Gnosis recently launched EdenDx, the first commercially available, non-invasive, liquid-based cytology test in the U.S. for early-stage endometrial cancer detection. The test detects hypermethylation of two genes, CDO1 and CELF4, which are strongly associated with endometrial cancer. Until now, there have been no simple screening tests for endometrial cancer. To diagnose the disease, doctors mainly rely on symptoms, ultrasound, and biopsy. This new painless test delivers results within a few days.
Endometrial cancer is the fourth most common cancer among women in the U.S., with more than 69,000 new cases expected in 2025. Yet many diagnoses occur late, especially among women who face inconclusive imaging, discomfort with biopsy procedures, or limited access to specialty care. Research shows that nearly 30 percent of biopsies result in insufficient tissue, requiring repeat procedures and delaying diagnosis.
EdenDx, which stands for Early Detection for Endometrial Neoplasia, is a liquid-based cytology test that uses INEX’s epiHERA technology. An endocervical sample is collected during a routine pelvic exam using a cervical brush or broom and preserved in a ThinPrep vial. Results are delivered within three to seven days, helping providers assess risk and make timely, informed clinical decisions.
“EdenDx was designed to close a critical gap in women’s health,” said Safedin Beqaj, PhD, Clinical Laboratory Director at Gnosis. “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.”
The EdenDx test, developed by Gnosis, offers a non-invasive, accessible diagnostic option that enables earlier detection and better outcomes for women who have historically been underserved in gynecologic health. This includes patients with abnormal uterine bleeding, chronic anovulation, postmenopausal symptoms, elevated body mass index (BMI), a history of endometrial hyperplasia or polycystic ovary syndrome (PCOS), or increased risk due to Tamoxifen therapy or Lynch syndrome.
Today, tens of millions of women fall into these high-risk categories. In the U.S. alone, over 34 million women live with elevated BMI, approximately six million are diagnosed with PCOS, and many more face hereditary cancer risks. Globally, more than 200 million women are eligible for endometrial evaluation, yet most are not tested until symptoms become advanced.
“EdenDx represents one of the most meaningful advances in gynecologic diagnostics in years,” said Beqaj. “It gives providers earlier, clearer insight using a process that is familiar and comfortable for patients. This is what diagnostic innovation should look like—real-world, patient-centered, and ready to use.”
In validation studies, EdenDx demonstrated 97.8 percent specificity and 85.3 percent sensitivity, including in high-grade cancers. Compared to traditional methods, while EdenDx can reduce unnecessary biopsies and improve care efficiency, it is intended to complement but not replace biopsy, which remains necessary for definitive diagnosis.
The test is available immediately and can be performed in conjunction with routine well-woman and pelvic exams.
Formerly Mountain View Medical Laboratory, Gnosis is a CLIA- and CAP-accredited diagnostic lab based in Orange, California. The firm specializes in advanced testing for women’s health, pharmacogenomics, and molecular diagnostics.
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