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This January 8, the High Authority of Health wants to improve the diagnosis of endometriosis, by recognizing the usefulness of the Endotest®, a “promising” saliva test. If the solution cannot yet qualify for generalized reimbursement, it will allow early access as part of the “innovation package”.
One in 10 women suffer from endometriosis in France. And 2 million adult women are currently likely to wonder if this condition is the cause of their chronic pelvic pain during menstruation or fertility problems. Despite everything, diagnosing this pathology still remains complicated and time-consuming. But even today, it is diagnosed, often by chance, with an average delay of seven years.
To reduce this diagnostic error, the High Authority of Health (HAS) has initiated self-referral in order to evaluate the effectiveness and clinical usefulness of the saliva diagnostic test Endotest®, designed by the Lyon biotech Ziwig, with a view to reimbursement . A hope for many women.
The performance of the Endotest® recognized, in 3rd intention
Today, the diagnosis of endometriosis is based primarily on a clinical examination, and 2e intention on an imaging assessment (a pelvic ultrasound and a pelvic MRI). A laparoscopy can be considered, to confirm the diagnosis of endometriosis, if a surgical therapeutic project shared with the patient is associated with it. But like any surgical procedure, the laparoscopic examination is invasive and does not guarantee improvement.
The Endotest® stands out here as a welcome non-invasive solution that would reduce the time before a diagnosis. “Our test allows us to put a name to frequent and disabling symptoms“, declared to AFP Yahya El Mir, the founder and president of Ziwig. Reducing this delay to a few days thanks to a saliva test intended for symptomatic women is none other than a “revolution”, praises the founder of the start-up.
“This involves taking a little saliva, which contains micro-RNA“, explains Yahya El Mir. Because endometriosis “is not a purely gynecological disease“. The saliva test does not fall into the category of rapid diagnostic orientation tests (TROD), but it can be collected by the patient herself, in order to be sequenced and read by artificial intelligence within a specialized medical biology laboratory.
“The technique used is attractive, because the test is very simple“, judge Louis Marcellin, gynecologist at Cochin hospital (AP-HP).
A year ago, Inserm (National Institute of Health and Medical Research) remained cautious about the results of a first study including only 200 patients.
In its opinion based on the extension of this same study to more than 1,000 women suffering from pelvic pain, the HAS recognizes very good diagnostic performance for Endotest® (95% sensitivity and 94% specificity) and underlined the high expectations and the significant potential of this test in the patient management strategy. She recognizes the usefulness of the third-line saliva test in diagnostic research:
- In patients aged 18 and over of childbearing age, for whom endometriosis is strongly suspected and presenting pelvic pain not controlled by empirical medical treatment or having a desire to become pregnant;
- To reduce the number of unnecessary laparoscopies performed in these patients, when the reference imaging findings are negative or uncertain.
Not yet reimbursed, but eligible for the innovation package
However, for the HAS, it is still too early to demonstrate the “clinical” usefulness of the Endotest®. For the moment, the data transmitted by the manufacturer do not make it possible to demonstrate whether the saliva test would have a real impact in patient care. In this context, long-term reimbursement cannot be offered. On the other hand, the innovative nature of the solution allows it to be included in the innovation package.
Concretely, if the advice of the HAS is followed by the government, women over 18 years of age, for whom endometriosis is “strongly suspected”, will be able to carry out this test free of charge.
Support “conditioned” on participation in new studies, which will make it possible to rule or not in favor of long-term reimbursement.
“In particular, we are waiting to know if this test will make it possible to improve the management strategy.“, we explain to the HAS. The impact of the test on patient care, an estimate of the volume of test prescriptions in the target population, the acceptability of patients in particular.
For patients, the marketing and reimbursement of the test could be a “game changer”, Priscilla Saracco, general director of the Endomind association, told AFP.
“In addition to the delay in diagnosis, there is also today a big territorial inequality, with women who do not have access to expert centers or trained radiologists.“, she adds.
The Endotest has been sold for more than a year in around ten countries in Europe and the Middle East. For example, it is sold in Switzerland for around 800 euros.
“There is no technique more precise than this test“, says Hervé Fernandez, gynecological surgeon, professor emeritus at Paris Saclay University. “But we must ask ourselves what we are going to do with our results, what treatments we will then be able to offer.“.
Today, there is no definitive treatment for endometriosis, although hormonal therapy and/or surgery can sometimes stem its progression.
Ziwig is working on a second version of the test which will be able to specify the characteristics of the disease depending on the patient (superficial form of endometriosis, increased risk of infertility, etc.), to adjust treatments.