Endometriosis Saliva Test Faces Scrutiny Despite French Health Coverage
Paris, France - A new saliva test for endometriosis, marketed by French start-up Ziwig as “Endotest,” is receiving meaningful criticism from the scientific community despite being reimbursed by French health insurance. The test, currently covered for up to 25,000 women with a budget of 21 million euros, has been approved under an “innovation package” by the High Authority for Health (HAS), even as experts question its reliability due to limited patient sample sizes in initial studies.
Endometriosis, a painful condition were tissue similar to the lining of the uterus grows outside of it, currently relies on often-delayed and invasive diagnostic methods like laparoscopy. Endotest aims to offer a non-invasive option.
The HAS initially acknowledged insufficient clinical data to definitively prove a positive impact on patient care when first evaluating the test. Though, they subsequently approved exceptional financial support through the innovation package, allowing access for patients while requesting further data from Ziwig. The HAS evaluation ultimately demonstrated a diagnostic accuracy of 95% after the study expanded to over a thousand patients in endometriosis reference centers.
Despite this, concerns persist. Bianca Schor, a researcher in artificial intelligence applied to women’s health at the University of Amsterdam, questioned the generalizability of the test, stating, “Can we generalize a tool which was based on only one population?”
Initial studies cited by Ziwig - one published in the Journal of Clinical Medicine in early 2022 with 200 patients, and another in records in 2023 – were indeed conducted on relatively small groups. British statistician Kevin McConvay described the initial 200-patient study as ”really a starting point.”
Yahya El Mir, president of Ziwig, defends the test’s methodology, asserting, “There is no product on a global scale that has this quality.” Currently, 100 centers across France offer the Endotest.
The debate highlights the tension between the need for innovative diagnostic tools for endometriosis and the importance of rigorous scientific validation before widespread implementation and public funding.
