Gnosis, a diagnostic lab located in Southern California that focuses on women’s health, has released EdenDx nationwide. EdenDx, which stands for Early Detection for Endometrial Neoplasia, is the first liquid-based cytology test in the United States that helps detect endometrial cancer without requiring an invasive procedure. This innovation is a significant step forward in women’s healthcare, especially for those who may face barriers in diagnosis due to unclear imaging, discomfort with biopsies, or limited access to specialist care.
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Endometrial cancer is the fourth most common cancer among women in the U.S., with around 69,000 new cases expected in 2025. However, many cases are detected in later stages because current diagnostic methods aren’t always reliable. Nearly 30 percent of biopsies fail to collect enough tissue, leading to repeated procedures and delayed diagnosis. EdenDx changes that by using a cervical brush or broom during a standard pelvic exam to collect a sample from the endocervix. The sample is stored in a ThinPrep vial and tested for hypermethylation in the genes CDO1 and CELF4, which are linked to endometrial cancer. Results are typically available within 3 to 7 days, allowing healthcare providers to make timely and informed decisions.
Dr. Safedin Beqaj, Clinical Laboratory Director at Gnosis, explained, “EdenDx was made to close a big gap in women’s health. We wanted to make early detection more accessible by offering a molecular test that fits into regular care without making things more complicated. This can help millions of women get answers and the right care, without changing how providers already work.” The test is particularly valuable for women often overlooked by conventional diagnostics, including those with abnormal bleeding, chronic anovulation, menopausal symptoms, elevated BMI, or increased risk from Tamoxifen therapy or a family history of conditions like Lynch syndrome.
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In the U.S., more than 34 million women live with high BMI, and nearly 6 million are diagnosed with polycystic ovary syndrome. Many more face hereditary risks for cancer. Globally, over 200 million women qualify for endometrial screening, yet most are not evaluated until symptoms become serious. EdenDx presents a more accessible alternative that can be included in routine gynecological care, helping reach more of these high-risk and underserved populations.
Dr. Beqaj added, “EdenDx is one of the biggest advances in gynecologic diagnostics in years. It gives doctors earlier, clearer information using a process that’s familiar and comfortable for patients. That’s what diagnostic innovation should be—real-world, patient-centered, and ready for use.” In validation studies, EdenDx demonstrated 97.8 percent specificity and 85.3 percent sensitivity, even in high-grade cancers. While not a replacement for biopsy, the test may help reduce unnecessary invasive procedures and improve care efficiency. Providers can begin offering EdenDx right away during routine well-woman and pelvic exams, supporting Gnosis’s goal of creating diagnostics that work in everyday clinical practice and expanding access to early cancer detection for the women who need it most.
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