How IO Biomarker Tests Get Adopted in the NHS: The Genomic Medicine Service Explained

How IO Biomarker Tests Get Adopted in the NHS: The Genomic Medicine Service Explained

For a company launching an immuno-oncology drug that needs a test, getting a UK marketing authorisation is only half the job. In England, patients only get the drug if the test is available, funded and ordered on the right pathway, and the route depends on what kind of test it is. A genomic test goes through the NHS Genomic Medicine Service and the National Genomic Test Directory. A protein test such as PD-L1 immunohistochemistry usually goes through local pathology. NICE, the MHRA and the devolved nations each add their own layer.

This guide is for diagnostics companies, pharma market access teams and companion diagnostic (CDx) leads targeting the UK. It explains how the NHS Genomic Medicine Service is structured, how a new oncology biomarker test gets into the directory, where NICE and the MHRA fit in, and what a sponsor should do, and when. These processes change often, so every section notes how current the sources are. Sources were checked in October 2026.

Key takeaways

• The NHS Genomic Medicine Service (GMS) delivers genomic testing in England through seven Genomic Laboratory Hubs (GLHs), working alongside seven regional Genomic Medicine Service Alliances. Genomics England runs whole genome sequencing analysis and the national genomic data platform in partnership with NHS England.
• The National Genomic Test Directory sets out which genomic tests the NHS in England commissions, for which clinical indications, and who can order them. It is updated each year through an evidence-based evaluation process overseen by NHS England.
• A genomic test needed to identify patients for a drug recommended through a NICE technology appraisal is added to the directory without a separate application, under the joint NHS England and NICE genomic testing pathway.
• Non-genomic biomarkers such as PD-L1 immunohistochemistry are not on the genomic directory. They are usually run by local NHS histopathology laboratories, and NICE takes testing into account when it appraises the drug.
• IVD regulation in Great Britain is in transition. CE-marked IVDs can currently be placed on the GB market until 30 June 2030 at the latest, and draft pre-market regulations published in May 2026 would introduce risk-based IVD classes. Their final form and start date are not yet confirmed.

How the NHS Genomic Medicine Service is structured

NHS England launched the NHS Genomic Medicine Service in October 2018 to give the NHS in England one nationally commissioned model for genomic testing. It has four main parts.

The seven GLHs are Central and South, East, North West, North Thames, South East, South West, and North East and Yorkshire. Each is led by an NHS trust. For a diagnostics company, this matters commercially. Being on the directory does not mean that a specific product will be used. The directory names the test (for example, a gene panel or a single-gene test for a set indication) and the hubs decide how to deliver it.

The National Genomic Test Directory

The National Genomic Test Directory lists every genomic test the NHS in England commissions. For each one it gives the clinical indication, the eligibility criteria, the test technology and which specialties may order it. NHS England guidance says tests should only be requested where a result is highly likely to change clinical management. There are separate cancer and rare and inherited disease directories. The cancer directory is published as spreadsheets covering solid tumours, haematological cancers and CNS tumours.

The directory is updated annually, and new editions are normally published in April. The 2026/27 edition was published in April 2026, and NHS England has issued smaller version updates since then. Always check the live version before you plan anything.

How the annual evaluation process works

NHS England’s published process for updating the directory runs in four broad stages:

1. Application. You propose a new clinical indication, or an amendment to an existing one, on the test evaluation application forms. Applications are accepted all year, but anything that arrives after the published cut-off date is held for the following cycle.
2. Evaluation. NHS England and its test evaluation working groups review the application. There are separate groups for cancer, rare and inherited disease, and pharmacogenomics, and they report to the Genomics Clinical Reference Group.
3. Impact assessment. The Genomic Laboratory Hubs assess capacity, technology, turnaround and cost.
4. Assurance and publication. The change goes through governance approval and is published in the next edition of the directory.

Applications describe a clinical need, not a commercial product. NHS England’s process documents say proprietary technologies are not evaluated through the directory update process. A proprietary test only appears in the directory after NICE has assessed and recommended it. For diagnostics companies, this has a practical consequence. On the directory route you are arguing for an indication and a type of test, then selling to the hubs. If the claim depends on your specific product, the route is through NICE.

