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ENDOBEST study: clinical evaluation of the saliva test in endometriosis


Clinical background


Endometriosis affects up to 10% of women of childbearing age and represents a major diagnostic challenge. In patients with suggestive symptoms, the actual prevalence of endometriosis is estimated to be between 33% and 74%¹.


However, diagnosis remains complex: there are long delays before treatment begins, the symptoms are debilitating, and there is often a discrepancy between clinical findings and imaging results.


To date, no biological marker has proven useful in aiding diagnosis. It is in this context that the IFEM Endo centre is participating in the ENDOBEST study (NCT06794424), launched in May 2025, which is exploring the clinical value of a new non-invasive saliva test.



The Ziwig Endotest®: validation data


The Ziwig Endotest® is based on next-generation sequencing of salivary microRNAs (miRNAs).


Two recent studies (ENDOmiARN: NCT04728152 and ENDOmiARN Saliva Test: NCT05244668) have established its diagnostic performance(3-5):

  • Sensitivity: 0.96 [95% CI: 0.93-0.97]

  • Specificity: 0.95 [95% CI: 0.85-0.99]⁴

Boite du test diagnostic de l'endométriose Ziwig Endotest®

However, these promising results need to be validated in real-world clinical practice, which is precisely the objective of the EndoBest study.


Purpose of the study


ENDOBEST assesses the impact of saliva testing on gynaecologists' treatment strategies.


This is a change-in-management study: for each patient, the treatment decision is documented before and after the test result is known, allowing analysis of how the test actually changes the clinical approach (monitoring, additional tests, diagnostic laparoscopy).



Methodology


Target population

  • 2,500 patients planned across France

  • Nearly 1,500 patients already included (data as of October 2025)

  • Inclusion criteria: women aged 18 to 43 with symptoms suggestive of endometriosis and imaging findings that are inconsistent with the clinical picture


Procedure

After consulting with the radiologist, the gynecologist documents the following in the eCRF:

  1. The initial management strategy (blind to the test result)

  2. The strategy after learning the result of the saliva test


Duration 18 months in total, with results expected in 2026.



References

1.  Guo, S.-W. & Wang, Y. The prevalence of endometriosis in women with chronic pelvic pain. Gynecol Obstet Invest 62, 121–130 (2006).

2.  Becker, C. M. et al. ESHRE guideline: endometriosis†. Human Reproduction Open 2022, hoac009 (2022).

3.  Bendifallah, S. et al. A Bioinformatics Approach to MicroRNA-Sequencing Analysis Based on Human Saliva Samples of Patients with Endometriosis. Int J Mol Sci 23, 8045 (2022). 

4.  Bendifallah, S. et al. Validation of a Salivary miRNA Signature of Endometriosis - Interim Data. NEJM Evid 2, EVIDoa2200282 (2023).

5.  Bendifallah, S. et al. Salivary MicroRNA Signature for Diagnosis of Endometriosis. J Clin Med 11, 612 (2022).

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