First Non-Invasive Endometrial Cancer Detection Test, EdenDx, Launched by Gnosis

Gnosis has announced the launch of EdenDx, the first non-invasive, liquid-based cytology test for early endometrial cancer detection. Using cervical samples, it detects hypermethylation of the CDO1 and CELF4 genes, with results available in 3–7 days. In validation studies, EdenDx demonstrated 97.8% specificity and 85.3% sensitivity, offering a scalable and patient-friendly diagnostic option.

EdenDx does not require invasive sampling; instead, it uses an endocervical specimen collected during a standard pelvic exam—typically with a cervical brush or broom—and preserved in a ThinPrep® vial. Gnosis then analyzes the sample for hypermethylation of two genes, CDO1 and CELF4, which are strongly associated with endometrial malignancy. Results are typically available within 3 to 7 days, enabling providers to triage patients more effectively and initiate timely care.

"EdenDx was designed to close a critical gap in women's health," said Dr. Safedin Beqaj, 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.”

Clinical Validation and Use

In validation studies, EdenDx showed 97.8% specificity and 85.3% sensitivity, including in high-grade cancers. While it is not a substitute for biopsy—which remains the standard for definitive diagnosis—it has the potential to reduce unnecessary invasive procedures, particularly in low-risk patients with inconclusive symptoms.

Endometrial cancer is the fourth most common cancer in women, but many at-risk individuals remain undiagnosed until late stages due to barriers like inconclusive imaging, biopsy limitations, or lack of access to care. With over 34 million U.S. women living with obesity, 6 million with PCOS, and many more at hereditary risk, proactive evaluation remains critically underutilized worldwide.

Addressing an Underserved Population

The implications are far-reaching. Many women at heightened risk for endometrial cancer remain undiagnosed until symptoms become advanced, especially those with chronic anovulation, abnormal uterine bleeding, obesity, postmenopausal status, or a family history linked to Lynch syndrome or Tamoxifen therapy.

"EdenDx represents one of the most meaningful advances in gynecologic diagnostics in years," added Dr. Beqaj. “It gives providers earlier, clearer insight using a process that is familiar and comfortable for patients.”