2023-06-21 04:45:00
A simple saliva test might make it very easy to diagnose endometriosis. The first tests are conclusive. How does this test work? Who might benefit from it?
By Coralie Hancok In France, 1.5 million women suffer from endometriosis. © ANNETTE RIEDL / DPA / dpa Picture-Alliance via AFP Published on 06/21/2023 at 06:45
“I had my periods when I was 11 and they have always been painful: I had a stomach ache to the point of not being able to go to college; sometimes the pain made me vomit,” says Delphine, now 42 years old. Attenuated by the pill, the pain returns when the young woman stops it to try to have a child. And it intensifies following her miscarriage in 2009.
The many doctors she consulted then contented themselves with prescribing anti-inflammatories. In 2014, one of them still gave him a laparoscopy which revealed adhesions. Nothing more. And it was not until 2016 that the diagnosis was made: endometriosis. “Finally putting a name to my suffering has greatly relieved me. And that also legitimized her: I was no longer the sissy who listens to herself too much, who is too lazy to go to work, ”recalls Delphine.
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The pain described by Delphine is due to the abnormal presence of the endometrium – the lining of the uterus – elsewhere than in the uterine cavity (in the ovaries, fallopian tubes, bladder, intestines, etc.). During menstruation, the endometrium breaks down, hence menstrual bleeding. But, in women with endometriosis, the misplaced mucosa also bleeds. As the blood cannot be evacuated, it creates hematomas and local inflammation.
Huge hopes
Like Delphine, women suffering from endometriosis – 1.5 million in France and up to 190 million worldwide – often undergo long years of diagnostic wandering: between seven and ten years in France. A long journey strewn with multiple examinations, sometimes invasive: ultrasound, MRI, laparoscopy… In this context, the announcement of the development of a test capable of diagnosing the disease from a simple saliva sample arouses huge hopes.
To develop it, the team of Sofiane Bendifallah, gynecologist-obstetrician at the Tenon hospital in Paris, relied on micro-RNAs. “These are small pieces of RNA involved in the regulation of gene expression and which constitute biomarkers of numerous physiological mechanisms”, explains Sofiane Bendifallah. Thanks to an artificial intelligence algorithm, his team was able, among more than 2,600 microRNAs found in the saliva of his first patients, to discriminate between those which are characteristic of the disease and those which are not. “We have identified 109 micro-RNAs which translate signaling pathways specific to endometriosis”, specifies Sofiane Bendifallah. The results of this first study were published last year in the Journal of Clinical Medicine.
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A few days ago, a second study came to drive the point home. “In order to validate our test, we recruited a new cohort of more than 1,000 patients in 15 different centers. The results for all of these 1,000 patients are not yet available, but those obtained for the first 200 demonstrate that our test is more than 95% sensitive and specific. Obtaining such a precise performance to answer such a complex question is a spectacular step forward,” says Sofiane Bendifallah. Samir Hamamah, head of the reproductive biology department at Montpellier University Hospital, is just as enthusiastic: “This test, which has the immense advantage of being non-invasive, will help improve diagnosis and therefore treatment. »
Marketing and reimbursement to come?
Daniel Vaiman, head of the “From gametes to birth” research team at the Cochin Institute, is more measured: “The approach is promising but, to validate it definitively, it would have been necessary to carry out a randomized study double-blind, which is not the case here. The researcher nonetheless welcomes the idea of using microRNAs as a diagnostic tool. Especially since beyond the diagnosis they might also be used to personalize care. “In the future, we might identify the women who are going to respond best to treatments, those who are most at risk of recurrence… Genetics has made it possible to revolutionize the treatment of cancer. It might be the same for endometriosis, ”says Sofiane Bendifallah.
In the meantime, the gynecologist hopes to convince “by the end of the year” the French health authorities to authorize the marketing, or even the reimbursement by Social Security, of his test called Ziwig Endotest®. A question that is far from trivial insofar as it still costs several hundred euros.
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