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Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK The Institute of Cancer Research Issue No: 003 Issue date: 24 January 2017 8206 Accredited to ISO 15189:2012 TGLclinical Contact: Ann Strydom Brookes Lawley Building Tel: +44 (0) 2073528133 Institute of Cancer Research Fax: +44 (0) 2073705261 15 Cotswold Road E-Mail: [email protected] Sutton Website: www.icr.ac.uk Surrey SM2 5NG Testing performed at the above address only DETAIL OF ACCREDITATION Materials/Products tested Type of test/Properties measured/Range of measurement Standard specifications/ Equipment/Techniques used HUMAN BODY FLUIDS Molecular Genetics Tests Documented In-house Methods Human genomic DNA extracted from blood in EDTA or Oragene saliva samples Tests for mutations in the full BRCA1 and BRCA2 genes causing susceptibility to cancer. Presence or absence of disease causing variants in the genomic DNA is tested. Genomic DNA extracted from blood using ChemagicSTAR or manual extraction, or genomic DNA extracted from Oragene saliva samples. M13 PCR and sequencing and MLPA performed on PCR machines, and analysed on ABI3730 TruSight sample prep is carried out using PCR machines and TruSight sequencing carried out on illumina HiSeq2500 Sanger sequencing or illumina TruSight and MLPA. Procedures: TGL_S_03_Chemagic Star Extraction TGL_S_11_Chemagen DNA Extraction TGL_S_09_PCR & Sanger Seq TGL_S_05_MLPA TGL_S_10_Specific_Mutation_Testi ng TGL_S_13_MLPA_Analysis TGL_S_18_PCR & Sanger_Sequencing_Analysis TGL_S_24_TruSightCancer_Library _Prep TGL_S_25_HiSeq2500_Rapid_Seq uencing TGL_Q_30 _Cancer predisposition gene testing Assessment Manager: rc4 Page 1 of 2 S c he dul e of Ac c r e di ta ti on issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Stai nes -upon-Tham es, TW 18 3HR, UK The Institute of Cancer Research 8206 Accredited to ISO 15189:2012 Issue No: 003 Issue date: 24 January 2017 Testing performed at main address only Materials/Products tested Type of test/Properties measured/Range of measurement Standard specifications/ Equipment/Techniques used HUMAN BODY FLUIDS (cont’d) Molecular Genetics Tests (cont’d) Documented In-house Methods Human genomic DNA extracted from blood in EDTA or Oragene saliva samples (cont’d) Tests for mutations in the full BRCA1 and BRCA2 genes causing susceptibility to cancer. Presence or absence of disease causing variants in the lymphocyte genomic DNA is tested. (cont’d) Test Validation: Validation ChemagicSTAR DNA Extractor Validation BRCA1&2 mpx sequencing Validation M13 sequencing Validation BRCA1&2 MLPA Validation TruSight_BRCA1&2 Specific mutation testing. Presence or absence of familial mutation is tested on genomic DNA. M13 tagged PCR and sequencing and MLPA Procedures: TGL_S_03_Chemagic Star Extraction TGL_S-11 Chemagen Extraction TGL_S_09_PCR & Sanger Seq TGL_S_10_Specific_Mutation_Testi ng TGL_S_13_MLPA_Analysis TGL_S_18_PCR & Sanger _Sequencing_Analysis TGL_Q_30 _Cancer predisposition gene testing Test Validation : ChemagicSTAR DNA Extractor Validation BRCA1&2 M13 sequencing Validation BRCA1&2 MLPA Test for mutations in Cancer Predisposition Genes using the Illumina NGS TruSight Cancer Panel (TSCP). Genomic DNA extracted from blood using ChemagicSTAR (or Chemagen extraction Genomic DNA extracted from saliva using Oragene Targeted NGS using TruSight Rapid Capture library preparation and TruSight Cancer Panel (TSCP) is carried out on PCR machines and HiSeq 2500 sequencing systems. Main document: TGL_Q_30_Cancer_Predisposition _Gene_Testing Human body fluids – human genomic DNA extracted from blood in EDTA or Oragene saliva samples END Assessment Manager: rc4 Page 2 of 2