How a test needed for a new IO drug gets into the directory

For pharma, the most important rule concerns tests linked to medicines. NHS England does not require a directory application when a genomic test is part of the access criteria for a drug recommended through a NICE technology appraisal. The test is added as a mandated update. NICE technology appraisal recommendations carry a statutory funding requirement for the medicine, and NHS England has committed to making the necessary genomic testing available so that patients can get it.

The joint NHS England and NICE genomic testing pathway sets out how this works in practice:

• NHS England and NICE share horizon-scanning information on genomic topics every quarter, and engage early to agree which tests should be appraised and by whom.
• NICE concentrates on tests likely to have a significant impact on NHS resources, pathways and services. NHS England evaluates all genomic tests before deciding on national commissioning.
• Any test recommended through either route and delivered by the GMS must still go through the directory impact assessment.

The lesson for launch teams is timing. If a drug needs a genomic biomarker that is not already on the directory, raise it at NICE topic selection, not after the marketing authorisation. If the biomarker is already on a directory panel, for example a gene already covered by a solid tumour panel, the question becomes whether the eligibility criteria and turnaround time fit your indication and line of therapy.

Non-genomic biomarkers: PD-L1 and other IHC tests

Most of the biomarkers that matter in immuno-oncology are not genomic. PD-L1 expression by immunohistochemistry is the clearest example, and our guide to PD-L1 as a predictive biomarker explains why its scoring systems and assay differences make it hard to implement. IHC tests are not part of the National Genomic Test Directory. They are usually run by local NHS histopathology laboratories as part of the diagnostic pathway, funded through those trusts’ pathology services, not commissioned nationally through the GMS.

That has three consequences:

• NICE is the main lever. In immunotherapy appraisals, NICE committees have considered whether PD-L1 testing is available in NHS histopathology laboratories and can be put in place. The availability, cost and accuracy of the test are part of the evidence the company has to address.
• Adoption depends on the laboratory. Each lab chooses its own antibody clone, staining platform and validation approach. A drug label tied to a specific assay and scoring algorithm can create a training and implementation burden in many laboratories, and nobody in the NHS has to fund that burden.
• External quality assessment matters. Without national commissioning, consistency comes from accreditation, EQA schemes and professional guidance, not from a central directory.

Tests for other markers, such as tumour mutational burden, MSI or mismatch repair status, can sit on either side of this line depending on the technology used. Mismatch repair IHC is a pathology test. MSI or TMB by sequencing comes under the genomic directory. Check which route applies to the exact method in the label.

NICE’s role: technology appraisals and HealthTech guidance

Technology appraisals with a companion test

When a medicine is used with a test, NICE assesses the test inside the drug’s technology appraisal. The company’s economic model should reflect the cost of identifying eligible patients, and committees consider whether the test is already established in NHS practice. Published reviews of NICE oncology appraisals show that the way CDx costs and test accuracy are modelled can change the cost-effectiveness result. Treat the test as part of the value case, not a footnote.

Standalone diagnostics: the HealthTech programme

NICE no longer runs a separate Diagnostics Assessment Programme. It has merged diagnostics, medical technologies and interventional procedures into a single HealthTech programme, with its own manual (PMG48, most recently updated in October 2025). The early value assessment route was renamed early use assessment, and it can recommend promising technologies for use while more evidence is collected. NICE now expects multi-technology assessments to be the norm when several products do the same job. For a test developer whose product is not tied to one drug, this is the route that can put a named proprietary test into NHS guidance, and so into the directory if it is a genomic test.

MHRA regulation of IVDs: where things stand

IVD regulation in the UK is in transition, and Great Britain and Northern Ireland are on different rules.

For CDx teams, the practical conclusion is that today’s GB CDx route is light, but it will not stay that way. Plan for a CDx being a higher-risk class with approved body involvement under the new regime, as it is under the EU IVDR, which our IVDR companion diagnostics guide covers. If you are co-developing with the US in mind, compare this with the FDA companion diagnostic approval process. The proposed international reliance route could make an FDA approval directly useful in Great Britain.

