As part of NICE's work on evaluating medical technologies, the Diagnostics Assessment Programme (DAP) focuses on the evaluation of innovative medical diagnostic technologies in order to ensure that the NHS is able to adopt clinically and cost effective technologies rapidly and consistently.

Diagnostics includes all types of measurements and tests that are used to evaluate a patient's condition, such as physiological measurements, laboratory tests and pathology tests, imaging tests, and endoscopy.

Diagnosis is the process of identifying whether the patient has a disease at the time of testing. It is performed for patients with specific complaints or in whom signs or symptoms have been noted that may indicate a disease. Tests can have several different uses in the process of diagnosis, for example:

  • Ruling in or out a specific disease
  • General examination looking for clues to the cause of the symptoms
  • Staging, or additional testing to assess how advanced or severe the disease is
  • Monitoring a patient over time to determine changes in their condition
  • Screening tests to look for conditions in patients without signs or symptoms of the specific condition.

The Diagnostics Assessment Programme (DAP) provides specialist capacity for undertaking complex assessments of diagnostic technologies. In many cases, the meaningful assessment of diagnostic technologies requires detailed knowledge of the post-diagnosis care pathways, which results in considerable complexity.

The programme is closely linked to NICE's Medical Technologies Evaluation Programme MTEP) and the Medical Technologies Advisory Committee (MTAC). MTAC undertakes topic selection for all medical technologies and routes appropriate diagnostics topics to the DAP.

Developing diagnostics guidance

Diagnostics guidance may cover a single diagnostic technology or product, or more than one diagnostic technology or product.

An overview of the development process:

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  1. Assessment topics chosen

    NICE's Medical Technologies Advisory Committee selects topics for assessment by the diagnostics assessment programme.

  2. Stakeholders identified

    National organisations representing patients and carers, and also health professionals involved in their care are registered as stakeholders, and are consulted throughout the assessment process.

  3. Scope prepared

    The scope defines the disease(s), the patients and the technology(ies) covered by the assessment and the questions it aims to answer. NICE registered stakeholders and specialist committee members can all contribute to the development of the scope.

  4. Specialist Committee members recruited

    The Diagnostics Advisory Committee is an independent advisory committee. Specialist members with expert knowledge of the subject are recruited to the Committee for the duration of the assessment.

  5. Information provided by manufacturers

    NICE invites manufacturer(s) of the technology being assessed, to provide relevant published and unpublished information and data to the assessment.

  6. Diagnostics assessment report (DAR) prepared

    NICE commissions an independent academic centre to review the evidence on the technology and prepare the diagnostic assessment report. Registered stakeholders are invited to comment on the report.

  7. Diagnostics Advisory Committee meeting

    An independent advisory committee considers the evaluation report and formulates draft recommendations. The Committee discussions are held in public.

  8. Diagnostic consultation document (DCD) produced

    The advisory committee makes its provisional recommendations in the DCD. Registered stakeholders have 4 weeks to comment on the DCD. The DCD is also made available on our website so health professionals and members of the public can comment on it.

  9. Final guidance produced

    The Committee considers the comments received on the DCD then makes its final recommendations on the technology.

  10. Resolution

    Once NICE’s Guidance Executive formally approves the final guidance, individuals or organisations who commented on the draft guidance are notified. They can request corrections to the guidance due to breach of process or factual errors.

  11. Guidance issued

    If there are no resolution requests, NICE issues its final guidance to the NHS in England.

 

Useful documents

The programme manual describes how the NICE Diagnostics Assessment Programme develops guidance. The programme is designed to ensure that robust guidance is developed for the NHS in an open, transparent and timely way, allowing appropriate input from stakeholders.

The following addenda have been made to the programme manual:

View guidance

Notify a product to NICE

Get involved

Find out more about the Diagnostics Committee, including how to attend a meeting.