Endometriosis, responsible for chronic pain and infertility, affects approximately 10% of women of childbearing age. Although this pathology has a significant impact on quality of life, it remains poorly understood, with diagnosis sometimes difficult. However, a start-up based in Lyon has just developed a new diagnostic test which could revolutionize the treatment of this disease.
How is endometriosis usually diagnosed?
First intentions
As a first approach, the diagnosis of endometriosis is mainly based on a clinical examination. The clinical diagnosis is then based on the symptoms and observations resulting from the physical examination (mainly the gynecological examination). However, it is important to note that a normal clinical examination is not sufficient to exclude the presence of endometriosis.
Secondly, the diagnosis is established using an imaging assessment including a pelvic ultrasound and a pelvic MRI, carried out or interpreted by a specialist. When lesions are superficial or minimal, imaging results may be inconclusive or negative.
Laparoscopy
Laparoscopy can also be considered to confirm the diagnosis of endometriosis , especially when intense pelvic pain persists despite well-conducted treatment (analgesics, oral contraceptives, ovarian suppressants) or in the event of a desire to become pregnant.
However, as a surgical procedure, laparoscopy is invasive, involves risks and is not considered a curative method. Sometimes, this intervention even turns out to be unnecessary, especially when no lesion characteristic of the disease is detected.
A sometimes long diagnosis
The diagnosis of endometriosis is often a long and complex journey. In fact, it takes on average 7 years to achieve confirmation. This prolonged duration is attributable to various factors , including the lack of awareness among health professionals regarding the detection and management of this pathology. In addition, the variability of symptoms, the lack of knowledge among medical teams and patients, the stigmatization of gynecological symptoms, as well as the societal normalization of pain in women, also contribute to delaying diagnosis.
Unfortunately, this gap leads to therapeutic wandering that is detrimental to affected women , leading to silent and sometimes irreversible progression of the disease. Faced with this worrying reality, the search for solutions to facilitate the detection of endometriosis appears to be a necessity.
Endotest, the new diagnostic test
Endotest is a medical device for diagnosing endometriosis, using a saliva sample . Its operation is based on high-throughput sequencing of microRNAs present in saliva, with the use of artificial intelligence to analyze the vast set of data generated.
Potential interests
Endotest offers significant potential benefits in the complex context of endometriosis diagnosis. As a non-invasive alternative, this test is of major interest: in the event of a negative result, it avoids unnecessary laparoscopies and directs instead towards the exploration of other pathologies, thus promoting appropriate care. This approach would make it possible to respond to a medical need that has not been met until now.
Furthermore, Endotest could prove particularly useful in patients aged 18 and over, of childbearing age, presenting symptoms highly suspicious of endometriosis and pelvic pain not controlled by empirical medical treatments, or in those expressing a desire of pregnancy.
Promisingly, the company marketing Endotest also claims that this process could significantly reduce diagnostic times , thus offering the prospect of ending the therapeutic wandering often associated with endometriosis.
Opinion of the High Authority of Health
On January 8, 2024, the High Authority of Health (HAS) issued its evaluation report on the Endotest saliva test, thus providing an essential resource for a better understanding and appropriation of this innovation.
Regarding effectiveness
The HAS evaluation revealed a notable diagnostic performance of this test (with a sensitivity of 95% and a specificity of 94%), thus highlighting the high expectations and the significant potential of this test in the patient management strategy. .
However, despite these promising results, the clinical utility of Endotest remains to be demonstrated. The data provided by the manufacturer do not make it possible to establish with certainty the positive impact of the test on patient care. Furthermore, the available information does not make it possible to precisely determine the population benefiting from this test. Therefore, widespread deployment could lead to inappropriate use of this test, which is often perceived as "quick and simple", but is in reality complex and expensive to use. It is also important to note that Endotest does not, however, fall into the category of rapid diagnostic orientation tests (TROD).
Regarding reimbursement
The HAS recognizes the innovation and potential of the Endotest diagnostic test, but insists on the need to carry out additional studies to assess its clinical usefulness in current practice. Thus, to facilitate patients' access to this innovative technology, it first offers early and secure access via the innovation package , a temporary exceptional support system. Indeed, although permanent reimbursement of Endotest cannot be confirmed at this stage, it is likely to meet the criteria for the innovation package.
Some patients could therefore benefit from early access under certain conditions, while awaiting the results of the study on clinical utility. This study would provide crucial information, such as the impact of the test on patient care, the potential volume of prescriptions in the target population and acceptability by patients. These data are essential to meet the expectations of patients and healthcare professionals regarding the practical use of Endotest. They will allow, within a reasonable time, a decision to be taken on the permanent reimbursement of Endotest.
Endometriosis, a disease significantly affecting the lives of women, could see an improvement in its management thanks to the innovative diagnostic test Endotest. This test would indeed have many potential advantages, including avoiding unnecessary procedures. However, despite the encouraging performance revealed by the HAS, the clinical usefulness of Endotest remains to be proven, requiring additional studies. And while early access via the Innovation Package is an encouraging opportunity, permanent reimbursement will depend on the future results of these essential studies.
References :
High Authority of Health. (January 8, 2024). Complex diagnosis of endometriosis: HAS offers access to the Endotest saliva test as part of the innovation package.
Ziwig . Ziwig Endotest.
Allaire C, Bedaiwy MA, Yong PJ. (June 19, 2023). Diagnosis and therapeutic management of endometriosis.
Ministry of Health and Prevention. (August 21, 2019). What is endometriosis?
