What Is Ziwig Endotest®?
Ziwig Endotest® is a simple, non-invasive diagnostic test for early detection of all forms of endometriosis with a performance that exceeds that of conventional diagnostic tests2-6
- Sensitivity of 97%
- Specificity of 100%
- Diagnostic accuracy (AUC) of 98%4
Ziwig Endotest ®, a test based on Next Generation sequencing of microRNAs present in saliva was developed by a French company, Ziwig.
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Endometriosis is characterized by the presence of endometrial-like epithelium and/or stroma outside of the uterine cavity (womb). The growth of these tissue fragments is frequently associated with an inflammatory process1.
During menstruation, endometriosis lesions can react to variations in hormonal levels, leading to acute inflammation, bleeding, severe pain and many other symptoms. Endometriosis causes a significant deterioration in quality of life.
Endometriosis affects about 10% of women of childbearing age. It potentially affects all women and can appear as early as from adolescence. Endometriosis can be completely asymptomatic and is sometimes diagnosed during a consultation prompted by difficulty in conceiving. In fact, a significant proportion of patients with endometriosis also suffer from infertility.
Ziwig Endotest® has been validated by one of the largest clinical trials ever carried out in this field6 in collaboration with 15 French centers specialized in endometriosis. The Diagnostic performance was tested firstly on blood samples6, and then on saliva samples4.
This tool is set to revolutionize the diagnosis of, and the care for, endometriosis by providing a reliable and rapid diagnosis to healthcare professionals who prescribe the test.
Ziwig Endotest® has obtained the CE label.
Compared to current methods, Ziwig Endotest® represents a major innovation in the detection of endometriosis7.
Patient care will be greatly improved via the reduction of the average time to diagnosis from several years to a few days8. Ziwig Endotest® paves the way for the early treatment of endometriosis and represents a major paradigm shift in clinical practice.2
The advantages of Ziwig Endotest®:
- Clear Positive/negative result
- Rapid diagnosis
- All forms of endometriosis can be diagnose2-6
- Simple and non-invasive sample collection
High reliability
- Close to 100% reliability
- Sensitivity of 97%
- Specificity of 100%
- Diagnostic accuracy (AUC) of 98%4
The prescription of Ziwig Endotest® is recommended for women between 18 and 43 years of age, presenting one or more symptoms suggestive of endometriosis4,7
Ziwig Endotest® is not intended to replace diagnosis by pelvic medical imaging. Medical imaging remains essential after diagnosis for lesion description, mapping, and classification.
- International working group of AAGL ESGE ESHRE and WES, et al., 2021
- Machine learning algorithms as new screening approach for patients with endometriosis. Bendifallah S & al. Sci Rep. 2022 Jan 12;12(1):639. doi: 10.1038/s41598-021-04637-2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8755739/pdf/41598_2021_Article_4637.pdf
- Clues for Improving the Pathophysiology Knowledge for Endometriosis Using Serum Micro-RNA Expression. Dabi Y & al. Diagnostics (Basel). 2022 Jan 12;12(1):175. doi: 10.3390/diagnostics12010175. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8774370/pdf/diagnostics-12-00175.pdf
- Salivary MicroRNA Signature for Diagnosis of Endometriosis. Bendifallah & al. J Clin Med. 2022 Jan 26;11(3):612. doi: 10.3390/jcm11030612. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8836532/pdf/jcm-11-00612.pdf
- MicroRNome analysis generates a blood-based signature for endometriosis. Bendifallah S & al. Sci Rep. 2022 Mar 8;12(1):4051. doi: 10.1038/s41598-022-07771-7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8902281/pdf/41598_2022_Article_7771.pdf
- Endometriosis Associated-miRNome Analysis of Blood Samples: A Prospective Study Bendifallah S & al. Diagnostics. 2022; 12(5):1150. https://doi.org/10.3390/diagnostics12051150
- https://www.eshre.eu/Guidelines-and-Legal/Guidelines/Endometriosis-guideline.asp
- https://solidarites-sante.gouv.fr/soins-et-maladies/prises-en-charge-specialisees/endometriose