Molecular Pathology reports are fully integrated within APEX and are available electronically via TRAK.  For samples sent from out with NHS Lothian, reports are returned to the requesting clinician and a report is sent to the source pathology department.
 
The Department of Laboratory Medicine adheres to NHS Lothian’s Policy on Confidentiality of Personal Health Information, meaning that results can only be communicated to individuals authorised to receive them.
 
Molecular Pathology reports incorporate histological, morphometric, molecular genetic and cytogenetic information, and will typically include a morphological assessment of the suitability of the specimen, individual test results, a statement on the likely response to therapy (if applicable) and details of the methodology employed.
 
Expected turnaround times for each test, or panel of tests, are as follows:
 
  ​Turnaround (calendar days)​
​Lung Cancer: ​
​        EGFR, KRAS and ALK and ROS1 (IHC only)

14
​        ALK or ROS1 FISH (additional if required) 14
​        EGFR testing of cell-free tumour DNA 7
​        PD-L1 immunohistochemistry 14
​Melanoma: ​
​        BRAF 14
​        NRAS and KIT (additional if required) 14
​Colorectal Cancer: ​
​        KRAS, NRAS and BRAF 14
​        Mismatch repair analysis (IHC and BRAF/MSI as appropriate) 42
​        MMR analysis for histological diagnosis or treatment stratification 7
​Neuropathology: ​
​        MGMT methylation analysis 7
        IDH1 and IDH2
14
​Gastric Cancer: ​
​        HER2 copy number analysis 14
​Gastrointestinal Stromal Tumour (GIST): ​
​        KIT and PDGFRA 14
​Thyroid Cancer: ​
​        BRAF 14
        RAS 14
        TERT 14
Endometrial cancer:  
        POLE 14
        TP53 14
Sarcoma:  

        FISH testing (DDIT3 gene rearrangement, EWSR1 gene rearrangement, FOXO1 gene rearrangement, FUS gene rearrangement, MDM2 gene amplification, SS18 gene rearrangement, USP6 gene rearrangement)

 14
Pharmacogenomics:  
        DPYD genotyping 7
   
 
For guidance on interpretation of Molecular Pathology reports or for any queries please contact a member of the Molecular Pathology team.

Quality Assurance

The Molecular Pathology service carries accreditation to international standard ISO15189:2012. 

All investigations are subject to rigorous Internal Quality Control (IQC) measures and the laboratory participates in the following External Quality Assurance (EQA) schemes:

  • GenQA Colorectal cancer.
  • GenQA Lung cancer.
  • GenQA Additional lung cancer biomarkers.
  • GenQA Melanoma.
  • GenQA Gastrointestinal stromal tumour molecular testing (genotyping only).
  • GenQA CNS Tumours (MGMT and IDH1/IDH2 components).
  • GenQA Sarcoma pilot.
  • GenQA Molecular tissue identification pilot.
  • GenQA Histopathology tissue assessment for molecular testing.
  • UK NEQAS HNPCC Immunohistochemistry.
  • GenQA cfDNA testing in lung cancer pilot.
  • GenQA DNA extraction from blood.
  • GENQA DNA quantification.
  • GENQA NGS for Somatic Testing (pilot).
  • GENQA Pathogenicity of Germline Sequence Variants.

Due to the rapid pace of developments in the field of Molecular Pathology, the department may offer certain services before they have been accredited to ISO 15189.  In all instances, relevant tests will have undergone a period of internal validation/verification and have been deemed suitable for diagnostic use prior to being offered to users.

The current accreditation status of individual tests can be found in relevant sections of our test directory and will always be clearly marked on any reports issued by the service.

Measurement Uncertainty

The impact and estimates of measurement uncertainty are determined for all relevant assays. These are available, on request to users.