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Gnosis Unveils EdenDx: Transforming Women’s Health Diagnostics

In a groundbreaking development for women's health,
Gnosis, a diagnostic laboratory based in Southern California, has officially launched EdenDx. This innovative solution, short for Early Detection for Endometrial Neoplasia, marks the first commercially available non-invasive liquid-based cytology test designed specifically for early-stage endometrial cancer detection in the United States.

The Importance of Early Detection

Endometrial cancer ranks as the fourth most prevalent cancer among women in the U.S., with projections of over 69,000 new diagnoses anticipated in 2025 alone. Unfortunately, many of these cases are identified in later stages, often due to obstacles faced by women such as inconclusive imaging results, discomfort with standard biopsy procedures, and limited access to specialized healthcare.

Research indicates that nearly 30% of biopsies yield insufficient tissue, necessitating repeat procedures and causing delays in diagnosis. This demonstrates an urgent need for advancements in diagnostic technologies that can enhance early detection and reduce unnecessary procedures.

How EdenDx Works

EdenDx utilizes INEX's epiHERA™ technology, facilitating a more streamlined and efficient path to early cancer detection. The test involves collecting an endocervical sample during a standard pelvic examination using a simple cervical brush or broom, with the sample preserved in a ThinPrep® vial. The technology then identifies hypermethylation in two pivotal genes, CDO1 and CELF4, which have been strongly linked to endometrial cancer.

Results from EdenDx are typically available within 3 to 7 days, equipping healthcare providers with crucial data for assessing risk and making informed clinical decisions. Dr. Safedin Beqaj, the Clinical Laboratory Director at Gnosis, emphasizes that EdenDx aims to bridge the gap in women's healthcare, making early detection more accessible and effective without complicating routine care processes.

Targeting Underserved Populations

EdenDx was developed with a clear mission to support women historically underserved in gynecologic health diagnostics. The test is particularly beneficial for patients experiencing abnormal uterine bleeding, chronic anovulation, or those with postmenopausal symptoms. Additionally, women with elevated body mass index (BMI), a history of endometrial hyperplasia, or increased cancer risk due to Tamoxifen therapy or Lynch syndrome are prioritized in this innovative approach.

In the U.S., tens of millions of women fall within these high-risk categories, ranging from over 34 million women with elevated BMI to approximately 6 million diagnosed with polycystic ovary syndrome (PCOS). Despite these significant numbers, many women do not receive necessary evaluations until symptoms are severe.

Revolutionizing Gynecological Diagnostics

According to Dr. Beqaj, “EdenDx represents one of the most meaningful advances in gynecologic diagnostics in years. It provides healthcare providers with earlier and clearer insights using a process that is both familiar and comfortable for patients. This is the kind of patient-centered diagnostic innovation that we need.”

Validation studies have confirmed EdenDx's impressive performance, showcasing a specificity of 97.8% and a sensitivity of 85.3%, including for high-grade cancers. While it offers a significant reduction in unnecessary biopsies and enhances the efficiency of care, it is intended to complement traditional biopsy methods, which remain essential for definitive diagnosis.

Starting immediately, women's healthcare providers can integrate EdenDx into routine well-woman and pelvic exams. Gnosis remains dedicated to advancing diagnostics that align with real-world healthcare needs. EdenDx exemplifies this commitment by enhancing access to early detection through practical and scalable technology targeted at women who require it most.

For more information on obtaining EdenDx test kits or to explore partnership opportunities, visit www.gnosisdx.com or contact [email protected].

About Gnosis

Gnosis is a CLIA- and CAP-accredited diagnostic laboratory situated in Orange, California. It specializes in advanced testing for women's health, pharmacogenomics, and molecular diagnostics. Formerly known as Mountain View Medical Laboratory, Gnosis is a community-anchored lab dedicated to helping healthcare providers offer timely and effective care. Find out more at www.gnosisdx.com.

About INEX Innovate

Located in Singapore, INEX Innovate is leading the charge in molecular diagnostics focused on women's and fetal health. Recognized for pioneering proprietary technologies like epiHERA™ and OvaCis®, INEX Innovate continues to set high standards in diagnostic accuracy and accessibility. Visit www.inex.sg to learn more.