Hellenic Accreditation System
Annex G1/6 to the Certificate No. 822-4
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 & Multiplex PCR with BRCA MASTR Dx
BRCA2 genes (Breast Cancer CE-IVD kit (Multiplicom N.V.) and
susceptibility genes 1 and 2)
Next Generation Sequencing (NGS)
with MiSeq (Illumina) *
(Full coding sequence, splice sites
and flanking intronic sequences)
2. Single mutation identification or DNA
sequencing
by
capillary
confirmation in BRCA1 & BRCA2 electrophoresis with ABI 3130 Genetic
genes
Analyser, (Applied Biosystems)*
2. Paraffin-embedded tissue,
cytology specimens
1. Somatic mutation detection in In-house method with TruSeq Custom
exons 18, 19, 20, 21 of EGFR gene Library primers (Illumina) and Next
Generation Sequencing (NGS) with
2. Somatic mutation detection in
MiSeq (Illumina) *
exons 2, 3,4 of KRAS and NRAS
genes
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. Detection of DNA Microsatellite
Instability (MSI)
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In-house multiplex fluorescent PCR
method in five microsatellite loci and
fragment
analysis
by
capillary
electrophoresis with ABI 3130 Genetic
Analyser, (Applied Biosystems)*
Annex G1/6 to the Certificate ESYD No. 822-4
24.11.2015
Materials/Products tested
Types of test/Properties measured
Applied methods/Techniques used
3. Paraffin-embedded tissue
1. Detection and quantification of Chromogenic in situ hybridization
the ALK gene rearrangements
(CISH) with ZytoVision CE-IVD kit,
(ZytoDot SPEC ALK Break Apart
Probe and ZytoDot 2C CISH
Implementation Kit)*
4. Paraffin-embedded tissue
1. Detection and quantification of Chromogenic in situ hybridization
the
overexpression of the (CISH) with ZytoVision CE-IVD kit,
HER2/NEU gene
(ZytoDot 2C SPEC ERBB2/CEN 17
Probe KIT)*
*The use of the genetic analyser’s brand name 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.
This scope of Accreditation replaces the previous one dated 21.07.2015.
The Accreditation Certificate No. 822-4, to ELOT EN ISO 15189:2012, is valid until 24.06.2016.
Athens, November 24, 2015
Ioannis Sitaras
Director of the Laboratories Accreditation Division
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Annex G1/6 to the Certificate ESYD No. 822-4
24.11.2015