname: Kurzrock, Razelle organization: Center for Personalized Cancer Therapy, Moores Cancer Center, The University of California San Diego, La Jolla, CA 92093, USA |
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Snippet | Fast and accurate diagnostic systems are needed for further implementation of precision therapy of BRAF-mutant and other cancers. The novel IdyllaTMBRAF... Fast and accurate diagnostic systems are needed for further implementation of precision therapy of BRAF- mutant and other cancers. The novel Idylla TM BRAF... |
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SubjectTerms | DNA Mutational Analysis - methods Formaldehyde - chemistry High-Throughput Nucleotide Sequencing Humans Melanoma - diagnosis Melanoma - genetics Melanoma - metabolism Mutation Neoplasms - diagnosis Neoplasms - genetics Neoplasms - metabolism Paraffin Embedding Pathology, Molecular Proto-Oncogene Proteins B-raf - genetics Real-Time Polymerase Chain Reaction Reproducibility of Results Research Paper Skin Neoplasms - diagnosis Skin Neoplasms - genetics Skin Neoplasms - metabolism |
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Title | BRAF mutation testing with a rapid, fully integrated molecular diagnostics system |
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