To reduce the diagnostic wandering experienced by many women with endometriosisthe High Authority for Health (HAS) opens a door to a saliva test deemed “promising”, but awaits new data before possible widespread reimbursement. Developed by the Lyon biotech Ziwig, this test, called Endotest, “showed very good diagnostic performance”, underlines the HAS, which took action in order to evaluate its effectiveness and clinical usefulness.
A chronic disease affecting around one in ten women, endometriosis usually results in severe pain during periods and/or fertility problems. Even today, it is diagnosed, often 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 is a “revolution”, praises the founder of the start-up.
How does the test work?
“Our test allows us to put a name to frequent and disabling symptoms,” according to Yahya El Mir, the founder and president of Ziwig. “It involves taking a little saliva, which contains micro-RNAs,” he explains. Because endometriosis “is not a purely gynecological disease”.
Thanks to saliva sampling, 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. “, he still asserts.
What do doctors think?
“The technique used is attractive, because the test is very simple,” judges Louis Marcellin, gynecologist at Cochin hospital (AP-HP). The test then involves carrying out high-throughput sequencing and using an algorithm designed by artificial intelligence. A year ago, Inserm (National Institute of Health and Medical Research) remained cautious about the results of a first study including only 200 patients.
The High Authority for Health issued its opinion on Monday based on the extension of this same study to more than 1,000 women suffering from pelvic pain. Her evaluation highlighted a diagnostic accuracy of 95% for this test which she considers “promising” and “innovative”.
While it recognizes “strong expectations” from patients for this test, the HAS underlines “the need to conduct additional studies aimed at evaluating its clinical usefulness in current practice”. Consequently, it initially offers early access, via a so-called “innovation” package.
A free test? Paying?
Concretely, if the advice of the HAS is followed by the government, women over 18 years of age, for whom endometriosis is “strongly suspected”, will be able to carry out this test free of charge. Support “conditional” on participation in new studies, which will make it possible to decide whether or not in favor of long-term reimbursement. “We are particularly waiting to know if this test will make it possible to improve the treatment strategy,” we explain to the HAS.
For patients, the marketing and reimbursement of the test could be a “game changer,” says Priscilla Saracco, executive director of the Endomind association. “In addition to the delay in diagnosis, there is also today a big territorial inequality, with women who do not have access to expert centers or trained radiologists,” she adds.
What results abroad?
The Endotest has been sold for more than a year in around ten countries in Europe and the Middle East. For example, it is sold in Switzerland for around 800 euros.
“There is no technique more precise than this test,” says Hervé Fernandez, gynecological surgeon, professor emeritus at Paris Saclay University. “But we have to ask ourselves what we are going to do with our results, what treatments we will then be able to offer.”
Today, there is no definitive treatment for endometriosis, although hormonal therapy and/or surgery can sometimes stem its progression. Ziwig is working on a second version of the test which will be able to specify the characteristics of the disease depending on the patient (superficial form of endometriosis, increased risk of infertility, etc.), to adjust treatments.