Spain; 8 centres; Testing mainly done in external laboratories Janssens 2014 Full journal Belgium EGFR mutation Data collection 107 samples Not specified Not specified Tissues Test failures article testing in from testing of tested collected TATO NSCLC patients in prospectively; clinical care by not archival two central tissue testing facilities Full journal EGFR mutation Retrospective 300 cases of Referrals from EGRM mutation Included Lim 2015 Canada Test failures article and ALK chart review of which focus was April 2010 – testing by PCR testing of Cases where rearrangement EGFR mutation on 258 cases of March 2013 fragment archival and repeat biopsies testing in and ALK non-squamous analysis; ALK new tissue; undertaken advanced rearrangement NSCLC of which testing by IHC 27/126 (21%) Cases where NSCLC testing of a 126 underwent confirmed by of results rebiopsy random sample diagnostic testing FISH available at provided of 25% of at the institution first adequate tissue patients with of which 99 consultation; for analysis advanced testing requests 99/126 TATO NSCLC in a were initiated by 978.65) not Biomarker the oncologist at available at single centre directed the initial initial treatment consultation (27 consultation management cases already had test results available) Fergusson 2009 Conference UK HER2 testing in Retrospective 49 cases Apr 2006-Apr Not specified Not specified TATO abstract breast cancer observation 2007 whether study of length testing was on of time of newly testing process; acquired, single centre archive tissue (tests or either undertaken centrally)
Spain; 8 centres; Testing mainly done in external laboratories Janssens 2014 Full journal article Belgium EGFR mutation testing in NSCLC Data collection from testing of patients in clinical care by two central testing facilities 107 samples tested Not specified Not specified Tissues collected prospectively; not archival tissue Test failures TATO Lim 2015 Full journal article Canada EGFR mutation and ALK rearrangement testing in advanced NSCLC Retrospective chart review of EGFR mutation and ALK rearrangement testing of a random sample of 25% of patients with advanced NSCLC in a single centre 300 cases of which focus was on 258 cases of non-squamous NSCLC of which 126 underwent diagnostic testing at the institution of which 99 testing requests were initiated by the oncologist at the initial consultation (27 cases already had test results available) Referrals from April 2010 – March 2013 EGRM mutation testing by PCR fragment analysis; ALK testing by IHC confirmed by FISH Included testing of archival and new tissue; 27/126 (21%) of results available at first consultation; 99/126 978.65) not available at initial consultation Test failures Cases where repeat biopsies undertaken Cases where rebiopsy provided adequate tissue for analysis TATO Biomarker directed treatment management Fergusson 2009 Conference abstract UK HER2 testing in breast cancer Retrospective observation study of length of time of testing process; single centre (tests undertaken centrally) 49 cases Apr 2006-Apr 2007 Not specified Not specified whether testing was on newly acquired, archive tissue or either TATO
1331-Contracted_Assessment_Report-accessible.docx