The UK’s National Institute for Health and Care Excellence (NICE) has recommended two non-invasive endometriosis diagnostic tests for use across Britain’s National Health Service (NHS), as wait times for the condition average more than nine years.
Through a draft early use healthtech guidance, the UK health watchdog has preliminarily greenlit the use of these new diagnostic tools as complementary options alongside standard clinical practice for a three-year period, during which additional evidence will be generated to determine their success.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The first test given the initial NICE go-ahead is EndoSure, which is designed to pick up electrical signals in the gut through abdominal sensor pads over a 45-minute testing period. By identifying unique patterns associated with the release of pro-inflammatory prostaglandins by endometriosis tissue, the test’s maker, EndoSure, says the diagnostic tool can work with 98-99% accuracy. Results are available right after the procedure.
The second NICE-recommended diagnostic, Ziwig Endotest, screens for endometriosis through a next-generation sequencing (NGS) approach, in which a saliva sample is tested for 109 different microRNAs (miRNAs) associated with the condition. The results, which are sent to a laboratory for analysis, take between two and three weeks to come back.
Both diagnostic tools, NICE says, can be used in primary care to identify endometriosis – a condition that impacts 10% of women of reproductive age and is characterised by the growth of uterine tissue outside of its usual location, causing intense pain, inflammation and potential infertility.
Taking steps to improve UK endometriosis diagnosis
The initial inclusion of EndoSure and Ziwig Endotest on the NHS will be a positive step forward for patients seeking diagnosis in the UK, who often have to undergo an invasive keyhole surgery to secure a definitive diagnosis.
While NICE notes that neither test will be used as a standalone diagnostic, the agency says that their introduction will offer a “less invasive, faster approach to receiving a diagnosis that does not rely on ultrasound operator expertise”, which could allow for earlier decision-making and diminish the need for unnecessary invasive procedures.
Their introduction to the NHS comes as many women in the UK struggle to obtain a timely confirmation of their endometriosis, with a survey of more than 10,000 women finding that 50% visited their GP more than 10 times before receiving a diagnosis.
According to Dr Anastasia Chalkidou, healthtech programme director at NICE, the introduction of non-invasive diagnostics could also allow for earlier and better treatment.
Such a test made all the difference for 23-year-old Ami Robertson, who spent years being told her pain was something else entirely, leading her to “doubt myself, wondering if it was all in my head”.
“When I finally had the test, it took less than an hour and gave me something I’d never had before: concrete evidence I could take to my doctor. For the first time, I was believed, and I could finally get the help I needed. Today, my quality of life is night and day compared to before. No one should have to wait years to be believed,” Robertson added.
In a previous interview with Pharmaceutical Technology, sister publication of Medical Device Network, experts noted that non-invasive diagnostics are on the cusp of a turning point, but systemic barriers to implementation – specifically reimbursement and evidence generation – remain ever-present.
