Clinical Guidelines and Standards · Guidelines by Clinical Area
RRM Academy Synopsis
NICE draft guidance backs Endotest saliva test for endometriosis
NICE's draft guidance lets the NHS use the Endotest saliva test for endometriosis in primary care. Use follows a normal exam and an ultrasound that is negative, unclear, declined or unsuitable, within a 4-year evidence generation period. The committee wants more research on three other tests. The draft may change.
Key Findings
- The committee limits Endotest to suspected endometriosis with a normal abdominal and pelvic exam, when ultrasound is negative, inconclusive, declined or unsuitable.
- Three prospective peer-reviewed Endotest studies (200, 200 and 971 people) reported sensitivity of 96% to 97.3%. Specificity ranged from 94.1% to 100%.
- No study reported clinical outcomes, including how long diagnosis or treatment took, or quality of life. Peer-reviewed accuracy studies all came from secondary or tertiary care.
- DotEndo, Endomkit and EndoSure lacked external validation studies. The committee called their accuracy evidence too limited to justify an evidence generation recommendation.
- The four technologies cannot tell endometriosis types apart or gauge disease severity. Endotest costs £1,381 per test and is intended for ages 18 to 43.
Interpretation
The document is a committee draft, and the final advice may differ. The Endotest studies enrolled women with symptoms suggestive of endometriosis. Endometriosis is more common in specialist clinics than in primary care, and the committee calls Endotest accuracy in primary care unclear. The 200-person interim analysis and the 971-person validation study drew on the same cohort. The external assessment group rated the developmental cohort at high risk of bias and the two validation studies at unclear risk. Clinical experts said a negative test should still allow referral when doctors suspect the disease.
RRM Context
NICE puts the average wait for a diagnosis at 9 years and 4 months. Restorative reproductive medicine looks for the cause before treating. A test that shows neither type nor severity leaves that work unfinished. Imaging also misses some types, such as superficial peritoneal endometriosis. Excision is the surgical standard that treats confirmed disease.
Abstract
Second draft guidance (consultation 15 September to 5 October 2026; expected publication 21 January 2027). Recommendation 1.1: Endotest (Ziwig, saliva 109-microRNA signature, CE IVDR class C, ages 18 to 43, GBP 1,381 per test) can be used in the NHS during a 4-year evidence generation period as an option to diagnose endometriosis in primary care, only when clinical examination is normal and ultrasound is negative, inconclusive, declined or not suitable. Recommendation 1.5: more research is needed on DotEndo (DotLab blood microRNA, GBP 400), Endomkit (Camlab/apDia serum BDNF plus CA-125, GBP 28 to 199) and EndoSure (gastrointestinal myoelectrical activity, GBP 350) before NHS funding. Committee noted all peer-reviewed accuracy evidence came from secondary or tertiary care where prevalence is higher than in primary care; the developmental Endotest cohort was judged at high risk of bias and the external validation studies at unclear risk; DotEndo, Endomkit and EndoSure had no external validation studies; no study reported clinical outcomes; the technologies cannot distinguish types of endometriosis or determine severity; clinical experts stated a negative result should not be a reason to deny referral if endometriosis is still suspected; imaging does not identify all types, particularly superficial peritoneal endometriosis. Average time to diagnosis in the UK cited as 9 years 4 months.
