the High Health Authority paves the way for coverage of the saliva test

2024-01-08 14:12:01

The High Health Authority recommends the establishment of an “innovation package” to reimburse a “promising” saliva test aimed at diagnosing endometriosis.

The High Authority for Health (HAS) proposed this Monday, January 8 that certain women might have access to a “promising” saliva test aimed at diagnosing endometriosis, but it is awaiting additional studies before possible widespread reimbursement.

Developed by the Lyon biotech Ziwig, this test, called Endotest, “showed very good diagnostic performance”, underlines in a press release the HAS, which took action in order to evaluate, with a view to reimbursement, its effectiveness and its clinical usefulness.

According to the first studies carried out, its diagnostic accuracy is around 95%.

One in ten women

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.

Reducing this delay to a few days thanks to a saliva test intended for symptomatic women is nothing other than a “revolution”, according to the founder of the start-up.

Need for further studies

“While it recognizes the innovative nature and diagnostic effectiveness of this test”, the High Health Authority underlines on 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 his advice is followed, women over 18 years old, for whom endometriosis is strongly suspected, might in the coming months carry out this test free of charge (marketed in other countries, such as Switzerland, for around 800 euros) .

Support “conditioned” on participation in new studies, which will make it possible to rule or not in favor of long-term reimbursement.

We are particularly waiting to know if this test will make it possible to improve the management strategy for patients with endometriosis,” we explain to the HAS.

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