An innovative device but in an early phase
Endotest® is a non-invasive medical biology test, based on a saliva sample. It measures the expression of 109 microRNA biomarkers using high-throughput sequencing and a predictive algorithm. This test is intended for patients with symptoms suggestive of endometriosis, such as chronic pelvic pain, but with normal or equivocal imaging findings. Currently in the early phase of distribution, the Endotest® is available under medical prescription as part of the innovation package. This mechanism allows early reimbursement for patients presenting symptoms of endometriosis when imaging tests are inconclusive.
The test will be reserved for women aged 18 to 43 and can only be prescribed by a gynecologist working in one of the 80 participating health establishments designated by the Ministry of Health for this initiative, thus facilitating access to this new medical technology.
The test represents a notable technological advance by relying on artificial intelligence to analyze microRNA biomarkers. Although it has not yet been widely integrated into medical practice, it could be a game-changer by making the diagnosis of endometriosis faster and less invasive, in particular by reducing the use of laparoscopy.
A response to an uncovered medical need
Endometriosis is often difficult to diagnose, with the only diagnostic alternative being laparoscopy, an invasive surgical procedure. Endotest® could fill this need by reducing the need for laparoscopy, particularly for minimal lesions. However, although innovative, the test does not yet provide sufficient expected service according to the preliminary clinical studies available. These do not yet assess the clinical usefulness for patients, but indicate a potential significant clinical benefit.
An ambitious study project to validate its usefulness
In order to meet the expectations of the HAS and validate the clinical interest of the Endotest®, a non-randomized comparative study project was proposed by the Ziwig company. The study will include 2,500 patients and will evaluate the impact of the test on medical decision-making and patients’ quality of life. The feasibility of this study seems reasonable, with 80 centers spread across the national territory and inclusion over a period of 12 months.
The press release of October 18, 2024 specifies that the Endotest® also obtained a innovation packagethus facilitating early access to the test for certain patients. This temporary support is a strong signal to encourage evaluation of the device in real conditions while guaranteeing patient safety. THE innovation package allows us to respond to urgent needs while collecting the necessary data for possible generalization.
Easy access for patients
The HAS gave a favorable opinion to the exceptional coverage of the Endotest®, while requesting adjustments to the study protocol before considering a request for reimbursement under common law. The granting of innovation package in October 2024 reinforces the interest of this innovative device, thus accelerating its access for patients while allowing the collection of clinical data. This saliva test could play a key role in reducing invasive diagnostics for endometriosis.
