If you are a private lab dealing with high rates of inconclusive biopsy results—where 31% of women fail to receive a diagnosis—this project developed an IVD test that uses protein biomarkers to provide a 97% negative predictive value.
Non-invasive Liquid Biopsy Test for Accurate Endometrial Cancer Diagnosis
Imagine trying to find a needle in a haystack, but the needle is a tiny piece of tissue that often disappears during a biopsy. This technology stops looking for the tissue and instead looks for five specific protein 'fingerprints' left behind in the fluid. It's like detecting a scent instead of needing to catch the animal, making the process much gentler and more reliable for the patient.
What needed solving
Endometrial cancer diagnosis is currently invasive and inefficient, with 31% of biopsies failing to provide a diagnosis due to insufficient material. This leads to costly, invasive follow-up procedures and delayed treatment.
What was built
An IVD test and immunoassay prototype that uses a proprietary algorithm and antibodies to detect 5 protein biomarkers in uterine fluid.
Who needs this
Who can put this to work
If you are a hospital system dealing with high costs and patient trauma from invasive hysteroscopies, this project developed a liquid biopsy tool that reduces the need for invasive follow-up procedures through a 99% sensitivity rate.
If you are a manufacturer dealing with a lack of non-invasive gynecological cancer tools, this project developed a verified immunoassay prototype and proprietary algorithm that can be integrated into diagnostic product lines.
Quick answers
What is the cost or price of the WomEC test?
Based on available project data, the specific price per test is not disclosed, but the project aims to reduce overall healthcare costs by minimizing unnecessary invasive procedures.
How is the technology scaled for industrial use?
The project is developing an in vitro diagnostic (IVD) tool targeted at clinical laboratories within public and private hospital systems.
What is the IP and licensing status?
The technology is protected by two patents and the project has recently increased IP protection for its biomarkers and key reagents.
What regulatory standards are being followed?
The project has implemented and is maintaining a Quality Management System (QMS) to meet regulatory requirements for IVD tools.
What is the timeline for market availability?
A verified immunoassay prototype was expected by January 2023, with clinical validation and commercialization targeted for 2024.
Who built it
The project is led by a single Spanish SME, Mimark Diagnostics SL. With a 100% industry ratio and no university or research partners, the project is lean and commercially driven, focusing heavily on IP protection and QMS implementation rather than academic exploration.
Contact Mimark Diagnostics SL regarding the WomEC IVD prototype
Talk to the team behind this work.
Contact us to explore licensing opportunities for the WomEC biomarker panel.