ENDOSURE's endometriosis diagnostic test receives CE mark for use across Europe
Positioned as first test that can be used by younger teens and postmenopausal women
A diagnostic test for endometriosis and adenomyosis has received CE marking, allowing it to be commercially deployed across the European Union.
The ENDOSURE Test, developed by US-based ENDOSURE Inc., is a non-invasive diagnostic designed to detect endometriosis in around 30 minutes.
The company says the test can be used across all stages of disease and age groups, including adolescents and postmenopausal women. Existing tests, such as Ziwig’s Endotest - which received the CE mark in 2022 - are currently indicated for those aged 18 to 43 years old.
“For the first time, a non-invasive test has been approved for use in adolescents, where the disease often begins,” said Dr. Mark Noar, co-founder and inventor of the ENDOSURE Test.
“This opens unprecedented opportunities for early suppressive therapy that could conceivably prevent progression to adult end-stage disease within 5 to 10 years.”
Endometriosis affects an estimated one in ten women globally and is associated with symptoms including chronic pelvic pain, heavy bleeding and infertility. Despite its prevalence, diagnosis remains a significant challenge, with delays often stretching for years due to reliance on imaging, clinical assessment and, in some cases, surgical confirmation. Laparoscopy is considered the gold standard for diagnosis, but as it requires surgical intervention, it is often avoided until symptoms become severe.
ENDOSURE could be used earlier in the care pathway as a first-line diagnostic, with potential to reduce delays and support ongoing disease management. The company also suggests the test could support ongoing disease management by helping clinicians assess treatment response and detect recurrence.
The CE mark follows approvals in a number of other markets, including the UK, Canada and parts of the Middle East, and enables the company to begin commercial rollout across Europe.
“This significant milestone opens access to one of the world’s largest healthcare markets,” added Carlos Babini, chief executive of ENDOSURE Inc.
“Long diagnostic delays for women are largely driven by limitations in current testing, including cost, access, accuracy, ease of use, and slow results.”
The company plans a rapid launch across the region, targeting healthcare providers and hospitals, though adoption will depend on clinical validation, reimbursement and integration into existing care pathways.
The development comes amid growing interest in non-invasive diagnostics for endometriosis, as companies seek to address one of the most persistent gaps in women’s health — early and accurate diagnosis of a condition that remains widely under-recognised and under-treated.