A saliva test to diagnose endometriosis, called Endotest, was developed by Lyon biotech Ziwig. Its diagnostic accuracy is around 95%, according to the first studies carried out.
The hope is such that High health authority (HAS) proposed this Monday that certain women could benefit from coverage for this test, pending additional studies and possible generalized reimbursement.
How does this test work?
“It involves taking a little bit of saliva, which contains micro-RNA,” explains Ziwig founder and president 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. sure,” continues Yahya 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.
“Additional studies necessary”
“If it recognizes the innovative nature and diagnostic effectiveness of this test”, the High Authority of Health underlines this Monday “the need to carry out additional studies aimed at evaluating its clinical usefulness in current practice”. It therefore initially offers early access to this test as part of a so-called “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, however, is “conditional” on participation in new studies, which will make it possible to decide whether or not in favor of long-term reimbursement.
For patients, the marketing and reimbursement of the test would completely change the situation.
Also, Priscilla Saracco, general director of the Endomind association, is surprised: “It is incomprehensible not to quickly take all the necessary measures to make it widely accessible,” she reacted.
“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.
Already sold in around ten countries
The Endotest has already been sold for more than a year in around ten countries in Europe and the Middle East, “at around 1000 euros”, according to Ziwig.
“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 in fact no definitive treatment for endometriosis, even if hormonal therapy and/or surgery can sometimes stem its progression.