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

Ziwig Endotest®: A New Era in Endometriosis Diagnosis

In a remarkable development for women's health, Ziwig has announced the publication of a pivotal article in NEJM Evidence, a prestigious journal affiliated with the New England Journal of Medicine. The article, titled "Validation of a Salivary MicroRNA Signature for Endometriosis," highlights the successful utilization of the Ziwig Endotest®, a groundbreaking saliva-based diagnostic test for endometriosis. This innovative approach offers a much-needed solution for the 10% of women of reproductive age affected by this often painful condition, which is notoriously difficult to diagnose.

Clinical Study Overview

Conducted in France, the study was ambitious, involving 971 symptomatic women aged between 18 and 43 across 17 public and private hospitals. This independent, multicenter, prospective study aimed to assess the diagnostic accuracy of the Ziwig Endotest®, focusing on the analysis of 109 salivary microRNAs. With cutting-edge Next Generation Sequencing (NGS) technology and artificial intelligence employed during analysis, the tests were performed blind—meaning the professionals interpreting the results had no prior knowledge of the patients' clinical status—ensuring methodological independence and robustness.

Remarkable Diagnostic Performance

The results from the study were nothing short of extraordinary, showcasing a diagnostic performance that significantly outperforms many traditional diagnostic methods:

• - 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 every 100 women undergoing the Ziwig Endotest® can expect accurate diagnostic results. Notably, this high level of precision was consistent across various subgroups, irrespective of hormonal treatments, pain medication usage, or other factors, further affirming the test's reliability and reproducibility in real-world settings.

Availability and Impact on Women's Health

In a significant move towards improving women's healthcare, Ziwig Endotest® is now available for routine prescription in France as part of the national early access program for innovative technologies (Forfait Innovation). This means that, in 100 hospitals across the country, women aged 18 to 43 with chronic pelvic pain suggestive of endometriosis can receive this non-invasive and rapid diagnostic option, even if previous imaging tests have yielded normal or inconclusive results.

This new test marks a monumental step forward. Traditionally, delays in diagnosing endometriosis can extend beyond seven years. By validating and deploying the Ziwig Endotest®, healthcare providers can offer earlier, simpler, and fairer diagnostic solutions, significantly influencing the management of women's health issues.

Yahya El Mir, the founder and CEO of Ziwig, expressed heartfelt gratitude towards the hospitals and healthcare professionals whose support has been instrumental in bringing this innovation to patients. He emphasized the importance of this validation in NEJM Evidence as a crucial advancement for both science and women affected by endometriosis, declaring, “This represents a leap forward in ensuring timely and accurate diagnoses for women suffering from this condition.”

For more information about Ziwig and its pioneering developments in women's health, visit www.ziwig.com.