UK’s NICE Wants More Research on Tests to Help Identify Sepsis Causes

The UK’s healthcare costs regulator is recommending further research on three new tests that speed up the identification of bacteria and fungi in people with suspected bloodstream infections.

In final guidance released last week, National Institute for Health and Care Excellence says that although the tests show promise, there is not enough evidence to recommend their routine adoption in the NHS.

The guidance addresses Roche Diagnostics’ LightCycler SeptiFast Test MGRADE, Molzym Molecular Diagnostics’ SepsiTest and Abbott Laboratories’ IRIDICA BAC BSI assay. The tests aim to identify the causes of infection more quickly than traditional microbiology techniques, which require blood samples to be incubated and cultured before pathogens can be identified.

The independent Diagnostics Advisory Committee determined that the tests may offer clinical benefit by providing results faster, but there was currently too much uncertainty in their accuracy for clinicians to use them to make treatment decisions, says Carole Longson, NICE’s Health Technology Evaluation Centre director.

Abbott spokeswoman Rachael Jarnagin says IRIDICA is a significant diagnostic innovation compared with the current standard of care in identifying infection-causing pathogens, and the company is focused on generating clinical and health economic data to show the impacts of the platform through various clinical studies over the next several years.

“These studies will aim to demonstrate how IRIDICA may offer a better and faster way to detect and identify the broad range of the pathogens that can cause serious infections — including sepsis — and help clinicians in diagnosing and improving outcomes in the critically ill,” she tells IDDM.

Molzym agrees with NICE that further studies are necessary under coordinated, strictly defined comparators to show the benefits of rapid molecular tests as regards clinical performance and cost effectiveness, says company spokesman Michael Lorenz.

Rapid molecular tests like Molzym’s SepsiTest are used in clinical microbiology laboratories already, although they are operated as an ultima ratio option when cultures stay negative with patients under strong suspect of an infection, he tells IDDM.

“We regard the assessment of NICE a sound compilation and analysis of the current state of results obtained in clinical studies so far,” Lorenz adds.

Roche could not be reached for comment by press time. Read the guidance here: www.fdanews.com/02-16-NICEGuidance.pdf. — Jonathon Shacat