Endotest® Diagnostic will be available in Switzerland as from 1 June 2022
Endotest® Diagnostic will be available in Switzerland as from 1 June 2022
The Endotest® Diagnostic saliva test is a major innovation that provides a diagnosis of endometriosis within a few days with a reliability close to 100%.
It is CE marked and has applied for reimbursement to the health authorities in various countries, including France.
In parallel with this reimbursement procedure and to meet the expectations expressed by patients and professionals, it will be made available as a “non-reimbursed” product in most European countries, starting with Switzerland, where it will be available to patients from 1st June 2022.
Developed by the French start-up ZIWIG, Endotest® Diagnostic is a diagnostic test for endometriosis based on the exploration of human microRNAs present in saliva.
Endotest® Diagnostic uses two cutting-edge technologies: Next Generation Sequencing and artificial intelligence. Its reliability, close to 100%, is superior to that of all currently available diagnostic tools.
Endotest® Diagnostic detects all types of endometriosis, from superficial to deep forms. It clarifies d complex cases and dissociates endometriosis from other pathologies with a similar symptomatology.
It has been validated by a clinical study conducted in collaboration with 6 French endometriosis centres. The results of this study have been published in several peer-reviewed scientific journals1-5. In addition, the interim results of a second study, carried out in real life on 1000 patients suffering from pelvic pain, confirm the performance of reliability of Endotest® Diagnostic. This new study is currently being published.
In France, the National Strategy for the Fight against Endometriosis set up by the President of the Republic in February 2022 has made improving the detection of endometriosis one of its key issues. Women suffering from endometriosis are still subject to a long period of medical wandering (8 years on average) during which they undergo numerous appointments, analyses and medical imaging examinations before a diagnosis is made, in some cases requiring surgery.
The arrival of Endotest® Diagnostic puts a definitive end to this obstacle course and is fully in line with this strategy. From now on, women will only need to take a simple saliva sample and send it to the laboratory to find out, within a few days, whether or not they have endometriosis.
Endotest® Diagnostic is CE-marked, which allows go-to-market in all European countries. Applications for reimbursement have been submitted to the various competent national authorities to ensure the widest possible access to the test for women, including those in unfavorable socio-economic conditions.
Pending the outcome of these procedures, Endotest® Diagnostic will initially be made available to patients in all European countries without reimbursement by compulsory or public health insurance.
Switzerland will be the first country to give the possibility of obtaining the test to women and to their health professionals online from 1st June 2022 on the website of the medical analysis laboratory LABOR TEAM W AG (https://www.team-w.ch/fr) at a price of 781.20 CHF. This news is enthusiastically welcomed by the Swiss S-Endo Association, whose main aim is precisely to reduce the time taken to diagnose endometriosis.
In France, the inclusion of Endotest® Diagnostic in the healthcare system and its possible reimbursement are currently being evaluated by the competent national authorities. However, no timetable has yet been made public. More than 10,000 patients have registered on the Ziwig.com platform to be alerted as soon as the test becomes available.
The first boxes of Endotest® Diagnostic will be available in the coming months in many countries in Europe and around the world, offering access to a reliable, rapid, and non-invasive diagnosis of endometriosis. As a result, early treatment will be possible to improve the care and quality of life of patients.
1- 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
2 – 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
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 – 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
5 – Endometriosis Associated-miRNome Analysis of Blood Samples: A Prospective Study
Bendifallah S & al. Diagnostics. 2022; 12(5):1150.
https://doi.org/10.3390/diagnostics12051150
ABOUT ZIWIG
Ziwig is a company whose ambition is to improve women’s health through a holistic approach and the development of innovative and efficient diagnostic and prognostic tools.
This approach, constantly guided by the search for excellence, is based on the close collaboration of French medical experts and engineers specialized in cutting-edge technologies such as artificial intelligence and next-generation sequencing of human RNA.
It contributes to the emergence of precision, individualized, predictive, and participatory medicine, serving the well-being and quality of life of women.
Ziwig’s innovative technology is currently benefiting from an institutional support (notably by the French High Authority of Health) so that all women alluding endometriosis symptoms can benefit from it.
www.ziwig.com
Communication and press relations:
Marie-Hélène Coste, MHC – Finn Partners
marie-helene.coste@finnpartners.com
06 20 89 49 03
Véronique Simon-Cluzel, MHC – Finn Partners
veronique.simon-cluzel@finnpartners.com
06 68 86 32 30
