TY - JOUR
T1 - BRAF mutation testing with a rapid, fully integrated molecular diagnostics system
AU - Janku, Filip
AU - Claes, Bart
AU - Huang, Helen J.
AU - Falchook, Gerald S.
AU - Devogelaere, Benoit
AU - Kockx, Mark
AU - Bempt, Isabelle Vanden
AU - Reijans, Martin
AU - Naing, Aung
AU - Fu, Siqing
AU - Piha-Paul, Sarina A.
AU - Hong, David S.
AU - Holley, Veronica R.
AU - Tsimberidou, Apostolia M.
AU - Stepanek, Vanda M.
AU - Patel, Sapna P.
AU - Kopetz, E. Scott
AU - Subbiah, Vivek
AU - Wheler, Jennifer Jane
AU - Zinner, Ralph G
AU - Karp, Daniel D.
AU - Luthra, Rajyalakshmi
AU - Roy-Chowdhuri, Sinchita
AU - Sablon, Erwin
AU - Meric-Bernstam, Funda
AU - Maertens, Geert
AU - Kurzrock, Razelle
PY - 2015
Y1 - 2015
N2 - Fast and accurate diagnostic systems are needed for further implementation of precision therapy of BRAF-mutant and other cancers. The novel IdyllaTM 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 CLIAcertified 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 IdyllaTM 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.
AB - Fast and accurate diagnostic systems are needed for further implementation of precision therapy of BRAF-mutant and other cancers. The novel IdyllaTM 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 CLIAcertified 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 IdyllaTM 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.
KW - BRAF
KW - Integrated
KW - Rapid
KW - qPCR
UR - http://www.scopus.com/inward/record.url?scp=84944463600&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84944463600&partnerID=8YFLogxK
U2 - 10.18632/oncotarget.4723
DO - 10.18632/oncotarget.4723
M3 - Article
C2 - 26330075
AN - SCOPUS:84944463600
SN - 1949-2553
VL - 6
SP - 26886
EP - 26894
JO - Oncotarget
JF - Oncotarget
IS - 29
ER -