ZIWIG Endotest Endometriosis Saliva Test

ZIWIG Endotest® is a new non-invasive diagnostic saliva test which can be done at home anywhere in the UK for reliable and rapid diagnosis for all types of endometriosis

About 10% of all women are affected by endometriosis with average times for diagnosis of around 8 years. Patients not infrequently see up to 10 doctors before being diagnosed with endometriosis (MRI, pelvic ultrasound, laparoscopy). Ziwig Endotest® is able to detect all types of endometriosis, mild and advanced.

This DIY home saliva test relies on Next Generation Sequencing of micro RNA present in saliva and on the use of Artificial Intelligence to analyse the results. Ziwig Endotest® is an in vitro diagnostic test for diagnosis of endometriosis on salivary samples with reliability close to 100% and at a significantly reduced cost compared to laparoscopy. Results are available in 4 weeks.

Endometriosis, Pain and Infertility.

Endometriosis affects 10% of women of childbearing age in France, being 1.5 to 2.5 million women. It potentially concerns all menstruating women and can appear as early as adolescence.

This disease is characterized by the presence of endometrium (mucous membranes lining the inside of the uterus) outside the uterine cavity, in various organs: ovaries, vagina, rectum, bladder, intestines, lungs… At the time of menstruation, these endometrial fragments found in abnormal locations cannot be removed (1).

The disease can also be completely asymptomatic. In this case, it is usually discovered by chance during a consultation motivated by difficulties to conceive a child. UA significant proportion of patients with endometriosis also suffer from infertility.

Three forms of endometriosis are classically described: superficial or peritoneal endometriosis, ovarian endometriosis and deep endometriosis. There is no systematic correlation between the symptoms and the severity of the disease (1).

Worsening of symptoms over time

In about one third of cases (especially in superficial forms), endometriosis can stagnate or even regress, either with treatment or on a spontaneous way. But more often, the symptoms, including pain, get worse over time.

The persistence of pain favors the phenomenon of hypersensitivity: the pain perception level decreases, resulting in the evolution of the pain towards chronicity. .

This chronic pain can appear at any stage of endometriosis and persist even after the lesions of endometriosis are no longer visible (2,3).

Hypersensitivity is favored by the remanence of pain over time and in turn reinforces the evolution of the pain towards chronicity.

Treatment

Today, there is no treatment that can cure endometriosis. Beyond the analgesic treatment adapted to each patient, hormonal treatments, which are based on the use of estrogen-progestin contraceptives or continuous progestins, aim to block the occurrence of periods. This background treatment prevents recurrence and the development of new lesions. These treatments can also call upon, in second intention, drugs (Gn-RH agonists, anti-androgens) which put the patient in a state of transitory menopause. These treatments may lead to hot flashes, mood disordes, weight gain…, but an add-back therapy (pill given at the same time) most often avoids these side effects (4).

Surgical treatment is considered when medical treatments are insufficient to relieve the pain. Its goal is to remove endometriosis lesions and correct anatomical abnormalities caused by the disease, including adhesions that reduce organ mobility. The procedure is most often performed by laparoscopy (4).

A major impact on personal and social life

Endometriosis is the cause of a significant deterioration in quality of life.. The pain is responsible for sleep disorders which induce chronic fatigue and psychological disorders (irritability, depression…), causing deterioration in family and social relationships. This in turn leads to a deterioration in family and social relationships. Sexuality is altered, often with major repercussions on the couple. Infertility and uncertainties related to the MAP process also have an important impact (1).

Average annual cost of endometriosis is € 9579 per woman, with an average of 33 days of sick leave per year. The overall societal cost of the disease is estimated at 10.6 billion euros in France (5,6).

The need of a non-invasive diagnostic test

The laparoscopy is now considered as the reference examination for the diagnosis of endometriosis (8). It is nevertheless an invasive procedure that must be performed under general anesthesia and may, like any surgical procedure, be accompanied by intra- or post-operative complications.

The development of a non-invasive diagnostic test for endometriosis has therefore been a major medical need for many years. More than a hundred potential biomarkers (angiogenesis factors, growth factors, hormonal, immune and inflammatory markers, etc.) have been evaluated over the past decades (8).

Among these biomarkers, a new class of molecules discovered in 2000, microRNAs, has emerged as a promising option, supported by a growing number of evidence from studies on cancer and degenerative disorders (9,10).

References

  1. https://www.endomind.eu/wp-content/uploads/2019/02/Reflexions_sur_lendiometriose_en_france.pdf ;

  2. https://www.who.int/fr/news-room/fact-sheets/detail/endometriosis ;

  3. https://www.endofrance.org/wp-content/uploads/2020/07/Hypersensibilisation_Endofrance-SPloteau.pdf ;

  4. 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 ;

  5. Kanj O. Evaluation économique de la prise en charge de l’endométriose. https://tel.archives-ouvertes.fr/tel-02080162v2/document ;

  6. Fourquet J et al. Fertil Steril 2010; 93(7): 2424–2428. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2860000/pdf/nihms147074.pdf ;

  7. Kiesel L et al. Climacteric 2019;22(3):296-302.

  8. Nisenblat V et al. Cochrane Database Syst Rev 2016;2016 (5):CD012179. ;

  9. Baulande S et al Medsci 2014; 30 : 289-296 ;

  10. Agrawal S et al.Int J Mol Sci 2018;19(2):599

EXCLUSIONS

The test is only available for women 18-43 years old who do not have cancer, are not pregnant or are HIV positive.

Learn More

Ziwig Endotest Sample Taking Instructions January 2023

Ziwig_Endotest_Patient_Booklet_Feb 2023