Non-Invasive Liquid-Based Cytology Test Enables Early Endometrial Cancer Detection

Endometrial cancer is the fourth most common cancer among women in the United States, with over 69,000 new cases expected in 2025. Yet many diagnoses occur late, particularly in women who face inconclusive imaging results, discomfort with invasive biopsy procedures, or limited access to specialized care. Nearly 30 percent of biopsies result in insufficient tissue, often requiring repeat procedures that delay timely diagnosis. This diagnostic gap is even more pronounced in women with abnormal uterine bleeding, chronic anovulation, postmenopausal symptoms, elevated body mass index (BMI), a history of endometrial hyperplasia, or increased cancer risk due to Tamoxifen therapy or Lynch syndrome. With over 34 million women in the U.S. living with elevated BMI, 6 million diagnosed with PCOS, and millions more globally facing hereditary risks, the demand for improved diagnostic options is critical. Now, a non-invasive solution aims to support earlier and more accessible endometrial cancer detection for high-risk women.

Gnosis (Orange, CA, USA) has developed EdenDx (Early Detection for Endometrial Neoplasia), a non-invasive liquid-based cytology test for early-stage endometrial cancer detection. Powered by the proprietary epiHERA technology from INEX Innovate (Singapore), EdenDx collects endocervical samples using a cervical brush or broom during routine pelvic exams and preserves them in a ThinPrep vial. The test analyzes the hypermethylation of two genes, CDO1 and CELF4, which are strongly linked to endometrial cancer. Designed to integrate seamlessly into existing clinical workflows, EdenDx delivers results within 3 to 7 days, helping healthcare providers assess risk and make timely, informed decisions. The test aims to fill a critical diagnostic gap in gynecologic care by offering an accessible and patient-friendly method that complements traditional biopsy procedures without introducing complexity.

In validation studies, EdenDx demonstrated a specificity of 97.8% and a sensitivity of 85.3%, including in cases of high-grade cancers. While not intended to replace biopsy, EdenDx can reduce the number of unnecessary biopsies and improve care efficiency. It is now available for use during routine well-woman and pelvic exams. The test is designed to serve women who have historically been underserved by conventional diagnostic tools, offering a scalable, real-world solution that aligns with the mission of expanding access to early detection technologies. Gnosis is actively partnering with providers to make EdenDx widely available and impactful across diverse healthcare settings.

“EdenDx represents one of the most meaningful advances in gynecologic diagnostics in years. It gives providers earlier, clearer insight using a process that is familiar and comfortable for patients,” said Dr. Safedin Beqaj, Clinical Laboratory Director at Gnosis. “This is what diagnostic innovation should look like—real-world, patient-centered, and ready to use."

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