#France #Lyon #Endometriosis #NEJM Evidence #Ziwig Endotest®

Ziwig Endotest®: A Breakthrough in Endometriosis Diagnosis

Endometriosis is a challenging condition that affects approximately 10% of women during their reproductive years. The diagnosis often takes more than seven years due to its complex symptoms and the inadequacies of traditional diagnostic methods, such as imaging. However, a revolutionary advancement has emerged with the introduction of the Ziwig Endotest®, a saliva-based diagnostic tool that has shown promising results in identifying this ailment through a non-invasive approach.

Recently, the prestigious journal NEJM Evidence, part of the New England Journal of Medicine Group, has published a significant article titled "Validation of a Saliva microRNA Signature for Endometriosis". This publication details a prospective, independent, multi-center clinical study conducted in France involving 971 symptomatic women aged between 18 and 43 years from 17 public and private hospitals.

The Study and Its Findings

The efficacy of the Ziwig Endotest® was evaluated through the analysis of 109 microRNAs in saliva, employing Next-Generation Sequencing (NGS) integrated with artificial intelligence. A major strength of this study was its blind assessment — the evaluators had no prior knowledge of the patients' clinical conditions. This methodological independence enhances the robustness of the findings, ensuring reliability across various patient demographics.

The results of the study highlighted extraordinary diagnostic performance:

• - Sensitivity: 97.3%
• - Specificity: 94.1%
• - Overall accuracy: 96.6%
• - Positive predictive value: 98.2%
• - Negative predictive value: 91.3%

These figures indicate that more than 96 out of 100 women could expect an accurate diagnosis when utilizing the Ziwig Endotest®. Furthermore, the diagnostic capability remained consistent across various subgroups, regardless of hormone treatments, pain medication use, clinical site, or sequencing conditions. This consistency emphasizes the test’s reliability and reproducibility in clinical practice.

Availability in Clinical Practice

The Ziwig Endotest® is not just a theoretical advancement; it is currently available for routine prescriptions within the French healthcare system. Thanks to the Forfait Innovation program, which facilitates early access to groundbreaking technologies, the test is now reimbursed and has already been introduced into 100 hospitals across France. This makes it accessible to women suffering from chronic pelvic pain suspected of being related to endometriosis, especially when imaging results are normal or inconclusive.

As a practical, quick, and non-invasive diagnostic option, the Ziwig Endotest® empowers women by providing a more straightforward pathway to diagnosis and, consequently, treatment.

A Leap Forward for Women’s Health

Yahya El Mir, the founder and president of Ziwig, stated, "This publication in NEJM Evidence marks a significant advancement for science and for women affected by endometriosis. We are deeply grateful to all the women, hospitals, and healthcare professionals whose dedication and support have made this innovation accessible to patients."

In conclusion, the validation and clinical use of the Ziwig Endotest® represent a substantial leap toward achieving earlier, simpler, and fairer diagnosis of endometriosis. As the iteration of this innovative tool unfolds, it holds the potential not only to transform diagnostic practices but also to improve the lives of countless women facing this challenging condition.

For more information, visit Ziwig's official website.