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Ziwig Endotest®: A Milestone in Endometriosis Diagnosis

The recent publication of the article titled "Validation of a Saliva microRNA Signature for Endometriosis" in NEJM Evidence marks a significant breakthrough in the field of women's health, specifically in the diagnostic approach to endometriosis. This advancement belongs to the developers at Ziwig, whose innovative saliva-based diagnostic test, the Ziwig Endotest®, has shown remarkable results through rigorous scientific validation.

Overview of the Clinical Study

The publication details the findings of a multicenter, prospective clinical study carried out in France, involving 971 symptomatic women between the ages of 18 and 43 years. This research was conducted in 17 different public and private hospitals, solidifying its standing on a broad platform and ensuring its relevance across diverse clinical settings.

One of the pivotal methods employed in the study involved the analysis of 109 salivary microRNAs. By utilizing next-generation sequencing (NGS) combined with advanced artificial intelligence techniques, the Ziwig Endotest® raised the bar for diagnostic accuracy. Notably, trial interpretations were performed in a blind manner, free of any prior knowledge regarding the patients' clinical conditions. This ensured a robust and independent methodology, an essential hallmark of scientific research.

Published Diagnosis Performance

The NEJM Evidence article highlights the impressive diagnostic performance of the Ziwig Endotest® with the following results:

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

These outstanding metrics reveal that over 96% of women assessed can expect a correct diagnosis utilizing the Ziwig Endotest®. Furthermore, this performance was consistently observed across various groups, regardless of factors such as hormonal treatment, analgesic use, inclusion site, or sequencing conditions, confirming that this test is reliable and reproducible in real-world scenarios.

Availability and Access

As part of France’s national early access program for breakthrough technologies, the Ziwig Endotest® is now eligible for medical prescription in 100 hospitals across the country. This initiative aims to provide quicker access to an accurate diagnosis for women aged 18 to 43 who suffer from chronic pelvic pain typically associated with endometriosis. Importantly, this test can now be prescribed outside of research settings, offering a non-invasive and efficient diagnostic method.

A Boon for Women’s Health

Endometriosis impacts approximately 10% of women in their reproductive years, a medical condition often shrouded in delays, with diagnostic times sometimes exceeding seven years. The validation and clinical rollout of Ziwig Endotest® signify a tremendous leap toward more timely, straightforward, and equitable diagnosis for women affected by this condition.

Yahya El Mir, the Founder and President of Ziwig, emphasized the importance of this milestone, stating, “This publication in NEJM Evidence is a major step forward for science and for women affected by endometriosis. We are deeply grateful to all the women, hospitals, and healthcare professionals whose commitment and support have been essential in bringing this innovation to patients.”

In conclusion, the Ziwig Endotest® stands as a testament to the possibilities that innovative technologies can offer in transforming healthcare, particularly in the diagnosis of conditions that have long been underserved. With endorsements from scientific authorities, this test paves the way for a healthier future for countless women, bringing relief and hope where it is most needed.

For further details, visit Ziwig website.