A practical checklist for an IO launch in England

1. Classify the test early. Is it genomic (directory route) or non-genomic (local pathology route)? Is the claim tied to a specific proprietary assay?
2. Check the live directory. If the biomarker is already covered, check the eligibility criteria, ordering specialties and expected turnaround against your indication and line of therapy.
3. Engage at NICE topic selection. Flag the testing need so NHS England and NICE can agree how the test will be assessed under the joint pathway.
4. Build testing into the appraisal submission. Model test cost, accuracy and positivity rate, and show the test can be delivered with NHS laboratory capacity.
5. Talk to the Genomic Laboratory Hubs and pathology networks. For genomic tests, the hubs decide on platforms and turnaround. For IHC, laboratories need training, scoring guidance and EQA support well before launch.
6. Secure the regulatory status of the assay. Confirm the CE or UKCA position and MHRA registration, and plan for the transition to the new GB pre-market rules.
7. Plan the devolved nations separately. See below.

A note on Scotland, Wales and Northern Ireland

Health is devolved, and the National Genomic Test Directory covers England only. Scotland has its own genomic test directories, maintained by the Scottish Strategic Network for Genomic Medicine, and the Scottish Medicines Consortium appraises medicines. In Wales, the All Wales Medical Genomics Service, part of Genomics Partnership Wales, is commissioned to provide testing that is equitable with the clinical indications in the England directory, and NICE technology appraisals apply. Northern Ireland’s Department of Health reviews and endorses NICE technology appraisals locally, and Northern Ireland follows the EU IVDR for devices. A UK launch plan needs a test access plan for each nation.

Discuss UK test adoption with the people who run it

Getting a test adopted in the NHS is a question that sits between pharma, diagnostics companies, laboratories and regulators, and that mix is what Stream 2: Biomarkers & Companion Diagnostics at ImmunoMark Summit London is built around. On 3–4 March 2027, 400+ senior pharma, biotech and diagnostics leaders are expected in London for keynotes, panels, case studies, pre-arranged 1:1 meetings and a Day 1 drinks reception.

The Stream 2 agenda includes “Regulation of Companion Diagnostics from a Pharma Perspective”, “Companion Diagnostics Commercialisation & Reimbursement Strategy” and “Panel: Global CDx Approval Pathways – EMA, FDA & MHRA Perspectives”. These are the questions this article raises. For more on the event’s CDx focus, see our page on the companion diagnostics conference in London. To see how it fits into the wider calendar, see our overview of pharma conferences in London.

Register for ImmunoMark London 2027

If your company wants to meet this audience, whether you supply CDx assays, IHC and NGS platforms, laboratory services or market access expertise, see the London 2027 sponsorship opportunities.

FAQs

What is the NHS Genomic Medicine Service?

The NHS Genomic Medicine Service is NHS England’s nationally commissioned model for genomic testing, launched in October 2018. Testing is delivered by seven Genomic Laboratory Hubs, supported by seven regional Genomic Medicine Service Alliances, with Genomics England supporting whole genome sequencing analysis and the national genomic data platform. The tests it provides are set out in the National Genomic Test Directory.

How does a new cancer biomarker test get into the National Genomic Test Directory?

There are two routes. A test needed to identify patients for a medicine recommended through a NICE technology appraisal is added as a mandated update, without a separate application. Other changes go through NHS England’s annual evaluation process: an application to propose a new clinical indication or amend an existing one, review by a test evaluation working group, an impact assessment with the Genomic Laboratory Hubs, then governance approval and publication. Proprietary tests are only included after NICE has assessed and recommended them.

Is PD-L1 testing commissioned through the Genomic Medicine Service?

No. PD-L1 immunohistochemistry is not a genomic test and is not in the National Genomic Test Directory. It is usually run by local NHS histopathology laboratories, and NICE considers the availability and cost of testing when it appraises the immunotherapy that needs it.

Does a companion diagnostic need UKCA marking to be used in Great Britain?

Not necessarily at present. CE-marked IVDs can be placed on the Great Britain market until 30 June 2030 at the latest, and all IVDs must be registered with the MHRA. Draft pre-market regulations published in May 2026 would introduce risk-based IVD classes and an international reliance route. Their final form and start date, and whether CE recognition will be extended indefinitely, were not confirmed at the time of writing.

Do the same rules apply in Scotland, Wales and Northern Ireland?

No. The National Genomic Test Directory covers England. Scotland has its own genomic test directories and the Scottish Medicines Consortium. Wales provides genomic testing through the All Wales Medical Genomics Service and applies NICE technology appraisals. Northern Ireland endorses NICE technology appraisals locally and follows the EU IVDR for devices.