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new step towards support for certain women

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

When questioned, 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 with a view to future evaluation for common law treatment” and 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”, the data available until then were deemed “insufficient” by the health authority.

Sold in around ten countries

The HAS therefore “supported the manufacturer so that it developed a sufficiently robust clinical study protocol to meet the 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 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.

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