To reduce the diagnostic journey of many women with endometriosis, the High Authority for Health is opening the door to reimbursement for a saliva test deemed “promising,” but is awaiting new data before full reimbursement is possible.
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This test, called Endotest, developed by the Lyon biotech company Ziwig, “showed very good diagnostic performance,” emphasizes the HAS, which has taken measures to evaluate its effectiveness and usefulness.
“It is a clear and strong recognition of our work, it is extremely positive,” Yahya El Mir, the founder and president of Ziwig, told AFP.
Endometriosis is a chronic disease that affects around one in ten women. It usually leads to severe period pain and/or fertility problems.
Even today, diagnosis is often made by chance, with an average delay of seven years.
Reducing this delay to a few days thanks to a saliva test for symptomatic women is nothing other than a “revolution,” praises the founder of the start-up.
How does this test work? “This involves taking a little saliva that contains microRNAs,” explains Yahya El Mir.
Thanks to saliva sampling, it is possible “to get as close as possible to the biological function of cells and to obtain information that cannot be obtained through imaging or surgery and that allows a biological diagnosis. “Sure,” says Mr. El Mir.
The test, which aims to avoid potentially invasive laparoscopy, then involves performing high-throughput sequencing and using an algorithm developed by artificial intelligence.
“High expectations”
A year ago, Inserm (National Institute of Health and Medical Research) remained cautious about the results of an initial study in which only 200 patients took part.
The High Authority for Health issued its opinion on Monday, which was based on expanding the same study to more than 1,000 women with pelvic pain.
Her evaluation found a diagnostic accuracy of 95% for this test, which she considers “promising” and “innovative.”
Although the HAS recognizes “strong patient expectations” for this test, it highlights “the need to conduct additional studies to evaluate its clinical utility in current practice.”
It is therefore initially offering early access via a so-called “innovation package”.
Specifically, if the government follows HAS advice, women over 18 who are “strongly suspected” of having endometriosis will be able to have this test done free of charge.
However, the prerequisite for funding is participation in new studies that make it possible to decide whether or not long-term reimbursement will be granted.
“We are particularly waiting to see whether this test will allow us to improve the treatment strategy,” we explain to the HAS.
“We will make sure that this does not delay access to our test for women in need,” assures the Ziwig founder.
“Incomprehensible”
For patients, the marketing and reimbursement of the test “could be a game-changer,” Priscilla Saracco, director general of the Endomind association, told AFP.
“It is incomprehensible not to quickly take all the necessary measures to make it widely accessible,” the association responded in a press release on Monday. “The refusal to quickly reimburse the saliva test, a global innovation that would finally give answers to thousands of women, disregards the interests of patients,” she said.
The Endotest has been sold in around ten countries in Europe and the Middle East for more than a year, “for around 1,000 euros,” says Ziwig.
“There is no technique more precise than this test,” says Hervé Fernandez, gynecological surgeon and professor emeritus at the University of Paris Saclay. “But we have to ask ourselves what we do with our results and what treatments we can then offer.”
Today, there is no definitive treatment for endometriosis, although hormone therapy and/or surgery can sometimes halt its progression.
Ziwig is working on a second version of the test that will allow disease characteristics to be specified depending on the patient (superficial form of endometriosis, increased risk of infertility, etc.) and treatment to be tailored.