In April 2020, NICE announced that Entrectinib and Larotrectinib were made available via the Cancer Drugs Fund for treatment of NTRK fusion-positive solid tumours which meet a set of criteria.

NICE Appraisal Document

Cancer Drugs Fund


Below are details on how this testing is to be provided in the North East and Yorkshire by our Genomics Laboratory Hub.

Patients are eligible for testing as part of phase 1 if their diagnosis is in one of these 5 groups.

1. Four cancers in which NTRK gene fusion incidence is very high (>90%):– Infantile fibrosarcoma– Congenital mesoblastic nephroma– Mammary variant salivary gland cancer– Secretory breast cancer

2. Three cancers in which NTRK gene fusion incidence is between 5 and 25%:– Gastro-intestinal stromal tumours (GISTs)– Thyroid cancers– Spitzoid neoplasms

3. Children (0-16 years) with solid tumours being treated in Principal Treatment Centres

4. Teenagers (16-18 years) with solid tumours

5. Young adults (18-25) with solid tumours

Phase 2 testing, available from October 2020, expands access to a wider patient group.

Solid tumour patients with metastatic/locally-advanced disease, or where surgical resection is likely to result in severe morbidity, for whom standard therapies have failed, or none are available, and are fit for further treatment.

NTRK fusion testing in NE&Y GLH is delivered using the Illumina TruSight 507 gene RNA Fusion panel. This panel will detect any fusion event that involves a gene listed in the panel. The GLH will analyse and report all fusions detected.

For more information please see:

TruSight™ RNA Fusion Panel TruSight™

The sample should be sent to the local genomics laboratory with a completed request form. It is important that the box asking for the patient’s cancer type is appropriately ticked. If this information is not given it may delay testing.

The referring clinician and referring hospital details must also be completed clearly (without use of abbreviations) to ensure the result is reported correctly.

FFPE tissue: 1.5x 10μM FFPE curls with stated tumour contentOR 10x 5μM FFPE sections with labelled H&E (with tumour content of labelled region)slide for macro dissectionFresh tissue: minimum of ~1mm3 tissueFresh frozen tumour tissue on dry ice with locally estimated tumour contentOR Fresh tumour tissue stored in ‘RNA-later buffer’ (Thermofisher) with locally estimatedtumour content.

NB. Do not freeze in ‘RNA-later’ – please store/transport at 4oC

As with other genomic tests undertaken by the GLH, the result will be returned to the referring clinician by either email or uploaded to the electronic patient record as agreed by each referring Trust.

Result enquiries:

RNA Fusion Panel Service,
Newcastle Genetics Laboratory
[email protected]
T. 0191 241 8786