Gnosis, a diagnostic lab based in California that advances women’s health through molecular innovation, has launched EdenDx. EdenDx is the first commercially available and non-invasive liquid-based cytology test available in the US for early-stage endometrial cancer detection.
It is expected that 69,000 new endometrial cancer cases will be reported in the US in 2025. Despite its commonality, many women receive a late diagnosis and experience discomfort with biopsy procedures or limited access to specialty care. Scientific research shows that around 30% of biopsies result in insufficient tissue, which leads to repeat procedures and delayed diagnoses.
EdenDx, powered by INEX’s epiHERA technology, is a test that offers a simpler path to early detection of endometrial cancers. The test identifies hypermethylation of two genes, CDO1 and CELF4, which are strongly associated with endometrial cancer. The results are delivered within a week, helping providers assess risk and make timely, informed clinical decisions.
Validation studies showed that EdenDx achieved 97.8% specificity and 85.3% sensitivity, including in high-grade cancers. Although EdenDx can reduce unnecessary biopsies and improve care efficiency, it complements rather than replaces biopsies, which remain necessary for definitive diagnosis.
Dr. Safedin Beqaj, Clinical Laboratory Director at Gnosis, said: “EdenDx was designed to close a critical gap in women's health. We set out to make early detection more accessible by offering a molecular test that fits into routine care without adding complexity. This approach can help millions of women get timely answers and appropriate care without disrupting how providers deliver it.”
EdenDx was developed to help women who are often overlooked by traditional diagnostic approaches. The EdenDx test offers a non-invasive and accessible diagnostic option that enables earlier detection and improved outcomes for women who have been underserved in gynaecologic health.
