To reduce the diagnostic error suffered by many women with endometriosis, the French National Authority for Health is opening the door to the reimbursement of a saliva test deemed "promising", but is waiting for new data before a possible generalized reimbursement.

Developed by the Lyon-based biotech company Ziwig, this test, called Endotest, "has shown very good diagnostic performance," says the HAS, which has taken up a self-referral to assess its effectiveness and usefulness.

"It's a clear and strong recognition of our work, it's extremely positive," Yahya El Mir, founder and chairman of Ziwig, told AFP.

Endometriosis is a chronic disease that affects about one in ten women and usually results in severe pain during menstruation and/or fertility problems.

Read alsoEndometriosis: a little-known disease that affects 10% of women

Even today, it is diagnosed, often by chance, with an average delay of seven years.

Reducing this time to a few days thanks to a saliva test for symptomatic women is nothing less than a "revolution", boasts the founder of the start-up.

How does this test work? "It's about taking a little bit of saliva, which contains microRNAs," says El Mir.

Thanks to saliva sampling, it is possible "to get as close as possible to the biological functioning of cells and to produce information that is not obtained by imaging or surgery, and which makes it possible to make a reliable biological diagnosis," says Yahya El Mir.

March 25, 2017 in Paris © Zakaria ABDELKAFI / AFP/Archives

The test, which is intended to avoid potentially invasive laparoscopy, then involves high-throughput sequencing and the use of an algorithm designed by artificial intelligence.

95% accuracy

A year ago, the Inserm (French National Institute of Health and Medical Research) remained cautious about the results of an initial study involving only 200 patients.

The French National Authority for Health issued its opinion on Monday on the basis of the extension of this same study to more than 1,000 women suffering from pelvic pain.

Its evaluation showed a diagnostic accuracy of 95% for this test, which it considers "promising" and "innovative".

While acknowledging patients' "high expectations" for this test, the HAS stresses "the need to conduct additional studies to assess its clinical utility in routine practice".

As a result, it initially offers early access, via a so-called "innovation" package.

In concrete terms, if the advice of the HAS is followed by the government, women over the age of 18, for whom endometriosis is "strongly suspected", will be able to carry out this test free of charge.

However, this coverage is "conditional" on participation in new studies, which will make it possible to decide whether or not to reimburse the employee in the long term.

"In particular, we are waiting to find out whether this test will improve the management strategy," explains the HAS.

A €1,000 test

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 said in a statement on Monday. "The denial of rapid reimbursement for the saliva test, a global innovation that would allow thousands of women to finally get answers, disregards the interests of patients," she said.

The endotest has been sold for more than a year in a dozen countries in Europe and the Middle East, "at around 1,000 euros", according to Ziwig.

"There is no more precise technique than this test," says Hervé Fernandez, a gynaecological surgeon and professor emeritus at the University of Paris Saclay. "But we have to ask ourselves what we're going to do with its results, what treatments we're going to be able to offer next."

Today, there is no definitive treatment for endometriosis, although hormone therapy and/or surgery can sometimes stem its progression.

Ziwig is working on a second version of the test that will be able to specify the characteristics of the disease depending on the patient (superficial form of endometriosis, increased risk of infertility, etc.), in order to adjust treatments.

With AFP

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