65
Chapter 9: Guidelines and Standardization Studies
candidate for treatment with an ALK inhibitor based on the results of both IHC and FISH, there may be discrepancy between the results of the two tests, and treatment should be determined with careful consideration of the benefit-risk profile (Mitsudomi 2011). France The French National Cancer Institute (INCa) program, started in 2007, is devoted to the prospective detection of emerging biomarkers in lung cancer, colorectal cancer, and melanoma in 28 hospitalbased molecular genetics platforms for cancers. As a part of this program, the French multicenter ALK validation study is being conducted to compare IHC, using 5A4 and D5F3 antibodies (Novocastra, and Cell Signaling Technology, respectively), with FISH and quantita F?fR%B?5"??6W&?W2?bSdeR7W&v?6?7V6??V?2???G\:???V?#2?????rF?RCS?7V6??V?2??6?VFVBF?FFR?3CvW&R??VvF?fR??&?F?d?4??B??2?B?RvW&R??6?F?fR??&?F?d?4??B??2????rF?RF?66?&F?B66W2?RvW&R?VvF?fR??d?4??B?6?F?fR????2?'WBv?F???r7F????r66?&W2??"vW&R?6?F?fR??d?4??B?VvF?fR????2?6WfV?7V6??V?2vW&R?????FW'&WF&?R'?d?4??'WBf?fR?bF?V?vW&R??6?F?fR????2??fW&???F?R6V?6?F?f?G??b??2fW'7W2d?4?v2?rR??BF?R7V6?f?6?G?v2?bR???V?F?FF?fR%B?5"????7BSR?b???6?F?fR7V6??V?2?Bf&??B?3R?Bf&??B6?"??B?W72F??RR?Bf&??B"?"s?#RvW&R?VvF?fR?"?????FW'&WF&?R?F?RWF??'26??6?VFVBF?B??2v?F?TB?2&V?&?R?BV7?FV6???VRf?"&?WF??RF?v??6?2?b?&??&??F?W2?v?W&V2d?4??BV?F?FF?fR%B?5"7F???FWV?B??&V??F?26??F?F???2?BFV6???6?W?W'F?6R???vWfW"????WF??B?2'6??WFV?67W&FR??Bv?V?F?R6???6?&W6V?FF????27VvvW7F?fR?b??6?F?f?G??FW7?FR?VvF?fRFW7B&W7V?B?&WVBFW7F??rv?F???F?W"?WF??B&WfV?G2?76??rF?V?Bv???2????6?F?fRGV??"?vW&???F?RvW&??6?6?WG??bF????w??FWWG66?RvW6V??66?gBl;?"F????v?S?Du??BF?R&?fW76????76?6?F????bvW&??F????v?7G2?&W'Vg7fW&&?BFWWG66?W"F????v?S?$E?&R6??GV7F??r&?V?B?&?&??FW7G2f?"F?RFWFV7F????b?gW6???F?6W'F?f??F?RFV6???VR????F?f?GV???7F?GWFW2???F?R&WFW7F??r?6R?bF?R7GVG??7V6??V?2g&???V?r6?6W"66W2vW&RWf?VFVB'?W?W'G2BV?v?B??7F?GWFW2?bF????w?F?6??f?&?F?R?7FGW2v?F?W6R?bd?4??B??2FW7F??r?b?ffW'B#2??F?V??F?R6??f?&?VB?V?r6?6W"6??W2vW&RF?7G&?'WFVB2F?77VR?7&?'&?6V7F????F?R'F?6?F??r??7F?GWFW2W6VBF?ffW&V?Bd?4?&?&W2?g&??V?F?W"&&?GB???V7V?"?"??F?f?6???v?$????F?&?G?6???W2???TB??BCTc2??F??WF???2??#F??#???BFWFV7F???7?7FV????V??"WF??FVB7F??W"g&??fV?F??VF?6?7?7FV?2??V?6&??7?7FV?2??"F??????VvF?fRGV??'2vW&R6?'&V7F?F?v??6VBv?F?V?F?W"?WF??B?d?4??B??2??v?W&V2F?fW'6R&W7V?G2vW&Rf?V?Bf?"???6?F?fRGV??'2?W7V6???v?F???2?F?R7GVG?6?V&?6??vVBF?B?B?27'V6??F?W7F&?6?7F?F&F??VB&?F?6??2F?FWFV7BF?R?gW6???vV?R?WW&?RwV?FV??R??F?R&WV?&V?V?G2?bW?FW&??V?G?76W76?V?B&?w&?2f?"???V7V?"F????w?v2&V6V?F?V&?6?VB?f??&?V?V?#2??F?RWW&?V?6?6?WG??bF????w?6??GV7G2WW&?V?W?FW&??V?G?76W76?V?B&?w&?f?"FW7F??r&???&?W"?WFF???2???44?2?F?V?7W&R?F???67W&7??B&?f?6?V?7???&???&?W"FW7F??r?F?R&?w&?66?V?G2f?"Gv?W?FW&??V?G?76W76?V?B&?V?G2f?"?FW7F??r???v??6???BS?&?&F?&?W2'F?6?FVB?F?77VR?7&?'&?6?FP??