The future of Endometrial Cancer diagnosis.
GyLDEC:
redefining endometrial cancer diagnosis.
GyLDEC is an IVD Immunoassay to aid in the detection of Endometrial cancer. The test is intended to be used in post-menopausal women with abnormal uterine bleeding that are referred for an endometrial biopsy.
GyLDEC is based on a panel of protein biomarkers associated with endometrial cancer, that measured in uterine fluids obtained from pipelle biopsies, provides an accurate detection of endometrial cancer.
This minimally invasive test provides quick, objective, and precise data to aid in the endometrial cancer diagnostic pathway. Specifically, the test is built to achieve conclusive results in the patient first consultancy with the highest level of assurance. Overall, the product improves diagnostic accuracy, decreases the need of invasive tests, and helps optimize clinical workflows while lowering overall diagnostic costs.
Why it matters
Abnormal uterine bleeding (AUB) in postmenopausal women is the primary trigger for endometrial cancer evaluation and affects an estimated 4–11% of women, corresponding to approximately 35 million women worldwide.
Despite the high prevalence of this condition, current diagnostic pathways rely on invasive and uncomfortable procedures. GyLDEC addresses this unmet need by delivering a diagnostic test that is simple, reliable, and patient-centered, without compromising scientific rigor.
Clinical Validation and Status
Developed in collaboration with Vall Hebron Institute of Research. Validated through multi-center studies and peer-review publications. Compatible with existing IVD platforms.
Ready for global scale-up through strategic partnerships.
- Strong scientific background and peer review publications.
- MiMARK has built a solid IP position with four patent families covering the intended use, key reagents, and proprietary biomarkers, with protection in key jurisdictions.
- Developed in collaboration with Vall Hebron Institute of Research.
- Validated in a national and multicentric-investigational study (WomEC SEGO — clinicaltrials.gov ref. NCT06192017)
- Ready for clinical international validation and global scale-up.