
The French National Authority for Health (HAS) has deemed a saliva test for endometriosis “promising” after carrying out its own clinical testing, in a move that could lead to the test being 100 per cent reimbursed for eligible patients.
The French health authorities will allow early access to the diagnostic test as part of a scheme as it collects more data on the test’s effectiveness.
The Endotest, developed by the French biotech company Ziwig, works by measuring levels of certain biomarkers that are present in the saliva of women with endometriosis, aiming to provide a reliable diagnosis of the disease within seven days.
The device, which was validated as a diagnostic tool for endometriosis last year following a study published in the NEJM Evidence journal, could mark a major advance in the diagnosis of the condition, which affects roughly 190 million women and girls of reproductive age worldwide.
Yahya El Mir, founder of Ziwig, said: “This is an important moment for women suffering from endometriosis, a disease that is often difficult to diagnose.
“Ziwig Endotest promises a reliable, rapid and non-invasive diagnosis, dramatically reducing diagnostic wandering for thousands of patients.
“The test stands out as a non-invasive approach due to its breakthrough technology combining RNA analysis and artificial intelligence.
“This technology offers an alternative to traditional diagnostic processes, which are often lengthy, operator-dependent and invasive and provides fast and reliable results.”
The recognition by the HAS, Ziwig said, is a testimony to the potential of its technology, which is not limited to endometriosis.
The company said: “Our aim is to develop salivary diagnostics for other gynaecological pathologies, as well as in the fields of oncology and neurology, based on this same innovative technology.”
The Endotest is currently available in the UK, Switzerland, Italy, Germany, Sweden, Norway, Denmark, Iceland, Lithuania, Latvia, Estonia, Saudi Arabia and the United Arab Emirates.
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