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Hellenic Accreditation System
Annex G1/9 to the Certificate No. 822-5
SCOPE of ACCREDITATION
of the
Clinical laboratory
of
“GENEKOR Medical S.A.”
Materials/Products tested
Types of test/Properties measured
Applied methods/Techniques
used
Molecular Genetics
1. Peripheral blood
1.Mutation detection in BRCA1 & BRCA2 genes Multiplex PCR with BRCA
(Breast Cancer susceptibility genes 1 and 2)
MASTR Dx CE-IVD kit
(Multiplicom N.V.) and Next
(Full coding sequence, splice sites and flanking
Generation Sequencing (NGS)
intronic sequences)
with MiSeq (Illumina)
2. Single mutation identification or confirmation in
DNA sequencing by capillary
BRCA1 & BRCA2 genes
electrophoresis with ABI 3130
Genetic Analyser, (Applied
Biosystems)
2. Peripheral blood
1. Mutation Detection in a Cancer Gene Panel with Multiplex PCR with BRCA
focus on BRCA1, BRCA2 genes (Breast Cancer Hereditary Cancer MASTR
susceptibility genes 1 and 2)
Plus kit (Multiplicom N.V.) and
Next Generation Sequencing
(NGS) with MiSeq (Illumina)
3. Peripheral blood
1. Detection of genomic rearrangements in BRCA1 Multiplex Ligation-Dependent
and BRCA2 genes by Multiplex Ligation- Probe Amplification (MLPA)
Dependent Probe Amplification (MLPA)
(SALSA MLPA Probemix,
MRC-Holland)
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Annex G1/9 to the Certificate ESYD No. 822-5
06.04.2017
Materials/Products tested
Types of test/Properties measured
Applied methods/Techniques
used
4. Peripheral blood
1. Mutation Detection in a Cancer Gene Panel with SeqCap
EZ
focus on BRCA1 & 2 genes (Breast Cancer NimbleGen, Roche
susceptibility genes 1 and 2) using a solution based
capture approach and next generation sequencing
5.Paraffin-embedded
tissue, cytology specimens
1. Somatic mutation detection in exons 18, 19, 20,
21 of EGFR gene
2. Somatic mutation detection in exons 2, 3, 4 of
KRAS and NRAS genes
Choice,
In-house method with Ion
AmpliSeq™ Panel primers
(Thermo Fisher Scientific) and
Next Generation Sequencing
(NGS) with Ion Proton
(Thermo Fisher Scientific)
3. Somatic mutation detection in exons 11 and 15 of
BRAF gene
4. Somatic mutation detection in exons 9, 11, 13 and
17 of KIT gene
5. Somatic mutation detection in exons 12, 14 and
18 of PDGFRA gene
6. Somatic mutation detection in exons 2 and 3 of
HRAS gene
6. Paraffin embedded
tissue, peripheral blood,
buccal swab
1. Detection of DNA Microsatellite Instability
(MSI)
7. Paraffin embedded
tissue
1. Detection and quantification of the ALK gene Chromogenic in situ
rearrangements
hybridization (CISH) with
ZytoVision CE-IVD kit,
(ZytoDot SPEC ALK Break
Apart Probe and ZytoDot 2C
CISH Implementation Kit)
8. Paraffin embedded
tissue
1. Detection and quantification
overexpression of the HER2/NEU gene
9. Paraffin embedded
tissue
1. Detection and quantification of the ALK gene
rearrangements
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Annex G1/9 to the Certificate ESYD No. 822-5
In-house multiplex fluorescent
PCR method in five
microsatellite loci and
fragment analysis by capillary
electrophoresis with ABI 3130
Genetic Analyser, (Applied
Biosystems)
the Chromogenic in situ
hybridization (CISH) with
ZytoVision CE-IVD kit,
(ZytoDot 2C SPEC
ERBB2/CEN 17 Probe KIT)
Fluorescent in situ
hybridization (FISH) with
ZytoVision CE-IVD kit
(ZytoLight SPEC ALK Dual
Color Break Apart Probe and
ZytoLight FISH Tissue
Implementation Kit)
06.04.2017
Materials/Products tested
10. Paraffin embedded
tissue
Types of test/Properties measured
1. Detection and quantification of the
overexpression of the HER2/NEU gene
Applied methods/Techniques
used
Fluorescent in situ
hybridization (FISH) with
ZytoVision CE-IVD kit
(ZytoLight SPEC
ERBB2/CEN17 Dual Color
Probe and ZytoLight FISH
Tissue Implementation Kit)
*The use of the genetic analyser’s brand name/kit refers to a specific analytical method and the corresponding experimental protocol
Site of assessment: Permanent laboratory premises, 52 Spaton Avenue, 15344, Gerakas, Attiki, Greece.
Approved signatories: G. Nasioulas, A. Apessos, V. Mariatou-Metaxa, I. Papadopoulou, Κ. Agiannitopoulos,
T. Bourkoula, G.Pepe, C.Efstathiadou, G. Tounta.
This scope of Accreditation replaces the previous one dated 21.07.2016.
The Accreditation Certificate No. 822-5, to ELOT EN ISO 15189:2012, is valid until 24.06.2020.
Athens, April 06, 2017
Ioannis Sitaras
Director of the Laboratories Accreditation Division
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Annex G1/9 to the Certificate ESYD No. 822-5
06.04.2017