Biological diagnosis of endometriosis in just a few days.
Ziwig Endotest®
What is Ziwig Endotest®?
Ziwig Endotest® is an in vitro diagnostic
medical device used on medical prescription for the diagnosis of endometriosis using a saliva sample.
Ziwig Endotest® is designed for patients aged 18 to 43 with symptoms indicative of endometriosis1 ** :
- Chronic pelvic pain
- +/- dysmenorrhoea
- +/- profound dyspareunia
- +/- dysuria/painful urination
- +/- painful dyschezia/defecation
- +/- painful rectal bleeding or haematuria during menstruation
- +/- Pain at the point of the shoulder
- +/- infertility
1. Reasons or situations in which a person would use Ziwig Endotest® ** :
- according to the IVDR CE mark: patients with symptoms suggestive of endometriosis;
- Ziwig Endotest® can be performed under hormonal treatment;
- Ziwig Endotest® can be performed at any time during the menstrual cycle.
2. Contraindications to the use of Ziwig Endotest® ** :
- pregnancy in progress;
- medical history of cancer or HIV;
- infection at the time of saliva collection;
- Poor sampling conditions the presence of endogenous substances (such as blood or nasopharyngeal secretions) or exogenous residues (food, toothpaste, lipstick, tobacco, chewing gum)
Ziwig Endotest® is a device used on medical prescription.
Ziwig Endotest®
finally a reliable, non-invasive biological test for diagnosing endometriosis
1st use of salivary microRNA1-6 in gynaecology
Reliable and fast
With Ziwig Endotest® a diagnosis can be made in just a few days with near-perfect accuracy (97.4% sensitivity, 93.7% specificity)2.
Simple to use
but based on cutting-edge technology.
Ziwig Endotest® requires a simple saliva sample. Diagnosis is carried out in the laboratory. It is based on high-throughput sequencing of the microRNA present in saliva and the use of artificial intelligence to process the very large volume of data generated.
A technology
accessible anywhere in the country.
Whether you are near or far from a specialist centre, Ziwig Endotest® gives you access to a simple, easy and fast diagnosis with the same levels of quality and safety.
Designed for all cases of endometriosis,
including the most complex.
Ziwig Endotest® makes it possible to confirm or rule out the diagnosis of endometriosis with a high degree of reliability and to distinguish endometriosis from other pathologies with a similar symptomatology3,6-10. It is particularly indicated in complex cases where medical imaging remains uncertain.
An extensive clinical study
conducted in collaboration with 18 partner sites.
A study of 1,000 patients to assess the value of miRNAs for diagnosing Ziwig Endotest®.
« Ziwig Endotest® represents a breakthrough in the diagnosis of millions of women throughout the world. It will avoid numerous surgical interventions and will enable early initiation of treatment that will change their daily lives. In addition, this test will help to put a definite name to a very debilitating symptomatology and contribute to hastening the recognition of this chronic disease in society, in the workplace and in education. »
Ziwig Endotest® is produced using CE-marked in-vitro diagnostic medical devices (kit and Endotest® Diagnostic).
Ziwig applies the ISO 13485 quality management system standard.
We comply with the General Data Protection Regulation or RGPD (EU Regulation 2016/679), the French Data Protection Act (Loi Informatique et Libertés n°78-17 modifiée or LIL), and the applicable provisions of the Public Health Code.
* Omnigene Oral is an in vitro diagnostic device for the collection and stabilisation of nucleic acids in saliva. Manufacturer of Omnigene Oral collection IVDD: DNA Genotek Inc. Read the enclosed leaflet carefully. Updated: 09/2024
Ziwig Endotest® is an in vitro diagnostic device for professional use in the diagnosis of endometriosis using a saliva sample.
Ziwig Endotest® is an innovative diagnostic method based on the analysis of salivary miRNA and the identification of phenotypic profiles characteristic of endometriosis identified by NGS (next generation sequencing) and modelled by AI.
This in vitro diagnostic medical device is a regulated health product and bears the CE mark.
Please read the information supplied with Ziwig Endotest® carefully. Manufacturer: Ziwig. Update : 09/2024
Ziwig Endotest® has been CE certified by a notified body (2797).
** Access to IFUs :
- Ziwig Endotest® IFU for Sequencing Laboratories (FR, EN)
- Ziwig Endotest® IFU for Distributor Laboratories (FR, EN, HU)
- Ziwig AccessPoint IFU (FR, EN)
Passwords for accessing the IFUs are available by contacting the following address: service@ziwig.com
1 – https://www.eshre.eu/Guidelines-and-Legal/Guidelines/Endometriosis-guideline. aspx
2 – Bendifallah, Sofiane et al. “Validation of a Salivary miRNA Signature of Endometriosis — Interim Data” NEJM Evidence. 09 June. 2023. doi: 10.1056/EVIDoa2200282
3 – 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
4 – https://solidarites-sante.gouv.fr/soins-et-maladies/prises-en-charge-specialisees/endometriose
5 – Omar Kanj. Evaluation économique de la prise en charge de l’endométriose. Economies et finances. Université Clermont Auvergne, 2017. Français.
6 – 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
7 – 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
8 – 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
9 – Endometriosis Associated-miRNome Analysis of Blood Samples:A Prospective Study Bendifallah S & al. Diagnostics. 2022; 12(5):1150. https://doi.org/10.3390/diagnostics12051150
10 – A Bioinformatics Approach to MicroRNA-Sequencing Analysis Based on Human Saliva Samples of Patients with Endometriosis. Bendifallah S & al. Int. J. Mol. 2022, 23, 8045.
https://doi.org/10.3390/ijms23148045
Stay connected
Sign up to be notified of the latest news and publications.
