The High Authority for Health gives the green light for the experimentation of the saliva test to diagnose endometriosis

The Lyon biotech Ziwig now has a clinical study protocol considered sufficiently solid, “HAS decides in favor of exceptional financial support for Endotest“, via a package called “innovation“, “to allow certain patients to access it as quickly as possible“, she said in a press release.

Questioned by AFP, the Ministry of Health indicated that it would follow the advice of the HAS.

Certain women over the age of 18, for whom endometriosis is strongly suspected, will therefore be able to carry out this test free of charge in this context.
Their treatment will be conditional on participation in a clinical study, which plans to include 2,500 patients, spread across 80 voluntary centers.
“The clinical study carried out in this regard will make it possible to provide early and secure access to the test and to collect missing data for future evaluation for common law treatment.“and a possible”broad and lasting reimbursement“, specified the HAS.
Because if this test displays “encouraging first clinical results and an innovative character, by its novelty in the indication, its non-invasive nature and its potential to cover a medical need which is not yet covered“, the data available until then were judged”insufficient” by the health authority.

You have to donc”supported the manufacturer to develop a clinical study protocol robust enough to meet entry requirements” in the innovation package, according to its press release.

This exceptional and temporary support system aims to facilitate patients’ access to innovative technologies, by allowing financial support from the implementation of the clinical study to establish proof of its effectiveness.

For Endotest, the objective of the study is to evaluate the changes in medical decisions linked to the result of the test – in particular the reduction in laparoscopies -, and their relevance, according to the description made by the health authority.
The Endotest has been sold for almost two years in around ten countries in Europe and the Middle East, “at around 1,000 euros”, according to Ziwig.
A chronic disease that affects around one in ten women, endometriosis 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. There is currently no definitive treatment for endometriosis, although hormonal therapy and/or surgery can sometimes stem its progression.
“This disease requires strong measures in order to better understand it, better detect it and better manage it,” assured Tuesday the Minister of Health Geneviève Darrieussecq to Aurélien Rousseau, former Minister of Health who became NFP deputy, who He was concerned that measures for endometriosis could suffer from reduced health insurance costs.