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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) Page 1of 3 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 Page 2of 3 of 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 Page 3of 3 Annex G1/9 to the Certificate ESYD No. 822-5 06.04.2017