“Very good diagnostic performance.” The High Health Authority, acting on its own, has evaluated the effectiveness and usefulness of a saliva test designed to detect endometriosis, a test that the health authority described on Monday as “promising.”
“This test could be useful in patients over 18 years of childbearing age, in whom endometriosis is strongly suspected,” highlights the HAS in its press release.
Endometriosis, a chronic disease that affects approximately one in ten women, usually causes severe pain during menstruation and/or fertility problems. Even today, it is diagnosed, often by chance, with an average delay of seven years.
A simple saliva test
The test, called Endotest, has been developed by Lyon biotechnology company Ziwig. It consists of a sample of “a little saliva that contains microRNA,” explains Yahya El Mir, founder of Ziwig.
Thanks to taking saliva samples, it is possible to “get as close as possible to the biological functioning of the cells and produce information that cannot be obtained through images or surgery, and that makes it possible to ensure a biological diagnosis,” says Yahya El Mir.
The test aims to avoid laparoscopy, a surgical intervention that “is not trivial and presents risks”, as the High Health Authority points out: “it may be useless, either because lesions characteristic of the disease are not found, or because even once withdrawn, the woman’s health does not improve.
In this case, the saliva sample only involves high-throughput sequencing and the use of an algorithm designed by artificial intelligence.
“Additional studies” before general reimbursement
While recognizing “high expectations” from patients regarding this test, the HAS underlines “the need to conduct additional studies aimed at evaluating its clinical usefulness in current practice.” Consequently, it initially offers early access, through the so-called “innovation” package.
Specifically, if the government follows the advice of the HAS, women over 18 years of age, in whom there is “high suspicion” of endometriosis, will be able to take this test for free. The support, however, is “conditional” on participation in new studies, which will make it possible to decide whether or not long-term reimbursement is favored.
The Endotest is currently sold in a dozen countries in Europe and the Middle East “for about 1,000 euros,” according to Ziwig. A very high cost due to the sequencing technique used by biotechnology.
A new version of the test in preparation
“There is no more precise technique than this test,” says Hervé Fernández, gynecological surgeon and professor emeritus at Paris Saclay University. “But we have to ask ourselves what we are going to do with our results, what treatments we can offer next.”
Today, there is no definitive treatment for endometriosis, although hormone therapy and/or surgery can sometimes stop its progression.
Ziwig is working on a second version of the test that 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.
Source: BFM TV
