Stockholm3 in NICE Medtech Innovation Briefing for the UK

NICE, the UK National Institute for Health and Care Excellence, has published a Medtech Innovation Briefing (MIB) on Stockholm3, where experts state that Stockholm3 has the potential of improving accuracy in prostate cancer diagnostics. The MIB report is not a recommendation, but generally seen as a first step towards diagnostic guidance in the UK.

NICE has been evaluating Stockholm3 as a means of improving prostate cancer diagnostics in the UK. The outcome of the evaluation is a MIB report providing a thorough external evaluation of Stockholm3, including comments by independent NICE experts and patient organization representatives.

The report highlights that the improved accuracy of Stockholm3 has the potential to reduce unnecessary MRIs and biopsies and that implementation of Stockholm3 could potentially reduce the overall costs of prostate cancer diagnosis in the UK. The clinical evidence is described as “adequate and of good methodological quality”. However, the report mentioned the lack of studies carried out in the UK, and the lack of data on non-Caucasian ethnicities, which are currently in progress.

Several of the experts noted that the use of Stockholm3 could lead to less or similar resource usage compared with current standards of care. A representative from the patient organization Prostate Cancer UK said that ”the benefits of Stockholm3 are that it is convenient and results in quick and accurate care provision” and that “Stockholm3 prevents harm from unnecessary biopsies. For people who are concerned about their prostate cancer risk, this technology could rule out any unnecessary worry of being referred into secondary care for an exploratory MRI scan or biopsy.”

“The MIB report is a great initial step for us in the UK. Even though it is not a diagnostic guidance, it shows that the specific benefits of Stockholm3 are understood and appreciated. We are already conducting studies on non-Caucasian ethnicities, and we are planning to start a validation study in the UK”, says David Rosén, CEO of A3P Biomedical.

While we realize that a diagnostic guidance from NICE will take more time, we can now start contacting private and NHS care providers, based on the findings of this report”, David Rosén concludes.

With more than 52,000 new cases per year, prostate cancer is the most common form of cancer in UK men and one of the deadliest with 12,000 fatalities every year.