Saliva tests for endometriosis are to be reimbursed by the state healthcare system in France, but only for women who qualify, the health minister has said.
Reimbursement confirmation
On Monday February 10, Health Minister Catherine Vautrin announced that a new saliva test - which has been developed in France, but is still at the experimental stage - would be reimbursed from today (Tuesday, February 11) for certain patients.
Ms Vautrin has long said that she wants to make reimbursement for endometriosis testing and diagnosis easier. At the beginning of 2024, when she entered government, she made what she called “a personal commitment on the subject”.
Between two million and four million women in France of childbearing age are estimated to have the condition.
The cost of the new saliva test is €800 and will now be 100% covered by l’Assurance maladie for women who qualify in the first stage of the rollout, she said to France 2.
The tests are currently available in 80 hospitals nationwide.
Read also: Support for ‘promising’ new saliva test for endometriosis in France
Experimental test
Named ‘Endotest’, it has been designed by the Lyon-based biotech company Ziwig. It works by detecting the condition of endometriosis in saliva, through RNA analysis (a method for studying molecules in a biological sample) and sequencing. Results come back within a few days.
It has already “shown very good diagnostic performance” in initial evaluations, with a reliability of 95%, the founder and chairman of Ziwig, Yahya El Mir, has said. The test enables doctors “to get as close as possible to the biological functioning of cells and produce information that cannot be obtained through imaging or surgery, enabling a reliable biological diagnosis”, he added.
The tests pick up biomarkers of the disease, and aim to avoid the use of coelioscopy (inserting a tiny camera through the abdominal wall to examine the tissues underneath), as this is invasive and carries its own risks.
The Haute autorité de santé (HAS) has decided that existing studies on the test have been safe and successful enough to justify large-scale experimentation and rollout among the wider population, and in October 2024 it recommended Assurance maladie coverage of the tests for an initial rollout.
The government has followed and implemented the authority’s advice.
New study: 2,500 patients of 25,000
Around 25,000 patients over the age of 18 will now be eligible for the test in the coming months, estimate the Health Ministry and Ziwig.
Once the 2,500 women in the first rollout have had the test it will be extended to 22,500 more eligible women.
The first 2,500 patients reimbursed under the scheme will also be included in a clinical study, which will help to determine if state reimbursement for the test will be rolled out nationally in future.
The study will consider factors such as whether the saliva test leads to a reduction in the number of surgeries required for diagnosis, and whether it helps to improve treatment and healthcare outcomes.
“As soon as we have the results for these patients, the HAS will give a final opinion that [should] allow us to highlight the merits of the test and, subsequently, treatment for all women in our country,” said Ms Vautrin.
‘Major advance’
Céline Ferrara, director of operations at Endomind (an endometriosis patient association created in 2014), told FranceInfo that Ms Vautrin’s move was “a major advance for women's health”.
“It is now three years since the test was unveiled, and for three years we have been fighting to make this test available to patients with full reimbursement,” she said.
However, she added that “there is still a lot to be done” as “between one and two women in ten [between 2 and 4 million patients] suffer from endometriosis”.
She said that the trial has “great promise” and that a test “like this would allow early treatment”. However, she said that women have already “been waiting for things to progress for many years”, and called for the faster rollout of the test.
“It is obviously imperative that we move forward more quickly in this area,” she said.
What is endometriosis?
Endometriosis is a painful condition in which endometrial tissue - normally only found in the uterus - is found outside the uterus, such as in the ovaries, fallopian tubes, and even the bladder. It causes pain in the pelvis, and anywhere else that it is found.
Diagnosis can be difficult and take an average of seven years, the Health Ministry states. Diagnosis sometimes even requires surgery.
Read also: France formally recognises endometriosis as ‘long-term condition’
In some cases the condition can be debilitating and require further surgeries to fix. Some women experience major damage to internal organs such as their bladder and bowel, and the condition can also cause infertility as well as severely painful menstrual cycles, nausea, fatigue, digestive issues, painful sex, and pelvic bone pain.
“The symptoms have a considerable impact on the quality of life of those affected,” the Health Ministry has stated.
National strategy
In January 2022 President Macron announced the launch of a national strategy to combat endometriosis with a view to boosting understanding and awareness of the issue, as well as improving diagnosis rates and treatment plans.
Read more: President Macron launches French campaign against endometriosis
The president said that resources would be allocated to enable the country “to rise to the challenge” of fighting the illness, to “better understand it and its causes, and to find effective treatments”.
He said it was “time” to speak about it to “break the silence”, “time to act to make it easier to access care”, and “time to invest so that researchers can explore the causes of the illness” and create a national research programme, to bring together all the current resources.
“France can and must take the lead [in this research]. It is not only a problem for women, it is society’s problem,” he said.
