Ensuring diagnostic technologies are introduced quickly and safely

Having been fully established last year, the programme has since gone on to produce guidance on several products

We produce guidance on innovative medical diagnostic technologies to ensure clinically and cost effective tests are adopted quickly and consistently by the NHS.

Our diagnostics guidance is based on recommendations made by the independent Diagnostics Advisory Committee.

The diagnostics assessed consist of a range of measurements and tests that are used to evaluate a patient’s condition. These include:

  • physiological measurements
  • laboratory tests and pathology tests
  • imaging tests
  • endoscopy

In August 2013, we published guidance on a  test  to detect the spread of breast cancer which could help avoid further surgery.

In current practice, patients having breast cancer surgery to remove the main tumour, often have some of the lymph nodes from their armpit removed at the same time

A histopathology test is then carried out on the removed lymph nodes to determine whether cancer cells have spread from the main breast tumour. It can take up to 15 working days to receive results from this test, which if positive, could lead to a second operation to remove the remaining lymph nodes.

Each year around 11,000 people with breast cancer require this additional operation to manage the spread of the disease.

Our guidance recommended RD-100i OSNA system as a test that can be used during breast cancer surgery to detect the presence of biological markers associated with  the spread of cancer, in the lymph node biopsy.

The guidance says that using this test during surgery can determine whether any lymph nodes that the cancer has spread to should be removed at the same time as the initial tumour.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "For people with breast cancer and their families, waiting to hear if the disease has spread can cause significant distress and anxiety.

"If the test is positive, and a second operation is needed to remove more of the axillary lymph nodes, the second operation can be technically more difficult and result in a higher risk of complications - because it will involve operating on the same area of the breast and armpit as the first operation."

She added: "The Committee heard from a patient expert that the option of not having to have a second operation was an important consideration for patients. The Committee also considered that the accuracy of histopathology may vary depending on the number and size of the lymph node sections examined.

"The Committee therefore concluded that analysis of sentinel lymph nodes using the RD-100i OSNA system during operations had considerable advantages over traditional histopathology testing and had the potential to reduce both clinical complications, and patient anxiety and distress."

New diagnostic tests to help diagnose serious bowel conditions

In October 2013, we published guidance on a simple stool test which can help GPs decide whether patients have irritable bowel syndrome (IBS) or other more serious bowel conditions.

Symptoms associated with irritable bowel syndrome (IBS), and the potentially more serious condition irritable bowel disease (IBD), often overlap. This means that making a correct diagnosis can be difficult, resulting in patients with IBD suffering delays receiving treatment, or those with IBS could receiving unnecessary invasive treatment such as endoscopy.

The guidance on tests for inflammatory bowel disease recommends simple  tests which measure the levels of the protein calprotectin in stools.

If the bowel is inflamed, as in IBD, this can lead to higher than normal levels of the protein passing into the intestine.

Consequently, determining the quantities present can be used to help distinguish between inflammatory bowel diseases and non-inflammatory bowel diseases.

NICE says the tests are not recommended for people who are being considered for referral for suspected cancer, as inflammatory markers are also present in bowel cancer.

Professor Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: "Currently a number of tests are carried out in both hospitals and GPs' surgeries to rule out conditions rather than to diagnose.

"This means people often face uncertainty, lots of visits to hospitals and their GP and repeated tests - some of them invasive and uncomfortable. Many people with IBD, particularly children with Crohn's disease, sometimes have to wait for several years for their condition to be diagnosed.

"Looking at the available evidence, we found that faecal calprotectin testing is a good way to distinguish between IBD and IBS."

She added: "As well as being of benefit to patients, the tests will also save the NHS money. They will reduce both the time spent searching for a diagnosis and the numbers of invasive procedures such as colonoscopy.

"The test is also likely to reduce the demands on colonoscopy departments which will be able to focus on people being investigated for more serious conditions such as bowel cancer."