ProciseDx point-of-care platform for inflammatory bowel disease

The technology described in this briefing is ProciseDx. It is used for monitoring levels of inflammation and therapeutic response to infliximab and adalimumab in inflammatory bowel disease (IBD).

The innovative aspects are that it is a point-of-care platform with 4 different assays for measuring C‑reactive protein, faecal calprotectin, and levels of infliximab and adalimumab. It can be used with several specimen types including finger-prick whole blood, with results in less than 5 minutes.

The intended place in therapy would be as an alternative to C‑reactive protein and faecal calprotectin tests, and tests for therapeutic monitoring of infliximab and adalimumab in people with IBD.

The main points from the evidence summarised in this briefing are from 6 studies (4 prospective validation studies and 2 retrospective observational studies) including a total of 622 adults and 45 specimens. They show that the Procise assays have comparable accuracy to established laboratory tests for IBD and are quicker to return results.

Key uncertainties around the evidence or technology are that all studies were reported in preprints or abstracts. There was no evidence on the prospective use of ProciseDx in clinical care or therapeutic drug monitoring.

Experts advised that ProciseDx would return results quicker than standard care. This could facilitate faster treatment decisions and reduce delays in optimising treatment. But ProciseDx does not measure antidrug antibodies which is a limitation compared with other assays. More evidence is needed validating the Procise assays against standard laboratory tests for IBD.

The cost of the ProciseDx platform is £7,500 for the ProciseDx analyser (which includes the ProciseDx calibration cartridge) and between £5 to £47.50 per assay (excluding VAT). The costs of comparator tests are between £5 and £35 per person.