Dear Colleague,

We are writing to you regarding the implementation of circulating tumour DNA (ctDNA) testing in the NHS and the requirement for NHS Trusts to procure and fund blood collection kits locally to enable the ctDNA testing.

ctDNA testing is commissioned on the National Genomic Test Directory for:

• patients with suspected non-small cell lung cancer (NSCLC)
• ESR1 genomic testing for breast cancer following National Institute for Health and Care Excellence (NICE) guidance on the use of elacestrant in the treatment of breast cancer.

Prior to routine commissioning, blood collection kits were centrally procured and distributed by ctDNA providers to individual Trusts. This arrangement has now ended and individual Trusts are responsible for procuring and funding blood collection kits locally, in line with other genomic tests, via their own procurement and ordering processes. Current referrers of ctDNA tests have been written to by the testing laboratories outlining how to procure blood collection kits.

We are writing to request your support in helping your Trust identify appropriate funding mechanisms to enable the continued ordering of blood collection kits. As ctDNA testing is expected to expand in the coming years, it is important to ensure consistent procurement of these kits within your trust.

This letter has been copied to the NHS GMS Alliance Clinical Directors in your region, who can provide a list of Trusts referring patients for both breast cancer and NSCLC testing.

Currently the national annual cost of blood collection kits for ctDNA testing is around £625,000. However evidence from the Healthcare Economics report, which has recently been published, shows that in total ctDNA testing will streamline the cancer diagnostic pathway and create savings of around £11 million in other parts of the healthcare system including through:

• earlier access to targeted treatments and reduced need for repeated invasive procedures
• system-wide cost savings from diagnostic procedures for patients with failed genomic tests
• cost savings from avoided mistreatment and associated consequences
• improved quality of life for patients accessing treatment sooner
• shortens the time to molecular diagnosis and thereby helps to meet cancer waiting time targets

Thank you for your continued support. If you have any queries please contact your local ctDNA service provider or NHS GMS Alliance Clinical Director.

Yours sincerely

Professor Dame Sue Hill, Chief Scientific Officer for England , Senior Responsible Officer for Genomics in the NHS, NHS England.
Dr Rhydian Phillips, Director of Diagnostics and Transport, NHS England.
Professor Peter Johnson, National Clinical Director for Cancer at NHS England.