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Hellenic Accreditation System

Annex G1/8 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)

4.Paraffin-embedded 1. Somatic mutation detection in exons 18, 19, 20, In-house method with Ion
tissue, cytology specimens 21 of EGFR gene AmpliSeq™ Panel primers

Page 1of 3 Annex G1/8 to the Certificate ESYD No. 822-5 21.07.2016
Materials/Products tested Types of test/Properties measured Applied methods/Techniques
used

(Thermo Fisher Scientific) and


2. Somatic mutation detection in exons 2, 3, 4 of
Next Generation Sequencing
KRAS and NRAS genes
(NGS) with Ion Proton
3. Somatic mutation detection in exons 11 and 15 of (Thermo Fisher Scientific).
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

5. Paraffin embedded 1. Detection of DNA Microsatellite Instability In-house multiplex fluorescent


tissue, peripheral blood, (MSI) PCR method in five
buccal swab microsatellite loci and
fragment analysis by capillary
electrophoresis with ABI 3130
Genetic Analyser, (Applied
Biosystems)
6. Paraffin embedded 1. Detection and quantification of the ALK gene Chromogenic in situ
tissue rearrangements hybridization (CISH) with
ZytoVision CE-IVD kit,
(ZytoDot SPEC ALK Break
Apart Probe and ZytoDot 2C
CISH Implementation Kit)*
7. Paraffin embedded 1. Detection and quantification of the Chromogenic in situ
tissue overexpression of the HER2/NEU gene hybridization (CISH) with
ZytoVision CE-IVD kit,
(ZytoDot 2C SPEC
ERBB2/CEN 17 Probe KIT)*
8. Paraffin embedded 1. Detection and quantification of the ALK gene Fluorescent in situ
tissue rearrangements hybridization (FISH) with
ZytoVision CE-IVD kit
(ZytoLight SPEC ALK Dual
Color Break Apart Probe and
ZytoLight FISH Tissue
Implementation Kit)
9. Paraffin embedded 1. Detection and quantification of the Fluorescent in situ
tissue overexpression of the HER2/NEU gene 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 refers to a specific analytical method and the corresponding experimental protocol

Page 2of 3 Annex G1/8 to the Certificate ESYD No. 822-5 21.07.2016
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 31.05.2016.


The Accreditation Certificate No. 822-5, to ELOT EN ISO 15189:2012, is valid until 24.06.2020.

Athens, July 21, 2016

Ioannis Sitaras
Director of the Laboratories Accreditation Division

Page 3of 3 Annex G1/8 to the Certificate ESYD No. 822-5 21.07.2016