Reshaping
gynecological
diagnostics.
Who we are
At MiMARK we care for women’s health. We are developing innovative in vitro diagnostic solutions to improve the management of gynecological malignancies. We envision the gynecological fluid as the next step in liquid biopsy in gynecology. Our first objective is to improve Endometrial Cancer diagnosis.
Our approach for transforming
gynaecological care
The future of
Endometrial Cancer Diagnosis
Unmet clinical need
Abnormal vaginal bleeding affects 12M post-menopausal women in EU and US yearly. Diagnosis of endometrial cancer is mandatory since 10% of these women will suffer it. Current diagnosis is based on the pathological examination of an endometrial biopsy (pipelle biopsy), but this fails to diagnose 31% of patients, and provides an inaccurate diagnosis in 55% of cases. This failure is associated to the scarce cellularity of the sample. In those cases, invasive diagnosis using histeroscopy needs to be performed.
ENDOMETRIAL CANCER
4th
most common cancer
6th
most deathly cancer
IVD test based on a panel of 5 protein biomarkers present in uterine fluids to detect EC.
Our solution: WomEC
WomEC is an in-vitro diagnostic immunoassay for the detection of Endometrial Cancer (EC) based on the quantification of the expression level of proteins in the soluble fraction (no cellular material required) of a pipelle biopsy specimen. By using uterine fluid rather than cellular material for EC diagnosis, WomEC can provide a highly accurate diagnosis – with 99 percent sensitivity, 79 percent specificity, 97 percent negative predictive value and 87 percent positive predictive value – on all subjects undergoing the diagnostic procedure for EC. In addition, WomEC provides information regarding the tumor classification of EC to be used for treatment planning and surgical decision-making (pre-operative risk assessment).
WomEC is being developed as an immunoassay test to facilitate its implementation in clinical laboratories.
How will it impact the healthcare system
Accurate & objective diagnosis vs subjective pathology
Faster diagnosis & easy patient management from 1 month to 2-day diagnosis
Rule out benign patients safely, send home with no need of hysteroscopy (31% of cases)
Rule in high-risk EC patients to referral centers with optimal surgery plan
To PAYERS
More efficient patient management: reduced unnecessary procedures
Lower annual cost of care by avoiding hysteroscopies (average cost: USD 1,900 in US and 500€ in EU)
OUTCOMES | IMPACT |
---|---|
Two EU patents have been already accepted in several regions. | Well protected asset |
Five clinical retrospective studies involving more than 600 patients using mass spectrometry (LC-PRM) technology and ELISA assay |
Protein accuracy in clinical setting. |
International publications:
– Development of a sequential workflow based on LC-PRM for the verification of endometrial cancer protein biomarkers in uterine aspirate samples. Oncotarget 2016. |
|
Propietary antibodies developed | Prototype feasibility |
Validation of the clinical need +250 gynecologists and pathologists |
Clinical relevance |
Currently finishing the prototype development stage with proprietary antibodies |
Prototype development |
We seek partners to foster WomEC development,
validation and commercialization
Key Opinion Leaders are supporting WomEC
“WomEC will revolutionize uterine cancer diagnosis in the world”
Javier F. Magrina,
Director Gynecologic Oncology
“From a clinical perspective, the project is expected to benefit the European community”
Frederic Amant,
Head of the gynecology oncology department,
ex-chairman of the ENITEC consortium
Contact us
Investors:
Public Funding Sources:
Partners: