The High Authority of Health (HAS) has given the green light to granting an innovation package for the Endotest saliva test, which makes it possible to diagnose endometriosis.
- The Endotest saliva test, developed by the company Ziwig, is innovative, non-invasive and effective in diagnosing endometriosis, according to the HAS.
- Today, the health authority has decided in favor of exceptional financial support for the device, used in third line, as part of the innovation package.
- This will facilitate its access to patients suffering from chronic pain.
In France, endometriosis affects between 1.5 and 2.5 million women of childbearing age, or one in 10 people. In addition to being a source of chronic pain and infertility, patients suffering from this condition are faced with an almost systematic diagnostic delay, which is on average seven years, according to Health Insurance.
Endometriosis: the saliva test used in third line
To combat this medical wandering and facilitate patient care, Lyon biotech Ziwig has developed a saliva test, called Endotest, which makes it possible to diagnose this disabling gynecological pathology in a few days. The latter “comes in the form of a self-sampling kit, carried out at home by the woman concerned who then sends it to a laboratory via an envelope enclosed in the box. It makes it possible to characterize the expression of multiple biomarkers thanks to the carrying out high-throughput sequencing and the use of an algorithm designed by artificial intelligence”.
After recognizing the diagnostic effectiveness, the innovative and non-invasive nature of this test which covers a medical need which is not, the High Authority of Health (HAS) recommended that it be carried out in third line, more precisely after negative imaging examinations and persistence of pain despite appropriate medical treatment, but before laparoscopy. However, she said further research to assess its clinical utility in routine practice was needed. This is why the health authority suggested that the manufacturer of the Endotest submit a request to integrate it into an innovation package, rather than giving the green light for reimbursement under common law.
HAS authorizes the integration of Endotest into an innovation package
On October 18, 2024, HAS published a favorable opinion on the financial coverage of the saliva test as part of the innovation package. As a reminder, the innovation package is an exceptional and temporary support system, which helps to facilitate patients’ access to innovative technologies. “In practice, it allows an industrialist or a national professional council to obtain financial support for its technology from the implementation of the clinical study which will establish proof of its effectiveness. The innovation package is granted by the ministers responsible for Health and Social Security after advice from the HAS on the eligibility of the request, that is to say the innovative nature of the technology concerned and the relevance of the protocol of the proposed clinical study.can we read in the press release.
