Table Summary of observation studies of single molecular diagnostic testing undertaken as a requested or routine pathology service with a view of treatment management Lead Diagnostic test Context of Data Use of Outcomes Citation type Country Test method(s) author/Year and test study collection archive reported population tissues potentially relevant to this submission Bibeau 2010a,b,c Conference France KRAS mutation A retrospective 575 samples Tests between Not reported Reviewed Test failures abstract testing in mCRC one year May 2008-May archival FFPE observation 2009 tissues; study of KRAS mutation testing in clinical practice Ciardiello 2011 Full journal Europe (6 KRAS mutation Yearly 2008: 113 tests Survey years: Not reported Not specified TATO article countries); Latin testing in mCRC survey 2008-2010 whether 2009: 1775 tests Test failures America (5 (quantitative testing was on 2010: 2619 tests countries); Asia questionnaire of newly (2 countries) physicians acquired, including review archive tissue of the records of or either 4 a priori designated mCRC patients (last seen, last seen in first, second and third line settings) Full journal KRAS mutation Testing Mostly RT-PCR; Testing was Bibeau 2012 France 329 patients TATO article testing in mCRC undertaken sequencing; on primary Test failures study of access Oct 2008-Oct pyrosequencing tissue and to KRAS surgical 2009 mutation testing samples of patients with mCRC across 66 institutions
Table Summary of observation studies of single molecular diagnostic testing undertaken as a requested or routine pathology service with a view of treatment management Lead author/Year Citation type Country Diagnostic test and test population Context of study Data collection Test method(s) Use of archive tissues Outcomes reported potentially relevant to this submission Bibeau 2010a,b,c Conference abstract France KRAS mutation testing in mCRC A retrospective one year observation study of KRAS mutation testing in clinical practice 575 samples Tests between May 2008-May 2009 Not reported Reviewed archival FFPE tissues; Test failures Ciardiello 2011 Full journal article Europe (6 countries); Latin America (5 countries); Asia (2 countries) KRAS mutation testing in mCRC Yearly survey (quantitative questionnaire of physicians including review of the records of 4 a priori designated mCRC patients (last seen, last seen in first, second and third line settings) 2008: 113 tests 2009: 1775 tests 2010: 2619 tests Survey years: 2008-2010 Not reported Not specified whether testing was on newly acquired, archive tissue or either TATO Test failures Bibeau 2012 Full journal article France KRAS mutation testing in mCRC study of access to KRAS mutation testing of patients with mCRC across 66 institutions 329 patients Testing undertaken Oct 2008-Oct 2009 Mostly RT-PCR; sequencing; pyrosequencing Testing was on primary tissue and surgical samples TATO Test failures
1331-Contracted_Assessment_Report-accessible.docx