the High Authority for Health opens the way to a saliva test deemed “promising”

HAS is nevertheless awaiting additional studies before possible widespread reimbursement for this disease which affects around one in ten women.

The High Authority for Health (HAS) proposed Monday January 8 that certain women could have access to a saliva test “promising” aimed at diagnosing endometriosis, a chronic disease which affects around one in ten women and usually results in severe pain during periods or fertility problems. HAS is nevertheless awaiting additional studies before possible generalized reimbursement.

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

Reliability of around 95%, according to initial studies

The reliability of this saliva sample is around 95%, according to the first studies carried out. According to Yahya El Mir, founder and president of Ziwig, 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 reliable biological diagnosis to be made.”

Endometriosis is often diagnosed 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 “revolution”according to the founder of Zwig.

“If it recognizes the innovative nature and diagnostic effectiveness of this test”, the High Health Authority underlines “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 package. “innovation”.

Concretely, if his advice is followed, women over 18 years old, for whom endometriosis is strongly suspected, could in the coming months carry out this test free of charge (marketed in other countries, such as Switzerland, for around 800 euros) . This support will be “conditioned” to participation in new studies, which will make it possible to decide whether or not in favor of long-term reimbursement.