Test for early and reliable diagnosis of endometriosis

Ziwig Endotest® - World first saliva test for endometriosis

What is endometriosis?

Endometriosis is characterized by the presence of endometrial-like epithelium and/or stroma outside of the uterine cavity (womb). The growth of these tissue fragments is frequently associated with an inflammatory process1.

 

During menstruation, endometriosis lesions can react to variations in hormonal levels, leading to acute inflammation, bleeding, severe pain and many other symptoms. Endometriosis causes a significant deterioration in qualitý of life. Endometriosis affects about 10% of women of childbearing It potentially affects all women and can appear as early as from adolescence. Endometriosis can be completely asymptomatic and is sometimes diagnosed during a consultation prompted by difficulty in conceiving. In fact, a significant proportion of patients with endometriosis also suffer from infertility.

 

Symptoms of endometriosis

⚬  Severe menstrual pain

⚬  Pain during sexual intercourse

⚬  Pelvic pain outside of menstruation

⚬  Pain in the right shoulder

⚬  Digestive problems

⚬  Intense fatigue

⚬  Urinary disorders

⚬  Infertility

⚬  Pain during defecation

⚬  Painful rectal bleeding

⚬  Haematuria during menstruation

⚬  Alternating diarrhea – constipation

What is Ziwig Endotest®?

Ziwig Endotest® is a simple, non-invasive diagnostic test for early detection of all forms of endometriosis with a performance that exceeds that of conventional diagnostic tests2-6 (sensitivity >95%, specificity >95%, diagnostic accuracy AUC >95%9).

 

Ziwig Endotest®, a test based on Next Generation sequencing of microRNAs present in saliva was developed by a French company, Ziwig.

 

Ziwig Endotest® has been validated by one of the largest clinical trials ever carried out in this field in collaboration with 18 French centers specialized in endometriosis9. The Diagnostic performance was tested firstly on blood samples 6, and then on saliva samples4.

 

This tool is set to revolutionize the diagnosis of, and the care for, endometriosis by providing a reliable and rapid diagnosis to healthcare professionals who prescribe the test.

 

Ziwig Endotest® has obtained the CE label.

 

Ziwig Endotest®  is not intended to replace diagnosis by pelvic medical imaging. Medical imaging remains essential after diagnosis for lesion description, mapping, and classification.

Why and when to prescribe the salivary test?

Compared to current methods, Ziwig Endotest® represents a major innovation in the detection of endometriosis8.

 

Patient care will be greatly improved via the reduction of the average time to diagnosis from several years to a few weeks*7. Ziwig Endotest® paves the way for the early treatment of endometriosis and represents a major paradigm shift in clinical practice2.

 

* Current time from sampling to response: ~4 weeks

 

The advantages of Ziwig Endotest®:

⚬  Clear positive/negative result

⚬  Rapid diagnosis

⚬  All forms of endometriosis can be diagnosed 2-6

⚬  High reliability: close to 100% 9

⚬  Simple and non-invasive sample collection

 

The prescription of Ziwig Endotest® is recommended for women between 18 and 43 years of age, presenting one or more symptoms suggestive of endometriosis 4,8.

The science behind Ziwig Endotest®

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, microRNAs has emerged as a promising option. Humans have over 1,000 different microRNAs, which are small non-coding molecules with remarkable stability. Circulating microRNAs are found in varying amountś in body fluids (blood, urine, breast milk, tears, saliva, etc.). In recent years, new evidence has emerged regarding the contribution of microRNAs in pathophysiological mechanisms of endometriosis10.

How the test was developed

In summary, Ziwig had hundreds of women with symptoms of endometriosis submit both blood and saliva samples. All microRNA was quantified by sequencing. All women underwent conventional diagnostic testing. If no endometriosis could be found using imaging (ultrasound or MRI), laparoscopy was performed. This lead to a group with established endometriosis, and another group where no endometriosis could be found. A computer algorithm (AI) used the sequencing data to find similarities within the groups and differences between the groups. A signature based on sequencing data from 109 different microRNAs emerged. The performance on blood and saliva was similar, but the saliva sample was chosen in favor of simpler sampling and improved stability. This signature has since been tested in numerous clinical studies with sustained and proven performance.

Watch the opening of Ziwig Lab:

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København, Danmark

Klinik Hedegaard
Grønningen 15
1270 København

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Örebro, Örebro

Storgatans Gynekologiska Mottagning
Storgatan 12
703 61 Örebro

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Linköping, Östergötland

Vård Access
Sankt Larsgatan 22A
582 24 Linköping

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Stockholm, Stockholm

EndoGyn
Tre Kronors väg 45
131 31 Nacka

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Uppsala, Uppsala

CMedical Fertilitet
GynHälsan

Kålsängsgränd 10D
753 19 Uppsala

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Uppsala, Uppsala

CMedical Gynekologi
StudentGyn/GynHälsan

Rundelsgränd 3C
753 12 Uppsala

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Göteborg, Västra Götaland

GynRaMa
F O Petersons gata 6
421 31 Västra Frölunda

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Contact us if you are interested in offering Ziwig Endotest® to your patients. We collaborate with healthcare providers and clinics across the Nordic region.