A comparative study on the clinical usefulness of a Polish non-invasive test for the early diagnosis of endometriosis has been given a positive opinion by the Bioethics Committee of the Poznan University of Medical Sciences, the Medical Research Agency reports.
Until recently, the only reliable method of confirming endometriosis was collecting material during laparoscopic surgery. The EndoRNA test, the Medical Research Agency's own project, is a quick, safe procedure that can be performed in a doctor's office. It involves taking a fragment of the uterine mucosa (endometrial biopsy) during a gynaecological examination.
The sample is sent to a laboratory where the activity of the FUT4 gene is checked. The result may be available within 48 hours, most often within 7-15 days. This means that the diagnosis of endometriosis may take between a few days and two weeks, and not 6-8 years, as is the case today.
The shortened diagnostic time is crucial for patients because it allows them to start treatment earlier and minimize the negative effects of endometriosis, such as infertility, severe pain and suffering. According to the Medical Research Agency experts, the EndoRNA test may be crucial in identifying cases that would previously remain undiagnosed.
The EndoRNA test has been commercially available in Poland since 2023.
In the clinical trial, scientists led by Professor Ewa Wender-Ożegowska will assess its effectiveness and sensitivity in the early diagnosis of endometriosis compared to the laparoscopic method.
Specialists hope that the positive results of the comparative study will open the way to reimbursement of the test, which may significantly increase the availability of early endometriosis diagnosis for millions of Polish women.
Endometriosis is characterized by the presence of cells in the lining of the uterine body (endometrium) outside the uterine cavity. These cells are still secretively active and, responding to hormonal changes occurring during the menstrual cycle, cause a chronic inflammatory reaction in the body.
According to statistics, 6-10 percent of women aged 15-49 may suffer from this condition. In Poland this is approximately 3 million women, and in the world - approximately 200 million. However, not all cases of the disease are diagnosed.
Endometriosis causes severe pain that excludes women from normal functioning and professional activity. It is also responsible for approximately 40 percent cases of female infertility, and among patients with endometriosis, as many as 50 percent have fertility problems. (PAP)
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