Our policy on molecular diagnostics

graphic depicting molecular diagnostics

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The growing field of precision medicine allows cancer patients to be separated into different groups based on analysis of their tumours at a molecular level. The NHS must be ready to make these therapies available to patients once they are licensed and approved, so that people with cancer can benefit quickly.

Thanks to recent scientific advances, we can now develop medicines targeted towards specific patient groups and their cancer type, offering the opportunity to improve response rates and reduce or avoid harmful side effects in patients. This is also sometimes referred to as “stratified”, “personalised”, or “targeted” medicine. It’s estimated that up to 90% of cancer drugs in late stage development are targeted treatments of this kind. Cancer Research UK is leading the way in this field of research through our Stratified Medicine Programme.

The Government has announced its intention to create a National Genomic Medicine Service by 2019, integrating precision medicine into mainstream NHS care. As part of this ambition, the Government must ensure the NHS has the infrastructure and capacity to conduct appropriate molecular diagnostic tests.

Molecular diagnostic tests can detect certain genetic mutations. However, there are challenges in terms of patient access to these tests, and significant variation in availability across the country. For example, we estimated that in 2014 around 24,000 patients in England missed out on molecular diagnostic tests of this kind (see our report Molecular Diagnostic Provision in England, below).

In 2016 NHS England introduced six molecular diagnostics tests for cancer, for use until 2018/19. The Welsh Government launched its National Genomic and Precision Medicine Strategy in July 2017. In Scotland, there are already four well-established centres offering a variety of nationally commissioned tests.

We believe patients should be able to access the most appropriate cancer drugs for them, regardless of where they live. We will continue to work with Government, regulators, and industry to influence the availability of these tests.

Commissioning of genetic molecular diagnostic tests for cancer in England

Within the NHS in England, the commissioning arrangements for genetic testing for cancer has been unclear, which has resulted in poor and varied use of these tests and, ultimately, patients being denied access to appropriate treatment.

This was highlighted in last year's Cancer Strategy for England and, as an initial step, NHS England has brought in new commissioning and funding arrangements for an initial six molecular genetic tests. However, whilst some detail was set out in the 2016/17 National Payment System document, there was a lack of clarity as to how these arrangements should be operating on the ground in the NHS in England.

We have worked with the ABPI, BIVDA and NHS England to develop a factual guide aimed at helping to inform clinicians and pathologists of these new arrangements. 

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