Revolutionizing
gynecological
diagnostics.

Who we are
In MiMARK we care for Women’s health. We are developing innovative in vitro tests to solve unmet clinical needs. WomEC is our first product in development: the future for endometrial cancer diagnosis.

Mimark
ongoing project

The next step for diagnosing
endometrial cancer


Unmet clinical need
Abnormal vaginal bleeding affects 11M 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 the assessment of 5 protein biomarkers in the uterine fluid
Solution
WomEC is an in vitro diagnostic test for EC detection based on the quantification of the expression level of a combination of five proteins in the soluble fraction (no cellular material required) of a pipelle biopsy specimen.
WomEC provides a highly accurate diagnosis (99% sensitivity, 79% specificity, 97% negative predictive value (NPV), and 87% positive predictive value (PPV)) on all subjects undergoing the diagnostic procedure for EC. In addition, WomEC provides information regarding tumor histology for those diagnosed with EC to be used in treatment planning and surgical decision making (pre-operative risk assessment).
WomEC is being developed as an immunoassay test to facilitate the clinical 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
Lower annual cost of care when avoiding hysteroscopies
More efficient patient management reduced unnecessary procedures

OUTCOMES | IMPACT |
---|---|
Two patents filled in 2016 and 2017, now extended in AU, BR, CA US, EU, JP, CH and now accepted in EU | Well protected asset |
Four clinical retrospective studies in 291 patients using mass spectrometry (LC-PRM) technology and ELISA assay |
Protein accuracy in clinical setting. |
International publications: – Oncotarget 2016, Clin Ca Research 2017, Expert Rev Proteomics. 2018 – Advances in endometrial cancer protein biomarkers for use in the clinic. 2017 – Targeted Proteomics Identifies Proteomic Signatures in Liquid Biopsies of the Endometrium to Diagnose Endometrial Cancer and Assist in the Prediction of the Optimal Surgical Treatment. 2017 – Development of a sequential workflow based on LC-PRM for the verification of endometrial cancer protein biomarkers in uterine aspirate samples. 2016 |
Credibility |
Antibody tests achieved in Research Use Only ELISA | Prototype feasibility |
Validation of the clinical need +150 gynecologists and pathologists | Clinical relevance |
Currently developing our own antibodies to develop the prototype assay | 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

Funding sources


Partners

