Table Summary of single biomarker testing undertaken as part of diagnostic test method development, assessment of test performance or tumour characterisation for research purposes Lead Citation type Country Diagnostic test Context/Study Date Test method(s) Tissue Outcomes author/Year type source reported potentially relevant to this submission Van Cutsem Conference Multi-national KRAS mutation Retrospective 578 of 1198 Not reported Mutation specific Archive tissue Test failures 2008 abstract testing in mCRC study of KRAS randomised quantitative PCR used mutation status of patients patients in the CRYSTAL trial of cetuximab Carotenuto Full journal KRAS mutation Test method RT-PCR; FFPE tissues; Italy 540 samples Not specified Test failures 2010 article testing in CRC development for sequencing Not specified use in clinical whether practice testing was on newly acquired, archive tissue or either Dantes 2010 Conference Germany KRAS mutation Retrospective 274 Cases Resections Tissue microarray Archive FFPE Test failures abstract testing in mCRC testing of patients between 1993 analysis; tissue from with CRC; single mutation directed primary centre study analysis tumour Abdulkareem Conference UK KRAS and Retrospective 200 cases Not reported Pyrosequencing Archive FFPE Test failures 2012a and b abstract/ BRAF mutation testing of patients tumour tissue analysis in with CRC; single Full journal Nigerian CRC centre study article Spigel 2010 Conference US EGFR and Retrospective 128 patients Not reported Not reported Archive tissue Test failures abstract KRAS mutation testing of patients analysis in included in a NSCLC clinical trial Morgan 2011 Conference Multi-national EGFR and Re-evaluation of 146 samples Not reported DxS ARMS Kit Archival Test failures abstract KRAS mutation archival tissue biopsy analysis in previously
Table Summary of single biomarker testing undertaken as part of diagnostic test method development, assessment of test performance or tumour characterisation for research purposes Lead author/Year Citation type Country Diagnostic test Context/Study type Date Test method(s) Tissue source Outcomes reported potentially relevant to this submission Van Cutsem 2008 Conference abstract Multi-national KRAS mutation testing in mCRC Retrospective study of KRAS mutation status of patients in the CRYSTAL trial of cetuximab 578 of 1198 randomised patients Not reported Mutation specific quantitative PCR Archive tissue used Test failures Carotenuto 2010 Full journal article Italy KRAS mutation testing in CRC Test method development for use in clinical practice 540 samples Not specified RT-PCR; sequencing FFPE tissues; Not specified whether testing was on newly acquired, archive tissue or either Test failures Dantes 2010 Conference abstract Germany KRAS mutation testing in mCRC Retrospective testing of patients with CRC; single centre study 274 Cases Resections between 1993 Tissue microarray analysis; mutation directed analysis Archive FFPE tissue from primary tumour Test failures Abdulkareem 2012a and b Conference abstract/ Full journal article UK KRAS and BRAF mutation analysis in Nigerian CRC Retrospective testing of patients with CRC; single centre study 200 cases Not reported Pyrosequencing Archive FFPE tumour tissue Test failures Spigel 2010 Conference abstract US EGFR and KRAS mutation analysis in NSCLC Retrospective testing of patients included in a clinical trial 128 patients Not reported Not reported Archive tissue Test failures Morgan 2011 Conference abstract Multi-national EGFR and KRAS mutation analysis in Re-evaluation of archival tissue previously 146 samples Not reported DxS ARMS Kit Archival biopsy Test failures