Urothelial Cancer

Background to testing in Urothelial cancer

This is to let you know of an addition to the molecular testing service for selected patients with advanced Urothelial cancers in the NEY GLH which will go live on Monday 14th July 2025.  In the June 2025 version 13 of the national cancer test directory (see https://www.england.nhs.uk/publication/national-genomic-test-directories), somatic testing for variants in the FGFR2 and FGFR3 genes was added for those patients with urothelial cancer where molecular testing will aid in patient diagnosis or management, as in the table below:

*Note that currently we are unable to test for copy number variants in FGFR2, FGFR3, ERBB2 or MET.

Around 20% of patients with metastatic Urothelial Cancer have FGFR gene alterations (small variants or fusions). The recent availability via Johnson & Johnson of the drug Balversa (Erdafitinib) to target those with FGFR alterations, coupled with approval on the national cancer test directory, means that requesting for this test can now commence.

We will test for small variants and fusions in all of the essential and clinical trials targets in table 1 in a single assay. Please note that we will not test for any copy number variants.

Sample requirements:

What to send

• We request samples with >20% estimated tumour cell percentage: please send one tube (Eppendorf or Universal) containing 5-10 x 10μm FFPE curls.
• For samples with lower overall tumour percentage: if there is a region of the block with >20% tumour, please either; a. macrodissect tumour-rich regions and send in a single tube (preferred), or b. send 10 x 5μm slide mounted sections along with marked H&E with tumour rich area(s) marked.
• If it is not possible to macrodissect out a tumour rich region >20%, please contact the laboratory for further guidance as to whether the sample can still be tested.

Where to send to

Samples should be sent to your local genomics laboratory (see table 2 below) using the GLH solid cancer referral form (Referral Forms – North East and Yorkshire Genomic Medicine Service North East and Yorkshire Genomic Medicine Service). Please ensure that it

• Includes email addresses for your Cell Path secretaries and pathologist. Results will be returned to the pathologist for integration into the full histopathology report and should not be acted upon out of context of those findings;
• Clearly specifies which tests are needed, including M code(s);
• Clearly specifies tumour cell nuclei as a percent of nucleated cells.

Testing and reporting

Sequencing of samples will continue to be undertaken by the GLH in Leeds using the ThermoFisher Scientific Oncomine™ Precision Assay gene panel. Results will be reported by your local genomics laboratory in PDF format to the referring centre histopathology contacts provided. We will aim to issue reports within 14 days of sample receipt.

For any questions about the above changes, please contact the Sheffield cancer genomics team at [email protected].

Limitations of testing

Please note that this testing will not detect ERBB2, MET, FGFR2 or FGFR3 copy number changes.

NEY GLH genomics labs contact details

Yours sincerely

Paul Roberts – Solid Cancer Scientific Lead NEY GLH [email protected]
Gavin Cuthbert – Cancer Lead, Newcastle Genetics Laboratory [email protected]
Rebecca Pollitt – Cancer Lead, Sheffield Genetics Laboratory [email protected]
Julie Atkey – Cancer Lead, Leeds Central Genetics laboratory [email protected]
Alistair Greystoke – Clinical lead for Cancer – NEY GLH, [email protected]