Endometriosis test back by French government faces scrutiny

When France launched a national strategy against endometriosis in 2022, the centrepiece was a saliva-based diagnostic test hailed as a medical breakthrough. But after years of government backing, researchers are questioning whether the so-called Endotest lives up to its promise. Endometriosis, a chronic condition in which tissue similar to the uterine lining grows outside the womb, affects at least one in ten women of reproductive age worldwide. It causes severe pain and often leads to infertility. Currently, diagnosis typically requires invasive surgery under general anaesthesia, making a simpler, non-invasive tool highly sought after. The Endotest, developed by Lyon-based start-up Ziwig, requires only a saliva sample. Using artificial intelligence and microRNA technology, the company claims it can detect all forms of the disease, even complex cases. Ziwigs founders have spoken of a revolution in womens health, while the French government has provided reimbursement for patients taking the test, an investment expected to cost taxpayers 21 million. Officials have strongly promoted the project. Former health minister Genevive Darrieussecq described it as a showcase of French excellence, while current minister Catherine Vautrin publicly endorsed the lab earlier this year, a rare move in the biotech sector. But experts caution that scientific evidence is still thin. Two studies often cited by Ziwig, one published in Journal of Clinical Medicine in 2022, the other in NEJM Evidence in 2023, have been described as important first steps but not sufficient external validation. Critics note that one studys 200 participants were all French patients already considered likely to have the disease, raising questions about how widely the results can be applied. Frances independent health authority HAS concluded that the test showed validated diagnostic performance but recommended it only be reimbursed after other imaging fails, not as a tool for early detection. Meanwhile, some researchers argue that the heavy state investment in one test comes at the expense of broader research. Inserm professor Ludivine Doridot said the 11 million budgeted for endometriosis research overall is half of what is being spent on the Endotest, warning that such funding will not help other companies develop technologies that could have a positive impact in the future. Ziwig co-founder Yahya El Mir defended the product, telling AFP there was no other product worldwide that has this quality and insisting that published data supports its effectiveness. He said additional peer-reviewed publications are pending. Patient advocacy groups remain split. Endomind has pushed for wider access to the test, but other voices are more sceptical. Former government adviser and endometriosis patient Arounie Tavenet argued that political backing has been overstated: We could have hoped for accelerated processes for what is presented as a national priority rather than exaggeratedly supporting the evaluation of a saliva test that raises ethical concerns and, ultimately, does not represent a major advance for patients.The post Endometriosis test back by French government faces scrutiny appeared first on Linda Ikeji Blog.