Summary

Summary

  • The technology described in this briefing is Fungitell, which measures serum levels of (1–3)‑beta‑D-Glucan (BDG), a marker of fungal infection.

  • The innovative aspects are that the Fungitell test is designed to determine the presence of several different fungal pathogens within 1 hour, which is much faster than current culture-based methods.

  • The intended place in therapy would be in secondary care, as an addition to standard care, where suspected fungal infections are treated empirically (that is, based on signs and symptoms). Fungitell may guide antifungal treatment to be stopped sooner in patients who test negative.

  • The main points from the evidence summarised in this briefing are from 5 non-UK studies (1 prospective cohort study, 2 retrospective cohort studies, 1 randomised parallel pilot study and 1 systematic review with a meta-analysis) including a total of 4,708 patients. They show that Fungitell has the potential to safely rule out invasive fungal disease, avoid unnecessary prescriptions and to stop antifungal treatment.

  • Key uncertainties around the evidence are that none of the studies reported useful comparisons against a standard-care approach to antifungal treatment decisions. None were based in the UK and so results may not be generalisable to current NHS practice.

  • The cost of Fungitell is £737.05 per test kit (excluding VAT), which can run up to 42 patient samples in duplicate, plus the cost of additional lab-based consumables and equipment. The cost per patient therefore depends on the number of samples in each run. The overall resource impact may be similar to, or less than, standard care. This would only happen if the additional test costs were offset by a reduction in the costs of unnecessary antifungal treatments and associated adverse effects. One UK-based single-centre study abstract has confirmed the potential for cost savings in an adult intensive care unit.