About diagnostics guidance

Our diagnostics guidance helps people in the NHS make efficient, cost-effective and consistent decisions about adopting new products. It supports innovation, transformation and improves healthcare delivery.

What it covers

Diagnostic technologies may be used for various purposes. These include:

• 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.

How we develop guidance

• Diagnostics Assessment Programme process timeline

• Diagnostics Assessment Programme manual (PDF) (this document only applies to appraisals that started with us before 1 February 2022)

• interim addendum on guidance reviews (PDF)

• interim addendum on access proposals (PDF)

• interim addendum on scoping workshops (PDF).

Get involved

To get involved, you can:

• comment on draft recommendations

• take part in guidance development as a stakeholder

• attend a diagnostics advisory committee meeting.

Types of recommendation NICE can make

Our recommendations are prepared by independent advisory committees comprised of both health professionals and people who are familiar with the issues that can affect patients and carers.

We make 4 types of recommendation which apply across all our guidance products. These allow us to produce clear, directive, actionable guidance that is easy to understand and put into practice.

• View the types of recommendation NICE can make.

Static list

We regularly review our diagnostics guidance. If there is no new research or evidence available that would have a material effect on the guidance, it gets moved to the static list. If new evidence becomes available, the guidance can be transferred back to the active list for further appraisal.

The following guidance has been transferred to the static list.

Ref: DG1

• Title: The EOS 2D/3D imaging system

• Date issued: October 2011

• DG1 Review decision

Ref: DG3

• Title: New generation cardiac CT scanners

• Date issued: January 2012

• DG3 Review decision

Ref: DG5

• Title: SonoVue (sulphur hexafluoride microbubbles)

• Date issued: August 2012

• DG5 Review decision

Ref: DG6

• Title: Depth of anaesthesia monitors - Bispectral Index (BIS), E-Entropy and Narcotrend-Compact M

• Date issued: November 2012

• DG6 Review decision

Ref: DG8

• Title: Intraoperative tests (RD 100i OSNA system and Metasin test) for detecting sentinel lymph node metastases in breast cancer

• Date issued: August 2013

• DG8 Review decision

Ref: DG9

• Title: EGFR‑TK mutation testing in adults with locally advanced or metastatic non-small-cell lung cancer

• Date issued: August 2013

• DG9 Review decision

Ref: DG11

• Title: Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel

• Date issued: October 2013

• DG11 Review decision

Ref: DG12

• Title: Measuring fractional exhaled nitric oxide concentration in asthma: NIOX MINO, NIOX VERO and NObreath

• Date issued: April 2014

• DG12 Review decision

Ref: DG14

• Title: Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system)

• Date issued: September 2014

• DG14 Review decision

Ref: DG16

• Title: Fluorouracil chemotherapy: The My5‑FU assay for guiding dose adjustment

• Date issued: December 2014

• DG16 Review decision

Ref: DG19

• Title: VivaScope 1500 and 3000 imaging systems for detecting skin cancer lesions

• Date issued: November 2015

• DG19 Review decision

Ref: DG20

• Title: SepsiTest assay for rapidly identifying bloodstream bacteria and fungi

• Date issued: February 2016

• DG20 Review decision