LYON, France, Dec. 2, 2025 -- NEJM Evidence, a journal of the New England Journal of Medicine Group, has published an article titled "Validation of a Saliva microRNA Signature for Endometriosis," dedicated to the saliva-based diagnostic test developed by Ziwig.
The publication reports the results of a prospective, independent, multicenter clinical study conducted in France. The study enrolled 971 symptomatic women aged 18 to 43 years across 17 public and private hospitals.
High-performance saliva-based diagnosis
The Ziwig Endotest® was evaluated through the analysis of 109 salivary microRNAs, combining next-generation sequencing (NGS) with artificial intelligence. Diagnostic interpretations were performed blindly, without prior knowledge of the patients' clinical status, ensuring full methodological independence and robustness.
The NEJM Evidence publication highlights exceptional diagnostic performance:
- Sensitivity: 97.3%
- Specificity: 94.1%
- Overall accuracy: 96.6%
- Positive predictive value: 98.2%
- Negative predictive value: 91.3%
These results show that more than 96 out of 100 women receive an accurate diagnostic result with Ziwig Endotest®. Performance remained consistent across all subgroups, regardless of hormonal treatment, analgesic use, inclusion site, or sequencing conditions, confirming the reliability and reproducibility of the test in real-world settings.
Now available for routine prescription in clinical practice
Within the framework of the French national early access program for breakthrough technologies (Forfait Innovation), Ziwig Endotest® is now reimbursed and available on medical prescription in 100 hospitals across France.
It is indicated for women aged 18 to 43 years with chronic pelvic pain suggestive of endometriosis, when imaging results are normal or inconclusive. The test can be prescribed outside any research study, providing women with rapid, non-invasive, and accurate access to diagnosis.
A major advance for women's health
Endometriosis affects around 10% of women of reproductive age, with diagnostic delays often exceeding seven years. The validation and clinical deployment of Ziwig Endotest® mark a major step forward toward earlier, simpler, and more equitable diagnosis.
"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," said Yahya El Mir, Founder and President of Ziwig.
For more information: www.ziwig.com
Contact presse – Finn Partners
Marie-Hélène Coste & Aurélia Adloff
06 20 89 49 03 / 06 89 38 94 70
sante@finnpartners.com
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