Gnosis, a biotechnology company dedicated to developing diagnostic tests for a range of diseases, recently announced the launch of their first non-invasive test to diagnose early-stage endometrial cancer (EC), called EdenDx. Details about the launch were provided in a recent press release.
“We set out to make early detection more accessible by offering a molecular test that fits into routine care without adding complexity,” said Dr. Safedin Beqaj, Clinical Laboratory Director at Gnosis. “EdenDx represents one of the most meaningful advances in gynecologic diagnostics in years.”
The test requires an endocervical sample, which can be taken during a routine pelvic exam. Using a special laboratory technique, EdenDx can analyze samples for changes in the CDO1 and CELF4 genes that are often linked to EC. Results are typically provided within three to seven days.
EdenDx was developed with high-risk patients in mind, Gnosis said, including those with abnormal uterine bleeding, increased body mass index and Lynch syndrome. Millions of individuals in the United States alone fall into one or more of these high-risk categories, but many are not tested for EC until their disease reaches more advanced stages. Through this tool, Gnosis aims to create a paradigm shift that may change the way high-risk patients are diagnosed and treated.
Read more about EC testing and diagnosis
In studies to validate the efficacy of EdenDx, 85.3% of patients with EC were correctly diagnosed using the test. These findings suggest that EdenDx has the potential to enhance diagnosis and reduce the burden of unnecessary, invasive tests.
Now that EdenDx is commercially available, clinics can begin utilizing it immediately during pelvic examinations. Gnosis cautions that the test is not meant to completely replace endometrial biopsies, which are still required for a definitive diagnosis of EC.
The technology was developed in partnership with INEX Innovate, a Singapore-based company that develops diagnostic tools to improve women’s and fetal health.
Sign up here to get the latest news, perspectives, and information about EC sent directly to your inbox. Registration is free and only takes a minute.
