Advice

The technology

The technology

ProciseDx (BHR Pharmaceuticals) is a point-of-care instrument for inflammatory bowel disease (IBD). This briefing focuses on the use of the platform for monitoring levels of inflammation and measuring levels of the therapeutic drugs infliximab and adalimumab.

The ProciseDx system includes 2 assays for monitoring inflammation: Procise CRP (C‑reactive protein) and Procise FCP (faecal calprotectin). C-reactive protein is a marker of inflammation in the body, which increases with active disease. Faecal calprotectin is also a biomarker which can be used to support a new diagnosis of IBD and to predict and assess possible relapse in people already diagnosed. Procise CRP can be done using finger-prick whole blood, venous blood or serum samples, while Procise FCP uses a stool sample collected with the Procise stool collection device.

ProciseDx also includes 2 assays for measuring levels of therapeutic drugs: Procise IFX (infliximab) and Procise ADL (adalimumab). Infliximab and adalimumab are biological drugs which target proteins and enzymes in the body that cause inflammation. Measurement of infliximab or adalimumab concentrations in the blood may help healthcare professionals to optimise dosing and manage IBD. Procise IFX and Procise ADL can be done with finger-prick whole blood, venous blood or serum samples. Procise IFX has been validated for use with Remicade, Remsima, Inflectra, Flixabi and Rensflexis, while Procise ADL has been validated for use with Humira, Amgevita and Imraldi. Both assays have been calibrated against respective World Health Organisation international standards.

All assays run on the ProciseDx analyser. This is a fully automated instrument that uses time-resolved fluorescence resonance energy transfer signal to detect the presence and quantity of the target analyte. The company claims the technology returns lab-quality, quantitative results in 2 to 5 minutes. This can help healthcare professionals to make immediate treatment decisions.

Innovations

The company claims ProciseDx is easy to use and is small enough to place near the person who is being treated. It can be used with several specimen types, including finger-prick whole blood. Finger-prick whole blood sampling is quicker than serum sampling that is used in other point-of-care tests for IBD. ProciseDx uses lumiphore technology which reportedly allows for brighter and longer time-resolved fluorescence resonance energy transfer. The company claims this results in better sensitivity.

Current care pathway

IBD describes long-term conditions that cause inflammation of the gut. The 2 main forms of IBD are ulcerative colitis and Crohn's disease. Ulcerative colitis affects the large intestine, while Crohn's disease can affect any part of the digestive system.

People with suspected IBD are referred for specialist assessment with a consultant gastroenterologist. IBD is diagnosed using clinical evaluation and a combination of haematological, endoscopic, histological and imaging-based investigations. This may include tests to measure inflammation, such as C‑reactive protein and faecal calprotectin. These tests may be laboratory‑based, rapid tests or point-of-care tests.

Treatment for IBD aims to induce remission by healing inflammation and reducing symptoms, or to maintain remission by preventing flare-ups of IBD in the future. There are several drugs that can be used to treat IBD. Infliximab and adalimumab can be used to treat moderate to severe active ulcerative colitis and severe active Crohn's disease in people who have not benefited from conventional therapy. Infliximab or adalimumab is given initially with a loading dose to induce clinical remission in moderate to severe IBD. People whose IBD responds to induction treatment may continue to take these drugs as maintenance.

People having drug treatment are monitored to determine their response to the drug and any adverse effects. People taking infliximab or adalimumab for maintenance therapy should be assessed at least once a year to determine whether ongoing treatment is needed. Therapeutic drug monitoring may identify people who lose response to drug treatment over time and need a higher dose. It may also be used to identify people who are responding well to treatment. Healthcare professionals can use this information to support treatment decisions and dosing.

Therapeutic drug monitoring of infliximab and adalimumab may be done using enzyme‑linked immunosorbent assay (ELISA) kits or point-of-care tests. NICE's diagnostics guidance on therapeutic monitoring of TNF-alpha inhibitors for Crohn's disease advises that ELISA kits show promise for therapeutic monitoring. But there was not enough evidence to recommend routine adoption in the NHS.

Surgery may be needed in people with IBD who have severe symptoms that do not improve with drug treatment.

The following publications have been identified as relevant to this care pathway:

Population, setting and intended user

ProciseDx is a point-of-care platform for IBD. Ulcerative colitis is the most common type of IBD. About 1 in every 420 people in the UK have the condition, while around 1 in every 690 people have Crohn's disease. ProciseDx can be used to assist the diagnosis of IBD and to monitor remission and therapeutic drug levels in people with an existing diagnosis. It is an alternative to other point-of-care and laboratory tests that measure:

  • C‑reactive protein or faecal calprotectin

  • trough or intermediate levels of infliximab or adalimumab.

ProciseDx can be used by healthcare professionals in gastroenterology services in secondary care and outpatient settings, such as rapid access clinics. The tests can be done by healthcare professionals such as IBD nurses, with basic instructions.

Costs

Technology costs

The ProciseDx analyser costs £7,500 per unit (excluding VAT). This includes the ProciseDx calibration cartridge. Costs of the assays and additional accessories are:

  • Procise CRP assay: £100 for 20 tests (£5 per test)

  • Procise FCP assay with Procise stool collection device: £440 for 20 tests (£22 per test)

  • Procise IFX assay: £950 for 20 tests (£47.50 per test)

  • Procise ADL assay: £950 for 20 tests (£47.50 per test)

  • additional Procise stool collection device: £7.50

  • additional ProciseDx calibration cartridge: £145.

The company said assay costs may be lower depending on the number of assays used in an organisation each year. Training on how to use the ProciseDx platform is included in the costs.

Costs of standard care

ProciseDx is an alternative to other point-of-care or laboratory tests for measuring inflammation or therapeutic drug levels in IBD. Costs of comparator tests (excluding VAT) may include:

One expert who commented on this briefing advised that costs for monitoring infliximab and adalimumab levels were approximately £35 per test.

The company claims ProciseDx point-of-care platform may reduce the need for follow-up appointments for results. It may also be used in therapeutic drug monitoring of infliximab and adalimumab, which may impact dosing decisions. Costs associated with appointments and therapeutic drugs include:

  • consultant led gastroenterology outpatient follow up: £148

  • infliximab: £420 per 100 milligram vial

  • adalimumab: £352 per 40 milligram prefilled syringe.

Costs have been taken from the NHS drug tariff (March 2022), NHS England's 2019/20 National Cost Collection data and NICE guidelines and advice.

Resource consequences

ProciseDx is being validated or trialled within 6 NHS trusts. The company claims ProciseDx returns quicker results than other point-of-care or laboratory tests for measuring inflammation in IBD. This may facilitate faster diagnosis and earlier treatment. The company claims ProciseDx can also detect flares in IBD sooner than other tests, with results returned in 5 minutes or less. This may allow healthcare professionals to make treatment decisions during the appointment instead of awaiting test results later. The company claims this could reduce appointments. There is no evidence to support these claims.

ProciseDx may also facilitate faster measurement of levels of biologicals compared with other tests, which can often take 2 to 3 weeks for results to return. For some people, this may result in more accurate therapeutic drug monitoring and more timely clinical decision making. But many people may also need additional tests to measure antidrug antibodies against infliximab or adalimumab. Proactive therapeutic drug monitoring in IBD may be associated with better clinical outcomes (Papamichael and Cheifetz 2019) and cost savings (Martelli et al. 2016) compared with standard care.

ProciseDx can be used by healthcare professionals with minimal training. The tests do not need to be done by trained laboratory technicians.