Two new non-invasive diagnostic technologies can be used in the NHS to speed up the diagnosis of endometriosis.
Endometriosis affects around one in ten women of reproductive age in the UK, yet the average time to diagnosis is more than nine years.
NICE’s draft early use healthtech guidance recommends two technologies, Endosure and Endotest, that can be used in the NHS during a three-year period while additional evidence is collected on how well they work. The tests can be used to diagnose endometriosis in primary care, where current diagnostic accuracy can be limited by the availability of other tests and variation in expertise.
Endotest analyses a saliva sample for tiny biological markers called microRNAs, which can indicate whether endometriosis is likely present, with results sent to the treating clinician. EndoSure detects endometriosis by measuring electrical signals in the gut using sensor pads on the abdomen, after the patient fasts and drinks water during the 45-minute test.
A third technology, DotEndo, requires more research before NICE can recommend the NHS to fund early use of it.
In a survey of over 10,000 women conducted by the All-Party Parliamentary Group on endometriosis, over half reported visiting their GP more than ten times before receiving a diagnosis. In the same APPG survey, over half of respondents reported attending an emergency department because of their symptoms.
Delays result from late initial presentation, variation in the expertise of traditional diagnostic transvaginal ultrasound in primary care, delays in referral pathways, and long waiting times for gynaecology services. People with endometriosis have described diagnostic delays as contributing to increased suffering, prolonged ill health, and disease progression that can be more challenging to treat.
The new technologies offer a less invasive, faster approach to receiving a diagnosis that does not rely on ultrasound operator expertise, potentially enabling earlier decision-making and reducing the need for unnecessary invasive investigations.
Currently the only way to definitively confirm an endometriosis diagnosis is by using a diagnostic laparoscopy, but it is invasive, costly, and carries surgical risks. This surgical procedure is carried out under general anaesthetic, where a surgeon inserts a small camera through a tiny cut in the abdomen to look directly inside the pelvis for signs of endometriosis.
Dr Gail Busby, consultant gynaecologist at Manchester University NHS Foundation Trust, said: “As a gynaecologist working with both adults and adolescents, I’ve seen first-hand how endometriosis can devastate young people’s lives, causing them to miss school, struggle through GCSEs and miss out on the experiences that matter most during those formative years. Too many of my patients have spent years being told their pain is normal when it isn’t. These tests are a game-changer because they give us answers much earlier, without the need for invasive surgery, and that means we can start the right treatment sooner. An earlier diagnosis doesn’t just change one person’s life, it frees up appointments and surgical slots for everyone waiting for care.”
Endotest works by analysing a saliva sample to look for biological markers associated with endometriosis. The sample is collected and sent to a laboratory for analysis. The laboratory examines specific molecules called microRNAs, which are tiny biological signals that can indicate whether endometriosis is likely to be present. The result is then returned to the healthcare professional to help inform next steps in diagnosis and care.
EndoSure is a non-invasive test that detects endometriosis by measuring electrical signals in the gut using sensor pads placed on the abdomen. Patients fast for six to eight hours beforehand, and during the 45-minute test are asked to drink water until full, helping the device record gut activity accurately. Results are available as soon as the test is complete.
Both are intended to be used alongside standard clinical practice to support diagnosis, referral and management, and are not standalone diagnostic tests. They should only be used in women where endometriosis is still suspected even though they have a normal clinical examination and either negative or inconclusive imaging results for endometriosis, or no imaging results because imaging is unacceptable or not suitable for them. The tests should only be used by a healthcare professional.
Early economic modelling suggests that both technologies could be cost effective. During the evidence generation period, they will be funded through core NHS funding. Companies are responsible for organising the evidence generation activities, and NICE will review progress annually.
Simran, 15, from Huddersfield, who was treated by Dr Gail Busby said: “Getting my diagnosis honestly felt like the best thing in the world. Everyone kept saying it might be irritable bowel syndrome. I was sent to hospital multiple times and sent back home. When I finally found out what it was, I was so relieved because now I knew what the next step was. The test itself was easy, it wasn’t painful at all. Just drinking water and being monitored. Really simple. And I’m already starting to feel better after my surgery. I know it’s never going to go away completely, but I know I’m not going to be in pain all the time, and that means everything.”
Dr Anastasia Chalkidou, healthtech programme director at NICE, said: “A diagnosis of endometriosis can for some women take the best part of a decade, with the UK average standing at 9 years and 4 months, and rising to 11 years for those from ethnically diverse communities. That delay means living with chronic pelvic pain that affects daily life, relationships and work. These technologies have the potential to change that by giving primary care professionals better non-invasive tools to identify endometriosis earlier allowing earlier and better treatment. Our draft guidance reflects our commitment to getting promising innovations to patients quickly, while making sure the evidence to support their wider use is built in a rigorous way.”
Emma Cox, CEO of Endometriosis UK, said: “For too long, those with endometriosis have faced unacceptable delays in accessing a diagnosis, especially if from ethnically diverse communities, and diagnosis times have been going up, not down, in the last decade. Endometriosis UK welcomes NICE’s announcement that two new non-invasive diagnostic technologies can now be used in the NHS to speed up diagnosis in primary care, whilst further evidence of their accuracy is collected. Speeding up diagnosis times is much needed and would be a major step forward in reducing disease impact and supporting those with endometriosis to live well with the disease. Availability of these new tests needs to go hand in hand with education of GPs and Practice Nurses to ensure prompt access to those that need them, and an end to pain and symptoms not being recognised. This is the perfect opportunity to support Primary Care colleagues with improved understanding of endometriosis, adenomyosis and menstrual health conditions and their symptoms.”