Download The Institute of Cancer Research

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