Saliva testing takes new step towards care for some women – Editorial

Some women will be able to try a saliva test to diagnose endometriosis: the Supreme Authority for Health gave the green light on Friday, October 18, for treatment through an exceptional system, but is awaiting additional results before a possible procedure. “Extensive and permanent compensation” To better detect this chronic disease that affects about one in ten women.

Lyon Biotech Ziwig now has a clinical study protocol that is considered robust enough, “HAS stands to provide exceptional financial support to Endotest,” Through the so-called “innovation” package, “To allow some patients to access it as quickly as possible,” She said in a press release.

80 volunteer centers

In response to a question from AFP, the Ministry of Health indicated that it would follow HAS's advice. Therefore, some women over the age of 18, who are strongly suspected of having endometriosis, will be able to undergo this test for free in this context. Their treatment will be conditional on participation in a clinical study, which is planned to include 2,500 patients, distributed among 80 volunteer centers.

“The clinical study undertaken in this regard will enable early and safe access to testing and collection of missing data with a view to future evaluation of treatment under common law” and the possibility of “large-scale and permanent reimbursement,” He said he has.

Because if this test is offered “Encouraging the first clinical results and their innovative nature, through the novelty of the indications, their non-invasive nature and their ability to cover a medical need that has not yet been covered,” The data available up to then were judged “insufficient” By the health authority.

Therefore “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 prove its effectiveness.

Marketing in about ten countries

For Endotest, the aim of the study is to evaluate changes in medical decisions associated with the test result – in particular the reduction in laparoscopy procedures – and their appropriateness, according to the description provided by the health authority. The Endotest device has been on sale for about two years in about ten countries in Europe and the Middle East. “About 1000 euros” According to Zweig.

Endometriosis usually results in severe pain during menstruation or fertility problems. To this day, it is diagnosed, often by chance, with an average delay of up to seven years. There is currently no definitive cure for endometriosis, although hormone therapy or surgery can sometimes halt its progression.

“This disease requires robust measures to understand it better, detect it better and manage it better.” Health Minister Genevieve Dariuszk confirmed on Tuesday to Aurelien Rousseau, the former health minister turned NFP MP, who was concerned that measures to treat endometriosis might suffer from a decline in health insurance spending.