Expert comments

Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.

Four experts commented on this briefing. All experts were familiar with or had used tests for monitoring levels of inflammation or measuring levels of the therapeutic drugs infliximab and adalimumab. Two experts were familiar with ProciseDx because it was undergoing testing in their NHS trusts.

Level of innovation

All experts advised that tests of C‑reactive protein, faecal calprotectin, and infliximab and adalimumab levels are routinely used in clinical practice. Two experts said that ProciseDx is a minor variation on an existing procedure. It is innovative because it is a point-of-care test that uses the same analyser for different assays and sample types. Two experts advised that ProciseDx does not measure antidrug antibodies against infliximab or adalimumab. They thought that this was a limitation compared with other assays.

Potential patient impact

All experts described benefits of monitoring levels of inflammation and therapeutic drugs in inflammatory bowel disease (IBD). Tests of C‑reactive protein and faecal calprotectin are important to assess disease activity and monitor clinical outcomes, while therapeutic drug monitoring can help healthcare professionals make therapeutic decisions. Results for C‑reactive protein and faecal calprotectin take at least 24 hours to be returned. Results of therapeutic drug monitoring may not be available for several weeks. All experts commented that ProciseDx could save time in getting results because tests would be done at the point of care instead of in a laboratory. One expert thought people may also prefer finger-prick whole blood sampling to serum sampling.

The experts advised that the technology could have potential harms if the assays are not reliable. This would affect treatment decisions and clinical outcomes. All experts advised that more evidence is needed comparing ProciseDx with standard laboratory tests for IBD.

Potential system impact

The experts commented that ProciseDx could improve the management of IBD by facilitating faster treatment decisions. It may also reduce outpatient appointments because people would not have to return to clinic to get their results. One expert said that faecal calprotectin tests could be used every 3 to 6 months to effectively monitor IBD. People having anti‑TNF (tumour necrosis factor) therapy may also benefit from both reactive and proactive therapeutic drug monitoring once or twice a year. This could help healthcare professionals to detect and manage loss of response earlier, which may reduce flare-ups. The expert believed this could have system benefits because it may reduce the burden on primary care and community resources. It may also reduce emergency visits, hospitalisation, treatment change and surgery.

One expert described ProciseDx as small, portable and easy to use. All experts thought that it could be adopted with no change to standard care processes and only minor training. The experts said that ProciseDx could replace standard tests if objective validation of accuracy was confirmed.

General comments

The experts commented that ProciseDx could be used in most or all district general hospitals if it is shown to be safe and efficacious. One expert advised that it could be used with 80% of people with IBD, specifically people on anti‑TNF drugs or with suspected flares of inflammatory activity. Another expert said point-of-care testing could also be used in hospital settings to assist dosing in acute severe ulcerative colitis, but evidence on this is needed.

All experts advised that more evidence is needed before ProciseDx can be routinely used in the NHS. Research is needed comparing it with standard care tests to strengthen evidence on its reliability and validity in clinical practice. The evidence base would also benefit from research on the impact of point-of-care tests on clinical decision making in IBD, such as dose optimisation and treatment changes.