Regulatory Focus™ > News Articles > NICE Restricts GE's Diagnostic Test to Research Use

NICE Restricts GE's Diagnostic Test to Research Use

Posted 01 August 2012 | By Louise Zornoza

General Electric (GE) Healthcare's diagnostic test (SeHCAT) for bile acid malabsorption in patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and Crohn's disease without ileal resection has been restricted for research use by the National Health Service (NHS) according to draft guidance issued yesterday by the National Institute for Health and Clinical Excellence (NICE). 

The draft recommends restricting SeHCAT to research settings in order to generate further evidence as to its potential benefits. The decision is based in part on the lack of a suitable comparator for NICE to use in a cost-benefit assessment as to GE's test.

Normally, about 95% of bile acids secreted by the liver are recycled back from the small intestine, and malabsorption of the acids is a known cause of chronic diarrhea. The condition is often misdiagnosed as IBS-D, and patients may undergo several investigations, including those for inflammatory bowel disease, colonic cancer, coeliac disease and chronic infections, without a definitive cause being identified. Evidence suggests that as many as half a million patients in the NHS who are currently treated for IBS-D actually have bile acid malabsorption, which is also associated with Crohn's disease, a chronic severe condition characterized by inflammation, ulcers and bleeding that may affect any part of the gastrointestinal tract, including the terminal ileum.

Commenting on SeHCAT, NICE Health Technology Evaluation Centre Director Professor Carole Longson said, "There may well be potential value associated with using SeHCAT, but the relationship of bile acid malabsorption and its treatment to improving patient outcomes is complex and uncertain." 

"The Committee concluded that there is currently not enough evidence to determine whether use of the technology is a useful approach for diagnosing bile acid malabsorption in people with chronic diarrhea who have been diagnosed with IBS-D or Crohn's disease without ileal resection," Longston continued. "But important research is needed to address this evidence gap. This is why we have passed the research needs to the NICE Medical Technologies Evaluation Programme research facilitation team for the development of specific research protocols as appropriate."

Read more:

NICE - SeHCAT (Tauroselcholic [75Selenium] acid) for the investigation of bile acid malabsorption (BAM) and measurement of bile acid pool loss

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