Gnosis Launches EdenDx, the First Non-Invasive Liquid-Based Cytology U.S. Test for Early Endometrial Cancer Detection

ORANGE, Calif., July 30, 2025 /PRNewswire/ -- Gnosis, a Southern California-based diagnostic lab advancing women's health through molecular innovation, today announced the national launch of EdenDx, which stands for Early Detection for Endometrial Neoplasia, the first commercially available non-invasive liquid-based cytology test in the United States for early-stage endometrial cancer detection.

Endometrial cancer is the fourth most common cancer among women in the United States, 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, powered by INEX's epiHERA™ technology, is a liquid-based cytology test that offers a simpler path to early detection of endometrial cancer. An endocervical sample is collected during a routine pelvic exam using a cervical brush or broom and preserved in a ThinPrep® vial. The test identifies hypermethylation of two genes, CDO1 and CELF4, which are strongly associated with endometrial cancer.  Results are delivered within 3 to 7 days, helping providers assess risk and make timely, informed clinical decisions.

"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."

EdenDx was developed with a clear purpose: to serve women who are too often overlooked by conventional diagnostic approaches. 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 increased risk due to Tamoxifen therapy or Lynch syndrome.

Today, tens of millions of women fall into these high-risk categories. In the United States alone, over 34 million women live with elevated BMI, approximately 6 million are diagnosed with polycystic ovary syndrome (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," added Dr. 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.

Women's healthcare providers can begin offering EdenDx immediately. The test can be performed in conjunction with routine well-woman and pelvic exams.

Gnosis is committed to building diagnostics that fit real-world care. EdenDx reflects this mission by expanding access to early detection through technology that is practical, scalable, and designed for the women who need it most.

To request EdenDx kits or explore partnership opportunities, visit www.gnosisdx.com or contact [email protected].

About Gnosis

Gnosis is a CLIA- and CAP-accredited diagnostic lab based in Orange, California, specializing in advanced testing for women's health, pharmacogenomics, and molecular diagnostics. Formerly Mountain View Medical Laboratory, Gnosis is a community-anchored, innovation-driven lab helping providers make confident decisions and connect patients to timely, effective care. Learn more at www.gnosisdx.com.

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About INEX Innovate

Based in Singapore, INEX Innovate is a pioneering molecular diagnostics company focused on addressing unmet clinical needs in women's and fetal health. The company has developed proprietary diagnostic technologies such as epiHERA™ and OvaCis®, and is among the first in the region to introduce these tools to clinical practice. With a mission to drive innovation in healthcare, INEX continues to set new benchmarks in diagnostic accuracy, speed, and accessibility. Learn more at www.inex.sg.

SOURCE Gnosis