Endometriosis: the High Authority for Health paves the way for coverage of a saliva diagnostic test

To reduce the diagnostic wandering experienced by many women with endometriosis, the High Authority for Health is opening the door to the coverage of a saliva test that it considers “promising”, but is awaiting new data before a possible general reimbursement.

The test, called Endotest and developed by the Lyon biotech Ziwig, “showed very good diagnostic performance,” underlines the HAS, which took action to evaluate its effectiveness and usefulness. “It’s a clear and strong recognition of our work, it’s extremely positive,” Yahya El Mir, the founder and president of Ziwig, told AFP.

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Endometriosis is a chronic disease affecting around one in ten women. It usually results in severe pain during periods and/or fertility problems. Even today, it is diagnosed, often by chance, with an average delay of seven years. Reducing this delay to a few days thanks to a saliva test intended for symptomatic women is nothing other than a “revolution”, praises the founder of the start-up.

How does this test work? “It involves taking a little saliva, which contains micro-RNAs,” explains Yahya El Mir. Thanks to saliva sampling, it is possible “to get as close as possible to the biological functioning of cells and produce information that is not obtained through imaging or surgery, and which allows a biological diagnosis to be made. safe,” says Mr. El Mir. The test, which aims to avoid a potentially invasive laparoscopy, then involves carrying out high-throughput sequencing and the use of an algorithm designed by artificial intelligence.

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A year ago, Inserm (National Institute of Health and Medical Research) remained cautious about the results of a first study including only 200 patients. The High Health Authority issued its opinion on Monday based on the extension of this same study to more than 1,000 women suffering from pelvic pain. Her evaluation highlighted a diagnostic accuracy of 95% for this test which she considers “promising” and “innovative”.

Although it recognizes “high expectations” from patients for this test, the HAS nevertheless emphasizes “the need to carry out additional studies aimed at evaluating its clinical usefulness in current practice”. Consequently, it initially offers early access, via a so-called “innovation” package. This allows, specifies the HAS on its website, “exempt and temporary support to facilitate early access for patients to innovative technologies (health technologies other than medicines) in the early phase of clinical development”. 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, however, is “conditional” on participation in new studies, which will make it possible to decide whether or not in favor of long-term reimbursement. “We are particularly waiting to know if this test will make it possible to improve the treatment strategy,” we explain to the HAS. “We will be careful to ensure that this does not delay access to our test for women in need,” assures the founder of Ziwig.

For patients, the marketing and reimbursement of the test could “be a game changer,” Priscilla Saracco, general director of the Endomind association, told AFP. “It is incomprehensible not to quickly take all the necessary measures to make it widely accessible,” the association reacted in a press release on Monday. “The refusal to provide rapid reimbursement for the saliva test, a global innovation which would allow thousands of women to finally obtain answers, disregards the interests of patients,” according to her. The Endotest has been sold for more than a year in around ten countries in Europe and the Middle East, “at around 1,000 euros”, according to Ziwig.

However, “there is no technique more precise than this test,” says Hervé Fernandez, gynecological surgeon, professor emeritus at Paris Saclay University. “But we have to 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.