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NICE Grants Draft Approval to Two Endometriosis Diagnostic Tests for NHS Use

Elena MarquezPublished 3w ago5 min readBased on 3 sources
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NICE Grants Draft Approval to Two Endometriosis Diagnostic Tests for NHS Use

NICE has given draft approval to two diagnostic tests for endometriosis, EndoSure and Endotest, clearing them for use in the NHS in England and Wales. The recommendation, published Tuesday, July 7, 2026, covers a three-year evaluation window during which further evidence will be gathered before the health technology assessment body decides whether to recommend the tests permanently Guardian.

The two technologies work on different biological principles. Endotest analyses a saliva sample sent to a laboratory, screening for microRNA signatures associated with endometriosis; published data put its sensitivity above 95% Medscape. EndoSure instead uses sensor pads placed on the abdomen to measure electrogastrographic signals — electrical activity in the gut altered by pelvic adhesions and lesions — with a result in 45 minutes Guardian. A third candidate, DotEndo, was not recommended; NICE said the evidence base for it needs further development.

Both approved tests are intended for a specific point in the diagnostic pathway rather than as standalone replacements for laparoscopy or imaging. NICE's guidance restricts their use to women in whom endometriosis is still clinically suspected after a normal pelvic exam, and where imaging — typically transvaginal ultrasound or MRI — has returned a negative or inconclusive result, or has not been performed at all. In practice, this positions EndoSure and Endotest as second-line triage tools in primary and secondary care rather than a first port of call.

The clinical rationale rests heavily on the well-documented diagnostic lag for endometriosis. Dr Anastasia Chalkidou, NICE's healthtech programme director, cited an average UK diagnosis time of nine years and four months from symptom onset to confirmed diagnosis Guardian. That interval reflects a mix of factors familiar to anyone working in gynaecology: symptom normalisation, limited specialist capacity, and the fact that definitive diagnosis has conventionally required diagnostic laparoscopy, an invasive surgical procedure with its own waiting-list pressures.

Clinical reaction has been largely favourable. Dr Gail Busby, a consultant gynaecologist at Manchester University NHS Foundation Trust, described the tests as a "gamechanger" Guardian. Endometriosis UK welcomed NICE's move, framing the two technologies as non-invasive tools capable of accelerating diagnosis within NHS pathways NICE.

The three-year conditional window is a familiar NICE mechanism for technologies with promising but not yet mature evidence bases — it allows real-world data collection on diagnostic accuracy, downstream clinical decision-making, and cost-effectiveness before a permanent recommendation is issued or withdrawn. For endometriosis specifically, the stakes of getting this right are unusually high given how much downstream treatment planning, including hormonal therapy and surgical referral, depends on a confirmed diagnosis rather than a presumptive one based on symptoms alone.

What will matter over the next three years is less the sensitivity figures published so far and more how these tests perform when deployed at scale across varied NHS settings, and whether false positive or false negative rates hold up outside trial conditions. Sensitivity above 95% for Endotest is a strong headline number, but health technology assessment bodies have historically distinguished between analytic performance in controlled studies and clinical utility once a test is integrated into referral pathways involving GPs, gynaecologists, and often long imaging queues. NICE's evidence-generation requirement over the next three years is designed precisely to test that gap.

There is also a broader structural question about capacity. A faster path to suspecting or confirming endometriosis does not by itself shorten the queue for the specialist gynaecological services, surgical intervention, or pain management that follow diagnosis. Diagnostic acceleration without matched investment in downstream treatment capacity risks simply moving the bottleneck rather than removing it — a dynamic NICE and NHS commissioners will need to track alongside the diagnostic accuracy data during the evaluation period.