PSF 2024 – Endometriosis: what will the saliva diagnostic test change?

PSF 2024 – Endometriosis: what will the saliva diagnostic test change?
PSF 2024 – Endometriosis: what will the saliva diagnostic test change?

Nine out of 10 women with endometriosis say in retrospect that their quality of life would have been better if they had had an early diagnosis. However, the average diagnosis time for the disease remains between 7 and 10 years. Faced with this assessment, “ real topic of discussion » for the scientific community, the availability of the Endotest saliva diagnostic test will be a game-changer and will disrupt the lives of the women concerned and their care pathway, explained Professor Sofiane Bendifallah (American Hospital, Paris) during the Pari(s) congress ) Women’s Health (June 12-14, 2024, Paris).

« Even if we have improved our listening and the examinations carried out, there are still many forms which are not or poorly diagnosed in imaging, such as superficial, millimetric or peritoneal forms.recognized the obstetrician-gynecologist. However, these forms represent the vast majority of endometriosis diagnoses. This explains the discrepancy between what women report to us and the results of our imaging. » According to a study by the EndoFrance and Endomind associations, 65% of them had to carry out numerous examinations, i.e. at least 3 ultrasounds and a quarter of them had surgical intervention to obtain a diagnosis.

The arrival of the Endotest saliva test therefore constitutes a real revolution. This is based on the analysis of salivary microRNAs by high-throughput sequencing. In practice, endometrial samples show the presence of microRNAs specific to the pathophysiology of the disease, which can constitute biomarkers: it is possible to find them in all biological fluids including blood. Some of them are there in encapsulated form; thus protected, this fraction can be found in saliva. Using artificial intelligence, a specific molecular signature of the disease was established based on 109 microRNAs. The test, thus developed, has a sensitivity, specificity and AUC (area under curve) all greater than 95% according to the study which was carried out among 1,153 women from 18 centers in France. In December 2023, the HAS (High Authority for Health) confirmed its clinical usefulness. A new study will begin in the fall in 80 level 2 and 3 centers which will be able to use and evaluate it in clinical practice. This study will compare the impact of the test on the decision-making and management of patients.

Clarification of the diagnostic strategy

An algorithm has already been established by learned societies and will serve as a basis for this study: faced with a symptomatic woman, the prescription of imaging remains the first step in the process when the history and clinical examination suggest endometriosis. If the result is negative, the diagnostic test must be offered. “ Announcing the result of the diagnostic test requires education, information on the principle, reliability and place of the test in relation to imaging, but also listening to women who often have a very long journey behind them. “, he insisted. When the test is positive, the prescription of hormonal treatments is relevant and must be personalized. We must also take the time to reduce adverse effects, comorbidities, prevent infertility, take early care of the impact on mental, social, professional health, etc. “ This completely changes the nature of the dialogue with these women in whom imaging had not made it possible to establish the name of the disease and where the discussion always revolved around this diagnostic uncertainty. Given the power of the test, they will be both more confident in the result and in the proposed care pathway. » And if the test is negative, concluded Professor Bendifallah, this means that “ the hormonal prescription is no longer entirely logical since the suspicion of endometriosis has fallen. We are entering a new period. [Si le test est négatif], these are women who suffer from chronic pain which has another origin, and who deserve to be taken care of. There are probably thousands of them and, among them, it will be necessary to continue the investigations to propose an evolution of the care ».

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