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.

Published


Reading time: 1 min

The headquarters of the High Authority of Health (HAS), in Saint-Denis (Seine-Saint-Denis).  (GARO / PHANIE / AFP)

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. Despite everything, HAS is awaiting additional studies.aimed at evaluating its clinical usefulness in current practice” before a possible generalized reimbursement.

Developed by the Lyon biotech Ziwig, this test called Endotest “showed very good diagnostic performance”, underlines the HAS. The latter was 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. Yahya El Mir, founder and president of Ziwig, says 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 would constitute a “revolution”explains the founder of Zwig.

HAS initially offers early access to the test as part of a so-called package “innovation”. SIf his advice is followed, women over 18, 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.


source site-14

Latest