UKAS ISO 15189

The NewGene laboratory has received UKAS accreditation to ISO 15189 Medical Laboratories for the following tests:

Molecular Pathology

  • BRAF targeted mutation detection (colorectal cancer, hairy cell leukaemia and melanoma)
  • EGFR targeted mutation detection (non-small-cell lung cancer)
  • RAS targeted mutation detection in colorectal tumours including KRAS and NRAS genes

Molecular Haematology

  • BCR-ABL monitoring in chronic myeloid leukaemia
  • cKIT targeted mutation analysis (mastocytosis and acute myeloid leukaemia)
  • JAK2, MPL and calreticulin targeted mutation detection in myeloproliferative neoplasms
  • TPMT genotyping

Molecular Genetics

  • Breast cancer: Full gene sequencing of the BRCA1 and BRCA2 genes
  • Noonan spectrum disorders: Full gene sequencing for the following genes - PTPN11, SPRED1, KRAS, SOS1, RAF1, NRAS, BRAF, SHOC2 (exon 1 only), MAP2K1, MAP2K2, HRAS, CBL , NF1, RIT1 and A2ML1
  • Familial hypercholesterolaemia targeted mutation detection in genes APOB, PCSK9 and LDLR

Cick here to view Newgene’s Schedule of Accreditation

Care Quality Commission


NewGene participates in the following external quality assessment programmes.

UK NEQAS for Molecular Genetics:

  • Next generation sequencing
  • BRCA1 and BRCA2 sequencing
  • KRAS
  • EGFR
  • BRAF
  • GIST (new pilot)

UK NEQAS for Leukocyte Immunophenotyping:

  • JAK2
  • BRAF (Hairy cell)


NewGene participates in both national and international external quality assessment programmes

NewGene Ltd

Bioscience Building, International Centre for Life, Newcastle upon Tyne, NE1 4EP, UK
Tel: +44 (0)191 242 1923 | Fax: +44 (0)191 241 8799 | Email: info@newgene.org.uk | Web:www.newgene.org.uk

NewGene Limited | Company Number: 06735445

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