Saliva-based test validated as diagnostic tool for endometriosis

The first saliva-based test for endometriosis has been validated as a diagnostic tool for the condition affecting 190 million women globally.

The Endotest, developed by the French biotech company Ziwig, is a prescriptive-use only device for female patients clinically suspected of endometriosis between the age of 18 and 43.

The test works by measuring levels of certain biomarkers that are present in the saliva of women with endometriosis, aiming to provide a reliable and robust diagnosis of the disease within seven days.

Ziwig has announced the scientific validation of its Endotest following a study published in the NEJM Evidence journal.

The results, the company said, confirmed the performance and reproducibility of the test with sensitivity and specificity of over 95 per cent, making it the only non-invasive diagnostic tool of unquestionable effectiveness and an alternative to surgery.

In addition, the study’s demonstration of the effectiveness of the combination of Next Generation Sequencing (NGS) and Artificial Intelligence (AI) heralds the imminent advent of new non-invasive tools for predicting response to treatment, the start-up added.

Professor Horace Roman, founder of the Franco-European Multidisciplinary Institute of Endometriosis IfemEndo Bordeaux, described the test as “a revolution in diagnosis, with tremendous prospects for patient”, while Professor Samir Hamamah, head of the reproductive biology department at Montpellier University Hospital, said early diagnosis of endometriosis would enable the condition to be identified and treated more quickly.

Priscilla Saracco Ollagnier, ENDOmind France director general, said: “It’s about time that a revolutionary, easy-to-use tool is finally available to the millions of women suffering from endometriosis (…) to help them preserve their fertility and quality of life.

“This test is a revolution, of course for young women with endometriosis who will finally be able to have a quick and reliable answer, but also for those who ultimately do not have endometriosis.

“There are other pathologies and syndromes that cause very similar symptoms and it is finally time to bring them to light so that all women can be taken care of properly.”

The Endotest is currently available in Switzerland, the UK, Italy, Germany, Sweden, Norway, Denmark, Iceland, Lithuania, Latvia, Estonia, Saudi Arabia and the United Arab Emirates and will soon be available in Hungary, Belgium, Luxembourg, Kuwait, Qatar and Israel.

In France, Ziwig has confirmed it is working closely with the relevant health authorities to make the test available to healthcare professionals and patients by the end of 2023.