The National Genomic Test Directory
See the latest National Genomic Test Directory
A central feature of the NHS Genomic Medicine Service (GMS) is the National Genomic Test Directory (Test Directory) which outlines the full range of genomic tests that are commissioned for the NHS in England. The Test Directory sets out which genomic tests are available and the patients who are eligible to access a test. To keep pace with scientific and technological advances, while delivering value for money for the NHS a robust and evidence-based process and policy is in place to ensure that genomic testing continues to be available for all patients for whom it would be of clinical benefit.
Updating the National Genomic Test Directory – the process
The Test Directory will be updated annually from 2021 following the structured, evidence-based process described in the NHS England and policy document for Updating the National Genomic Test Directory.
Anyone can apply to update the Test Directory, this may be to consider new test targets, clinical indications, and/or changes to existing tests on the Test Directory. The evaluation of applications to update the Test Directory will include an assessment of the clinical utility, unmet need and benefit to patients evidenced by the data. The process involves clinical and scientific experts, and patient and public voice representatives, ensuring patients are involved in all of our decisions.
Applicants should note that:
- The only circumstances in which the Test Directory may specify a proprietary technology is when this has been assessed and recommended by NICE; in this circumstance the inclusion of the proprietary technology in the Test Directory is to reflect alignment with NICE’s guidance. Applications to consider proprietary technologies will not be evaluated via the NHS England process for updating the Test Directory
Updating the National Genomic Test Directory – application submission and evaluation timelines
Applications can be submitted at any time throughout the year.
- Applications submitted before 31 August 2022 will be reviewed and considered for inclusion in the April 2023 update to the Test Directory
- For applications submitted after 31 August 2022, NHS England will confirm the application review timeline with the applicant. Applications submitted after 31 August 2022 may not be reviewed until the 2023-2024 evaluation period
- Incomplete applications will result in a delay to the review process
- An updated version of the Test Directory will be published in April each year including the changes recommended via the evaluation process.
A summary list of previous applications submitted to update the Test Directory and associated outcomes from the evaluation process are available on request from england.testevaluation@nhs.net.
Application forms and further guidance for applicants are available in the Documentation section below. Please submit completed application forms to the Genomics Unit at england.testevaluation@nhs.net.
NHS GMS gene panel content
NHS England are reviewing the timelines for using the PanelApp process to update NHS GMS gene panel content to align with the annual Test Directory publication. This website will be updated with further information concerning PanelApp review timelines once these have been confirmed.
Fast track process
A fast track process for applications to amend the Test Directory is provided to support amendments that may be identified as requiring implementation more urgently than through the annual update to the Test Directory, for example:
- An error is identified that needs to be corrected to ensure correct delivery of testing
- An urgent change is needed to benefit patients with limited financial impact
- An urgent change is needed to benefit operational implementation in the GMS with limited financial impact
- Newly emerged guidance or clinical policy mandates the amendment
- An urgent change is needed as a result of the COVID-19 response.
Further information on this process and relevant documentation can be found in the documentation section below.
Please submit fast track application forms to the Genomics Unit at england.testevaluation@nhs.net.
Horizon scanning
NHS England undertake ongoing horizon scanning to identify potential future changes to the Test Directory, linked to NICE guidance in development and/or urgent policy statements issued by NHS England.
To support this horizon scanning, stakeholders can notify NHS England of activity which may result in a future change to the Test Directory via the notification form provided.
Please direct any enquires regarding the above information to the Genomics Unit at england.testevaluation@nhs.net