NICE backs NHS use of non-invasive endometriosis tests

Women with endometriosis in England could soon be offered simple non-invasive tests for diagnosis of their condition, rather than a diagnostic laparoscopy, a surgical procedure that is costly and carries risk.

The debilitating condition – where tissue similar to the lining of the womb grows elsewhere in the body – affects one in 10 women of reproductive age in the UK, and causes symptoms like pain and extreme tiredness and, if untreated, can result in organ damage and infertility.

Despite being so common, the average time to an endometriosis diagnosis is more than nine years, according to reimbursement agency NICE, which has issued a consultation document (PDF) supporting interim NHS funding of two non-invasive tests – EndoSure and Endotest – while evidence of their clinical usefulness is generated over a three-year period.

EndoSure, developed and sold by a US company of the same name, 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.

Endotest, developed by French healthtech form Ziwig, analyses a saliva sample for a microRNA-based biomarker 'signature' that can be analysed using AI to give an endometriosis diagnosis.

A third technology called DotEndo, another microRNA saliva test developed by US company DotLab, requires more research before it can be recommended for NHS funding, said NICE, which is now seeking feedback on the plans.

Other non-invasive diagnostics are also being trialled for endometriosis, including specialised, tracer-assisted CT scans and menstrual blood tests.

There is no cure for endometriosis, although it can be treated with drugs that provide pain relief, hormonal treatments, and surgery to remove some of the errant tissue, so getting a diagnosis as quickly as possible is crucial.

Last year, NICE recommended a "transformational" new oral treatment – Gedeon Richter's Ryeqo (relugolix/estradiol/norethisterone) – as the first alternative to current injectable GnRH agonist therapies for the condition.

"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," said Emma Cox, chief executive of Endometriosis UK, in a response to the NHS consultation.

"Endometriosis UK welcomes NICE's announcement that two new non-invasive diagnostic technologies," she added. "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."

Cox cautioned, however, that the availability of these new tests needs to go hand in hand with education of GPs and practice nurses to ensure prompt access to them, and "an end to pain and symptoms not being recognised."

In a survey of over 10,000 women conducted by the All-Party Parliamentary Group (APPG) on endometriosis, over half reported visiting their GP more than 10 times before receiving a diagnosis, and a similar proportion said they had attended an emergency department because of their symptoms.

Simran Chavda, a 15-year-old from Huddersfield, began experiencing severe pelvic pain at 13, but repeated GP visits and A&E attendances failed to identify the cause, until she was able to have the EndoSure test.

"Getting my diagnosis honestly felt like the best thing in the world," she said. "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 consultation document on the new diagnostics is open until 27th July.

Photo by Helio E. López Vega on Unsplash