Women in England are set to gain new, taxpayer-funded tests for endometriosis after NICE recommended them for regular use.
The two non-invasive diagnostics are Endosure from Maryland-based medtech EndoSure Inc., and Endotest, created by French biotech Ziwig.
The tests have been available in England through private payments, but the country's drug value watchdog NICE now recommends (PDF) that they can be paid for under the taxpayer funded-NHS system and made available through primary care doctors.
The recommendation comes with a proviso, however, that the tests are to be used for a three-year period while “additional evidence is collected on how well they work,” according to a NICE statement.
The idea is to speed up treatment of a disease that many women have struggled to be formally diagnosed with. Endometriosis affects around 10% of women of reproductive age in the U.K. and can cause pain, fatigue, GI symptoms are more—but the average time to diagnosis is more than nine years.
Currently the only way to confirm an endometriosis diagnosis on the NHS is by using a diagnostic laparoscopy. This is however, according to NICE, “invasive, costly, and carries surgical risks.” The two new tests are set up to be safer, quicker and more accessible options.
Endotest works by analyzing a saliva sample for small biological markers called microRNAs to show whether endometriosis is present.
EndoSure, meanwhile, detects endometriosis by measuring electrical signals in the gut using sensor pads on the abdomen. For this, patients need to fast and drink water during a 45-minute test.
NICE did not, however, recommend a third technology, namely DotLab’s blood test DotEndo. This was because it “requires more research before NICE can recommend the NHS to fund early use of it,” the health technology assessor said in a release.
“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,” said Anastasia Chalkidou, Ph.D., healthtech programme director at NICE, in a statement.
“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.”
This is a draft recommendation and the tests cannot be used on the NHS until a final positive green light has been given.