NEJM Evidence has published a validation study for Ziwig Endotest, a saliva-based diagnostic test for endometriosis. The study reports results from a prospective, independent, multicenter clinical trial conducted across 17 public and private hospitals in France.
The study enrolled 971 symptomatic women aged 18 to 43 years. Ziwig Endotest was evaluated through analysis of 109 salivary microRNAs, combining next-generation sequencing with artificial intelligence. Diagnostic interpretations were performed blindly, without prior knowledge of patients’ clinical status.
The study reported sensitivity of 97.3%, specificity of 94.1%, overall accuracy of 96.6%, positive predictive value of 98.2%, and negative predictive value of 91.3%. Performance remained consistent across all subgroups, regardless of hormonal treatment, analgesic use, inclusion site, or sequencing conditions.
“This publication in NEJM Evidence is a major step forward for science and for women affected by endometriosis,” said Yahya El Mir, Founder and President of Ziwig. “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.”
Within the framework of France’s national early access program for breakthrough technologies (Forfait Innovation), Ziwig Endotest is now reimbursed and available on medical prescription in 100 hospitals across France. The test 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. Endometriosis affects around 10% of women of reproductive age, with diagnostic delays often exceeding seven years.
