Molecular Pathology

Welcome to the Molecular Pathology department. Our service hours are: 09:00 – 16:30.

Requests, clinical advice and general enquiries can be made by emailing us at:

Services offered by the Laboratory

The molecular Pathology laboratory is a specialised area of the Histopathology department that investigates treatment options for patients post-diagnosis. Currently, the Molecular tests performed by this department focus on lung cancer markers only, these are ALK, EGFR, ROS-1 and PD-L1.


Anaplastic Lymphoma Kinase (ALK) gene translocations are present in <2% of non-small cell carcinomas (NSCLC). Detection of an ALK translocation advocates first line NSCLC treatment with a suitable tyrosine kinase inhibitor (TKI) treatment, for example Crizotinib


Epidermal growth factor receptor (EGFR) is normally associated with cellular proliferation and development. In some NSCLC patients, EGFR mutations contribute to tumour cell proliferation. A collection of activating EGFR mutations have been associated with effective TKI treatment, however, other EGFR mutations have been linked with resistance to first and second generation TKIs. Detection of EGFR mutation status in NSCLC patients is vital for determining the most appropriate treatment regime


Chromosomal rearrangement can lead to kinase fusions in the ROS-1 oncogene causing the active kinase domain to become constitutively active causing NSCLC. ROS-1 rearrangements occur in 1-2% of cases of NSCLC. Detection of a ROS-1 translocation suggests Crizotinib treatment is likely to inhibit ROS-1 kinase activity in ROS-1 positive NSCLC patients.


Programmed death ligand-1 (PD-L1) is a transmembrane protein that is weakly expressed on the cell surface of all healthy cells. Tumours express high levels of cell surface PD-L1 which facilitates evasion of immune cells and allows the tumour cell to proliferate. Analysis of PD-L1 expression in tumour cells can be used to inform first and second line treatment for NSCLC. More information can be found HERE

Specimen Requirements/Instructions for Transportation

Internal Requests:

Requests for Molecular testing must always be discussed at MDT meetings with either Dr Lipsita Patnaik or Dr Danielle Bury

PD-L1, EGFR, ALK and ROS-1 tests require a Formalin Fixed Paraffin Embedded (FFPE) block containing the tumour material to be sent to Blackpool Victoria Hospital so that fresh sections can be cut prior to sample preparation, biopsy and cell block samples are also suitable for testing,

A copy of the original pathology report must be provided with each case.

External Requests:

External requests must be sent with a fully completed request form (see below to download)

Request forms for Molecular testing for users can be downloaded here: External Request Form Template.

Turnaround times

All cases are dealt with as quickly as possible, we aim to have a turn around time of five days from receipt of request, cases are reviewed on a cases by case basis for turnaround times.

Patient Consent

Patients do not need to consent for Molecular testing as the tests are all part of the diagnostic process.

Protection of Personal Information

The laboratory fully complies with GDPR regulations and the protection of personal data and information.


All complaints in the first instance should be directed to either Helen Sanna or Dr Danielle Bury.

Examples of staining:

Below are examples of staining for ROS-1, PD-L1, ALK and EGFR staining.

ROS-1 Staining – A: Strong Positive staining, B: Moderate staining

PD-L1 Positive tumours may express high levels of staining

ALK Staining showing Negative and Positive Staining