ZiwigEndo Test
A saliva test for the early and reliable
diagnosis of endometriosis
• Clear Positive/Negative results
• Early diagnosis
• All forms of endometriosis can be diagnosed
diagnosis of endometriosis
• Clear Positive/Negative results
• Early diagnosis
• All forms of endometriosis can be diagnosed
ZiwigEndo Test
A saliva test for the early and reliable
diagnosis of endometriosis
• Clear Positive/Negative results
• Early diagnosis
• All forms of endometriosis can be diagnosed
diagnosis of endometriosis
• Clear Positive/Negative results
• Early diagnosis
• All forms of endometriosis can be diagnosed
Ziwig Endo TestIntroduction
The average time for diagnosis in women is approximately 9 years1. During this time they might see any number of physicians and undergo numerous tests and examinations before a diagnosis, which sometimes requires surgery, is made.
New technology now allows women suffering from endometriosis to benefit from an early diagnosis. A French team of experts specialising in endometriosis has recently developed a saliva based diagnostic test that uses Next Generation Sequencing of microRNA’s with AI.
This non-invasive test, called Ziwig Endotest®, allows for the early detection of all types of endometriosis with a performance that exceeds that of conventional diagnostic tests2-6 (sensitivity 97.4% and specificity 93.7%4).
The Ziwig Endotest® is indicated for the diagnosis of endometriosis for female patients between the ages of 18 and 43 years who are clinically suspected to have endometriosis. The test must be requested by a doctor although the saliva sample collection can be carried out by the patient as a self-collect sample or under the supervision of her doctor or healthcare professional.
The Ziwig Endotest® has not been validated for use outside the age range of 18 – 43 years, and it is not validated for use by: 1)Pregnant patients, 2) Patients with a history of Cancer and/or with HIV. Patients need to declare that they are not unwell at the time of sample collection and that various precautions are taken to ensure that there is very low risk of saliva samples becoming contaminated.
The Ziwig Endotest® must be requested in accordance with the guidelines detailed in the instructions provided with the collection kit. Further studies are expected.
Ziwig Endotest® has been validated by one of the largest clinical trials6 for endometriosis in collaboration with 18 French specialist endometriosis centres. The diagnostic performance was initially tested from blood6, which later progressed to saliva samples4, providing clinicians with a reliable and rapid diagnostic test. Ziwig Endotest® has obtained the CE label.
A saliva test, why and when?
Compared to current methods Ziwig Endotest® represents a major innovation in the detection of endometriosis.8
Patient care will benefit greatly from the reduction in time to diagnose endometriosis, and this represents a major paradigm shift in clinical practice.2
The advantages of Ziwig Endotest®:
- Clear Positive/Negative results
- Early diagnosis
- All forms of endometriosis can be diagnosed2-6
- The Endotest Diagnostic has a sensitivity 97.4% and specificity 93.7% 4
- Non-invasive saliva sample
The Science
The development of a non-invasive test for the diagnosis of endometriosis has been the subject of intense medical research for many years. More than 100 biomarkers have been evaluated over the last decades. Among them, a new class of molecules first described in 1993, microRNAs, has emerged as a promising option, supported by a growing number of studies on tumours and neurodegenerative disorders.
MicroRNAs are small non-coding RNAs. They participate in gene expression: when a microRNA binds to its target, a specific messenger RNA, it blocks or stimulates its translation into protein and/or causes its destruction.
MicroRNAs are also released into the extracellular environment through different transport structures that protect them from ribonucleases present in the circulation and give them a remarkable stability. These circulating microRNAs are found in varying amounts in body fluids (blood, urine, breast milk, tears, saliva, etc.).
In recent years, there has been increasing evidence of the contribution of microRNAs in the pathophysiological mechanisms of endometriosis. A direct link has been proven between the dysregulation of certain microRNAs and the development of endometriosis lesions.10
References
- https://www.medscape.co.uk/viewarticle/average-endometriosis-diagnosis-delay-now-almost-9-years-2024a10004ax
- 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
- Validation of a Salivary miRNA Signature of Endometriosis – Interim Data. Bendifallah, Sofiane et al. JNEJM Evidence. 09 June. 2023, doi: 10.1056/EVIDoa2200282. https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200282
- 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
- International working group of AAGL ESGE ESHRE and WES, et al., 2021.
- Haute Autorité de Santé. Prise en charge de l’endométriose. Fiche de synthèse. Décembre 2017. https://www.has-sante.fr/upload/docs/application/pdf/2018-01/prise_en_charge_de_lendiometriose_-_demarche_diagnostique_et_traitement_medical_-_fiche_de_synthese.pdf
- https://www.eshre.eu/Guidelines-and-Legal/Guidelines/Endometriosis-guideline.aspx
- Panir K et al. Hum Reprod Update 2018;24(4):497-515.
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