2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK UCL-Advanced Diagnostics 1st Floor, Rockefeller Building 21 University Street London WC1E 6JJ Contact: David Allen Tel: +44 (0)20 7679 6912 Fax: +44 (0)20 7679 6275 E-Mail: david.allen@ucl.ac.uk Website: http://www.uclad.com Testing performed at the above address only DETAIL OF ACCREDITATION tissue Histological examinations for the purpose of clinical diagnosis Macroscopic and Microscopic examination using in house procedures in conjunction with manufacturer s instructions for the following methods (where relevant): Tissue Re-Embedding IHC LP1 Re-embedding of tissue using the Leica EG1150H embedding centre and cold plate Microtomy IHC LP1 Tissue sectioning using Leica RM2235 microtomes tissue Basophilic and eosinophilic structures Immunohistochemistry stained tissue with subsequent analysis by an accredited laboratory for the epitopes listed: 34BE12 ACTH Haematoxylin and Eosin stain IHC LP25 Automated H&E staining using the Leica XL Autostainer Coverslipping of glass slides IHC LN1- Coverslipping of glass slides using the ClearVue coverslipper using Leica Bond III, Ventana/Roche XT & Ultra and Dako Autostainer 48 platforms Immunohistochemistry Automated methods using: IHC LP4, 24, IHC LN 6, 10, 13, 14 Assessment Manager: JP Page 1 of 13
tissue AE1/AE3 AFP ALK (D5F3) ALK (5A4) AMACR (Racemase) AMACR/p63 cocktail Androgen Receptor Bcl-2 Bcl-6 BerEP4 Beta-catenin BOB-1 CA125 CA19.9 CA-IX Calcitonin Calponin Calretinin CAM 5.2 CD10 CD103 CD117 CD11c Ventana XT/Ultra, IHC Assessment Manager: JP Page 2 of 13
tissue CD123 CD138 CD14 CD15 CD16 CD163 CD19 CD1a CD2 CD20 CD21 CD22 CD23 CD235a CD25 CD3 CD30 CD31 CD33 CD34 CD38 CD4 Assessment Manager: JP Page 3 of 13
tissue CD43 CD45 CD45RO CD5 CD56 CD57 CD61 CD68(KP1) CD68(PGM1) CD7 CD79a CD8 CD99 CDX-2 CEA polyclonal CEA Chromogranin A CK14 CK17 CK19 CK20 CK5 Assessment Manager: JP Page 4 of 13
tissue CK7 CK8 CMV c-myc Collagen IV COX-2 Cyclin D1 D240 DBA44 Desmin DOG-1 E cadherin EBV EGFR (C36) EGFR E746-A750 EGFR L858R EMA ER (6F11) ER (EP1) ERG Factor VIII Factor XIIIa Ventana Ultra, IHC Ventana XT, IHC Ventana XT, IHC Ventana Ultra, IHC Assessment Manager: JP Page 5 of 13
tissue Fascin FSH Galectin 3 Gastrin GATA3 GCDFP-15 GFAP GH Glucagon Glycophorin C Glypican 3 Granzyme B H pylori Haemoglobin HBME-1 h-caldesmon HCG Her-2 HMA (MSA) HMB45 HSA (HepPar1) HSVI/HSVII cocktail Ventana Ultra, IHC Assessment Manager: JP Page 6 of 13
tissue IDH-1 IgA IgD IgG IgM Inhibin Insulin Kappa (various dilutions) KSHV (HHV-8) Lambda (various dilutions) Lysozyme Mast cell tryptase Melan A Mesothelin MIB-1 mlh1 MNF116 MOC31 MSH2 MSH6 MUC-5AC MUC-1 Assessment Manager: JP Page 7 of 13
tissue MUC-2 MUC-4 MUC-6 MUM-1 Myeloperoxidase MYO D1 Myogenin Myoglobin Napsin A Neurofilament Neutrophil elastase NSE OCT-2 OCT-3/4 p16 INK4a p40 p53 p57 p63 Parvovirus B19 PAX-2 PAX-8 Ventana Ultra, IHC Assessment Manager: JP Page 8 of 13
tissue PD-L1 (22C3) Perforin PGP 9.5 PLAP PMS2 PR Prolactin Prostein (P501s) PSA PSAP PTEN RCC S100 SALL4 Serotonin SMA SMM Somatostatin SOX-10 SOX-11 STAT6 Synaptophysin Dako Autostainer Link 48, IHC Assessment Manager: JP Page 9 of 13
tissue TAL1B5 (HLA-DR) Tdt Thyroglobulin TRAP TSH TTF-1 Uroplakin III Villin Vimentin VS38c VZV WT1 ZAP 70 Assessment Manager: JP Page 10 of 13
tissue In-situ hybridisation stained tissue with subsequent analysis by an ISO 15189:2012 accredited laboratory to detect the presence or absence of targets listed: CMV Automated in-situ hybridisation using Leica Bond III and Ventana/Roche Ultra platforms In-situ hybridisation Automated methods using: IHC LP4, 24 IHC LN6, 10, 13, 14 Leica Bond III, CISH EBER HPV Family 16 HPV Family 6 Kappa Lambda Leica Bond III, CISH Ventana Ultra, CISH Ventana Ultra, CISH Leica Bond III, CISH Leica Bond III, CISH Assessment Manager: JP Page 11 of 13
tissue In-situ hybridisation stained tissue with subsequent analysis by an ISO 15189:2012 accredited laboratory to detect the presence or absence of targets listed: ALK breakapart BCL2 breakapart BCL2:IGH fusion BCL6 breakapart CCND1 breakapart FGFR1 amplification FGFR2 amplification FGFR2 breakapart HER2 amplification IGH breakapart MALT breakapart Melanoma FISH MET amplification MYC breakapart MYC:IGH fusion ROS1 breakapart Semi-automated fluorescent in-situ hybridisation using Abbott Molecular VP2000 platform Interpretation by manual fluorescent microscopy and semi-automated BioView system Fluorescent in-situ hybridisation Semi-automated methods using: IHC LP19; IHC LN2, 16, 20, 23 VP2000, Manual Reporting Assessment Manager: JP Page 12 of 13
tissue Morphological assessment and interpretation/diagnosis limited to the following antigenic targets: ALK IHC Her-2 IHC ER IHC PR IHC p16 IHC HPV ISH; high & low risk EGFR IHC EGFR Mutation specific IHC MMR (MisMatch Repair) IHC PD-L1 (22C3) IHC Microscopy (qualitative analysis) and reporting Morphological and immunohistochemistry.in-situ hybridisation assessment of tissue UCLAD MF44 UCLAD QF21, 22, 23, 24, 26 Clinical interpretation of CISH by END Assessment Manager: JP Page 13 of 13