three questions on the saliva test that the High Authority of Health considers “promising”

Developed by the Lyon biotech Ziwig, the Endotest, supposed to allow a precise and rapid diagnosis of endometriosis, will be the subject of “additional studies”, according to the assessment of the High Authority of Health made on Monday.

Will the years of medical wandering cease to be inevitable for people suffering from endometriosis? In any case, this is what the evaluation of the High Authority of Health (HAS) on the Salivary Endotest, delivered on Monday January 8, suggests. Qualified for “promising”, This test makes it possible to avoid unnecessary surgical intervention, particularly for patients with symptoms similar to endometriosis but not carriers of this chronic disease.

Endometriosis causes severe pelvic pain, whether menstrual or not depending on the stage, and can go so far as to cause infertility. One in 10 women of childbearing age are affected. Does this test really constitute a “revolution” for them, as its founder, Yahya El Mir, asserts? Franceinfo takes stock.

1 What does this test consist of?

The Endotest comes in the form of a kit with a plastic tube inside, into which you have to spit. Much less invasive than a pelvic ultrasound or laparoscopy, it only requires this saliva sample to detect endometriosis in menstruating people, aged 18 to 43. The diagnosis is then based on high-throughput sequencing technology and uses artificial intelligence. This new tool was developed by theZiwig company, founded in 2019 in Lyon.

A year ago, the National Institute of Health and Medical Research (Inserm) remained cautious about the results of a first study including only 200 patients. On Monday, the HAS was more optimistic: its opinion is based this time on the extension of this same study, carried out on more than 1,000 women suffering from pelvic pain. It initially offers early access, via a package called “innovation”. Concretely, if the opinion of the HAS is followed by the government, women over 18 years old, for whom endometriosis is “strongly suspected”, will be able to perform this test free of charge. However, support is “conditional” on participation in new studies.

2 Is it already used in other countries?

The Endotest is marketed in 17 countries in Europe and the Middle East. Switzerland was the first country to offer access. In June 2022, it becomes available for sale on the website of the medical analysis laboratory Labor Team w ag, at the price of 781.20 Swiss francs (or approximately 712 euros). A sum explained by the use of NGS (new generation sequencing) machines, which are extremely expensive, according to the S-Endo association.

It will soon be available in Canada, United States, Australia, New Zealand, China, Japan, Southeast Asia, Israel, Greece, Poland, Spain, Portugal and ‘MAURITIUS. In France, its placing on the market and its price depend on the opinion that the government will give: in the event that it aligns with that of the HAS, women over 18 years of age, for whom endometriosis is “strongly suspected”will be able to carry out this test free of charge.

3 What will this change?

An average time of seven years to obtain a diagnosis, a laparoscopy which involves general anesthesia, a pelvic ultrasound often experienced as distressing… So many situations which could be avoided if the saliva test were to be marketed and reimbursed by Social Security . This medical tool, deemed to comply with European Union requirements in terms of safety, health and environmental protection, delivers a result in less than a week.

Another advantage: the Endostest makes it possible to detect all types of endometriosis, from superficial to deep forms, including in complex patient cases. “discordant”, that is to say those whose symptoms suggest endometriosis, despite medical treatment suppressing periods and normal clinical and radiological examinations. In addition, hormonal treatment has no impact on the result. Above all, the Endotest helps avoid unnecessary surgical intervention, particularly for patients suffering from symptoms suggestive of endometriosis but who do not have this chronic disease.

Ziwig is working on a second version of the test with the aim of identifying the characteristics of the disease based on the patients. The point of such a degree of precision? Adjust treatments. Although it is, to date, impossible to cure endometriosis, hormonal therapy and surgery can sometimes stem its progression.