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Ziwig Endotest®

A major innovation to reduce time to diagnosis!

What is Ziwig Endotest® ?

Ziwig Endotest® is an in vitro diagnostic device for use by healthcare professionals only for the diagnosis of endometriosis from a saliva sample.

Ziwig Endotest® is an innovative, non invasive, diagnostic tool based on the analysis of salivary miRNAs via NGS (Next Generation Sequencing) and by Artificial Intelligence (AI).

Ziwig Endotest® is intended for patients between the age of 18 and 43 years with symptoms suggestive of endometriosis1 **:

  • Chronic pelvic pain
  • +/- dysmenorrhea
  • +/- deep dyspareunia
  • +/- dysuria/painful urination
  • +/- dyschezia/painful defecation
  • +/- painful rectal bleeding or haematuria during menstruation
  • +/- pain in the shoulder tip
  • +/- infertility

1. The reasons for, or situations in, which someone would use the diagnostic tool

  • Patients with suggestive symptoms of endometriosis and when imaging examination results are normal or equivocal, before empirical medical treatment.
  • Patients with persistent suggestive symptoms of endometriosis despite medical treatment and when imaging examination results are normal or equivocal.

2. Exclusion Case

  • Endometrioma or rectosigmoid endometriosis found on US and/or MRI examination.

Ziwig Endotest® is a prescriptive-use only device, and saliva collection must be done under the supervision of a healthcare professional.

Limitations regarding the population**

  • The patient must be at least 18 and no more than 43 years of age at the time of testing.
  • The patient must not have a history of cancer or Human Immunodeficiency Virus (HIV) infection.
  • The patient must not be pregnant at the time of testing.
  • Ziwig Endotest® is intended for female patients only.
  • Ziwig Endotest® can be performed under hormonal treatment.
  • Ziwig Endotest® can be performed at any time of the cycle.

Interpretation of results

Three types of results are possible for Ziwig Endotest®:

  • A positive result from the Ziwig Endotest® is in favor of the
    presence of endometriosis in the patient. A positive result cannot completely confirm the presence of endometriosis.
  • A negative result from the Ziwig Endotest® is in favor of the absence of endometriosis in the patient. A negative result does not completely rule out the presence of endometriosis.
  • An invalid result: the sample and/or the sequencing file could not be analyzed or is not interpretable.

Medical management of the patient must be based on all available clinical and biological data.

Possibly allows to put an end to the diagnostic errancy (reducing the average time to diagnosis from 8 years to a few days) but also to improve the overall care2 of endometriosis by:

  • Opening the way to early treatment of endometriosis

  • Allowing to slow down or even stop the aggravation of pain and other symptoms

  • Optimizing the care of infertility

  • Limiting the deterioration of patients’ quality of life

Reliable and fast.

Ziwig Endotest® is the possibility of having, within a few days and with a reliability close to 100% (sensitivity >95%, specificity >95%, diagnostic accuracy (AUC) of >95%)2, a diagnosis.

Simple to use
but based on cutting edge technology.

Ziwig Endotest® requires a simple saliva sample. The diagnosis is made in the laboratory. It relies on Next-generation Sequencing of micro RNA present in saliva and on the use of artificial intelligence to process the very large volume of data generated.

A unique technology
accessible at every point in the territory.

No matter how close or far away you are from a specialised centre, Ziwig Endotest® gives you access to a simple, easy and fast diagnosis with the same levels of quality and safety.

Shorten wandering and restore hope!

Women affected by endometriosis endure an average of 8 years4 of diagnostic errancy and see approximately 10 doctors5 before being diagnosed.

Conceived for all cases of endometriosis, including the most complex.

Ziwig Endotest® makes it possible to confirm or eliminate the diagnosis of endometriosis with a high reliability and to distinguish endometriosis from other pathologies with a similar sympthomatology3,6-10. It is particularly indicated in complex cases when medical imaging remains uncertain.

A large clinical study
conducted in collaboration with 18 partner sites. 

A study involving 1000 patients to evaluate the value of miRNAs for the diagnosis of endometriosis.

Learn more

« Ziwig Endotest® is a breakthrough in the diagnosis of millions of women worldwide. It will avoid many surgical interventions and will allow the early implementation of treatments that will change their daily lives. In addition, this test will help to put a name to a very disabling symptomatology and will contribute to hastening the recognition of this chronic disease in society, in working life and in education. »

Pr Sofiane Bendifallah
Director of the Expert Centre for Endometriosis and the Clinical Research Group of Sorbonne University (GRC 6 C3E)

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In partnership with
the patient association Endomind.

”"The arrival of Ziwig Endotest® is a radical change for all women who suffer from pelvic pain. Getting a reliable diagnosis in a few days with a simple saliva sample is a real revolution for them and their medical care."

Nathalie ClaryEx-President of the association Endomind

A premium
solution.

Ziwig Endotest® is performed with CE rated in-vitro diagnostic medical devices (kit and Endotest® Diagnostic).

Ziwig applies the ISO 13485 standard for quality management systems.

We respect the RGPD obligations and the recommendations of the e-health charter recommended by the Ministry of Health.

Learn more

Ziwig Endotest® is an in vitro diagnostic device reserved exclusively for professional use for the diagnosis of endometriosis on salivary samples.
Ziwig Endotest® is an innovative diagnostic method based on the analysis of salivary miRNAs and the identification of phenotypic profiles characteristic of endometriosis identified by NGS (Next Generation Sequencing) method and modeled by AI.
Read carefully the information provided with Ziwig Endotest®. Manufacturer: Ziwig. Update: 04/2023.
For Ziwig partner laboratories using Ziwig AccessPoint, the leaflet is available here. Password can be requested by writing to service@ziwig.com.
* Omnigene Oral is an in vitro diagnostic device for the collection and stabilisation of nucleic acids in saliva. Manufacturer of the Omnigene Oral collection IVDD: DNA Genotek Inc. Read the enclosed leaflet carefully. Update : 10/2023.
** IFUED100v02

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

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