Two tests that can dramatically speed up diagnosis of endometriosis are to be made available on the NHS in England and Wales, in a move hailed as a “gamechanger” for millions of women.
One in 10 women of reproductive age are affected by the condition, where tissue similar to that found in the womb lining grows elsewhere, such as the ovaries and fallopian tubes. Symptoms include painful periods, painful bowel movements, pain when urinating and pain during or after sex.
Current tests include ultrasound scans, MRI or a laparoscopy – where a camera is inserted through a tiny cut in the stomach. But despite the devastating effect it can have on a woman’s physical and mental health, and the large numbers affected, getting a diagnosis can take years.
Women in England and Wales are typically forced to wait as long as a decade. Those eventually diagnosed with endometriosis have said diagnostic delays contribute to increased suffering, prolonged ill health and disease progression that can be more challenging to treat.
Now the National Institute for Health and Care Excellence has given the green light to two tests, EndoSure and Endotest. It says they will help rapidly reduce the time it takes for women to be told whether they have the condition. One provides results in just 45 minutes.
Dr Anastasia Chalkidou, Nice’s healthtech programme director, said: “A diagnosis of endometriosis can for some women take the best part of a decade, with the UK average standing at nine years and four months, and rising to 11 years for those from ethnically diverse communities.”
Delays meant chronic pain, affecting daily life, relationships and work, she said. “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“Our draft guidance reflects our commitment to getting promising innovations to patients quickly, while making sure the evidence to support their wider use is built in a rigorous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.”
With Endotest, women give a saliva sample, which is sent off to a lab to check for tiny biological markers called microRNAs. This indicates the presence of endometriosis. The lab result is returned to the GP or another healthcare professional to inform the next steps in diagnosis and care.
EndoSure can detect the condition by measuring electrical signals in the gut using sensor pads on the abdomen. Women 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.
The draft recommendation, published on Tuesday, approves the tests for three years, during which time further evidence will be collected on how well they work. Nice will then decide whether to grant final approval for permanent use on the NHS.
A third test, DotEndo, needed more research before it could get the green light, Nice said.
The tests were not designed to act as standalone tests but should ensure women were diagnosed much faster, Nice said. They are for women where the condition is still suspected after a normal clinical exam and either negative or inconclusive imaging results, or where imaging has not been used.
Dr Gail Busby, a consultant gynaecologist at Manchester University NHS Foundation Trust, said: “These tests are a gamechanger 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.”
Emma Cox, of Endometriosis UK, also welcomed the tests. They should come with education for GPs and nurses to ensure prompt access and an end to symptoms not being recognised, she said.
