ELISA-Based Test Uses Gynecologic Fluids to Detect Endometrial Cancer

Every year, 35 million postmenopausal women worldwide experience abnormal uterine bleeding (AUB), the primary trigger for initiating endometrial cancer diagnosis. Around 5% of these women will develop the disease, making early detection critical. Current diagnostics rely on analyzing biopsy samples, but 31% of cases fail due to low cellularity, requiring invasive hysteroscopies. A new test analyzing uterine fluid biomarkers now offers a safer, more accurate approach.

MiMark Diagnostics (Barcelona, Spain) is developing WomEC, an in-vitro diagnostic (IVD) immunoassay designed to detect endometrial cancer by quantifying protein biomarkers in uterine fluid. Unlike traditional methods, the test does not require cellular material and instead relies on a minimally invasive aspiration biopsy. By shifting focus from cells to proteins, WomEC provides a more reliable and accurate diagnostic pathway.

Image: The test analyzes biomarkers in uterine fluid to detect endometrial cancer (Photo courtesy of 123RF)

To identify the right biomarkers, MiMark analyzed nearly 1,000 uterine fluid samples in retrospective studies. Mass spectrometry revealed the proteomic landscape of uterine fluid and enabled the selection of novel proteins capable of distinguishing cancer patients from healthy individuals. These markers were adapted into an ELISA-based immunoassay, which is now undergoing final validation for clinical use.

The WomEC test will include a two-to-three-protein panel optimized for automated laboratory platforms. With a targeted sensitivity and negative predictive value of 97%, the test can safely rule out benign cases, sparing many women from unnecessary hysteroscopies. By reducing diagnostic timelines from one month to just two days, WomEC promises faster treatment decisions, lower risks, and improved patient management.

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MiMark Diagnostics