Műtét nélküli endometriózis diagnózis Magyarországon

BREAKING NEWS! Diagnosis of endometriosis without surgery

As a science communicator, it's incredibly important to me that the Endoblog community gets the world's news as quickly as possible, from a credible and accurate source, in a way that they can understand.

I first reported in April on this French company's new product, the EndoTest, which can confirm or exclude the presence of endometriosis with a certainty of 100%, based on a simple saliva test, without surgery.

Now in France, I interviewed the professor who represents them, asking him about the research, the results, but most importantly, whether they plan to make the test available in Hungary, following other European countries, and if so, when, and how it will be received by laparoscopic surgeons.

It was an incredibly exciting discussion! As you may be used to, the first thing we did For EndoMails I'm sending the article to them, and I've even got a little extra surprise for them in addition to the public interview. Join us!

Interview with Professeur Sofiane Bendifallah (MD, PhD)

Nóra Árvai: What exactly is the purpose of Ziwig, what is Endotest® and how does it work?

Sofiane Bendifallah: Ziwig is a start-up company dedicated to improving women's health through a holistic approach and the development of innovative and effective diagnostic and prognostic tools. This approach is based on close collaboration between medical experts and engineers specialised in cutting-edge technologies such as artificial intelligence and next generation sequencing of human RNA.

The Ziwig Endotest® is a non-invasive diagnostic tool that provides a quick diagnosis for people with endometriosis from a simple saliva sample.

The Ziwig Endotest® uses two cutting-edge technologies, next-generation sequencing and artificial intelligence, to evaluate the entire human microRNA pool (approximately 2600 microRNAs) for endometriosis from a simple saliva sample.It can detect all types of endometriosis, from superficial to deeply infiltrated forms.

Á.N.:. How was the test done? What research has been done? How long did it take to develop the method? How many women were involved in the studies? Is this number enough to say with confidence that the diagnosis is reliable?

S.B.: Personally, I have been working on miRNA projects for 8 years, mainly researching cancer biomarkers. We built on my experience when we teamed up to create EndoTest. We reviewed the literature because we know that microRNA plays an important role in biological processes (such as differentiation, proliferation and cell death, or metastasis) and in the pathophysiology of many diseases (type 2 diabetes, cancer, cardiovascular diseases, etc.).

In recent years, there has been increasing evidence supporting the role of miRNAs in the cellular mechanisms of endometriosis. A direct link has been established between the deregulation of certain miRNAs and the development of endometriosis lesions.

We performed the Endo-miRNA study, the largest prospective study of microRNAs in endometriosis in terms of number of patients and number of samples.

A total of 1000 patients with pelvic pain and dysmenorrhoea were studied. The results of the interim study, based on the results of the first 200 patients, confirm the accuracy and reliability of the procedure.

The results of the interim study have been submitted for publication and should be available in the near future. The results of the 1000 patient study, although expected to be similar to existing results, will have to wait a little longer until they are available in 2023.

Á.N.:What were the main findings of your research?

S.B.:Our research has produced a number of evidence-based findings and our work has been published in 8 peer-reviewed journal articles this year, including:

A study demonstrating the added value of artificial intelligence in analysing complex data on endometriosis,
Study on the value of RNA, and in particular microRNA, as relevant biomarkers of endometriosis,
Investigation of human microRNAs and their significance as biomarkers of physiopathological processes involved in endometriosis,
A study showing the value of saliva compared to blood in non-invasive diagnostics

Our initial study involved 200 women and a further validation study involving 1000 patients is now in its final phase.

Interim analysis based on the first 200 patients from a population of 1000 patients confirms the accuracy of the saliva signature and its external multicentre validation (manuscript submission pending).

The use of artificial intelligence allows the analysis of huge amounts of data (in fact, for each sample, we have identified the entire known human microRNA pool - over 2600 microRNAs!).

The results of the 1000 patient study will be available in 2023.

Á.N.: What do the French health authorities say about the Ziwig Endotest®?

S.B.:Ziwig's innovative technology has so far received very positive feedback from the French Public Health Authority, and the reimbursement of the Ziwig Endotest® is currently under discussion.

Á.N.: When will Ziwig Endotest® be available in more countries? How will patients get access to Ziwig Endotest®?

S.B.: In Europe, the Ziwig Endotest® is CE-approved, which allows it to enter the market in all European countries.In some countries it is already available. For example, it was launched in Switzerland in September, in Germany in October and in Austria in November. Ziwig Endotest® will be launched in ten more countries by the end of December 2022.

The Ziwig Endotest® will be available to patients through their doctor, as it is a prescription-only medical test.

Á.N. :How do surgeons react to the Ziwig Endotest®?

S.B.:We have presented our scientific data to experts around the world since the beginning of 2022 and the feedback has been incredibly positive.
Surgeons support the Ziwig Endotest® because it offers 3 major advantages:

Reduces diagnostic delays.
The test is non-invasive and provides a clear diagnosis for all women aged between 18 and 43 who suffer from dysmenorrhoea.
The test will allow surgeons to focus on what is important - treating patients with therapeutic surgery rather than purely diagnostic surgery.

If the test helps to reduce the number of diagnostic laparoscopies, it will be a big step forward for all women with endometriosis who do not yet have a clear diagnosis.

Á.N.:. Will the Ziwig Endotest® be available in Hungary?

S.B.:Discussions are ongoing and we expect to have a partnership for distribution in Hungary by the end of this year. We aim to make the Endotest diagnostic available to patients in Hungary in the first months of 2023.

Á.N.. How much does the Ziwig Endotest® cost?

S.B.:The technology and processing costs result in a price of between 800-1000 Euros. Applications for reimbursement (i.e. TB-financed solution) have been submitted to the various competent national authorities. It is up to them to ensure the widest possible access to testing for women, including those living in disadvantaged socio-economic circumstances.

Thank you for the interview:

Professeur Sofiane BENDIFALLAH (MD, PhD)-ot

Service de Gynécologie Obstétrique Médecine de la Reproduction

Hôpital TENON

APHP, Sorbonne Université

And now let's see what all this means:

EndoBlog SpecialReview

As a science communicator and health psychologist who has been working with people with endometriosis for 13 years, I talk to you a lot about how to read research and interpret it critically. Over the last 13 years I have read countless studies on this topic, some of which I have brought to your attention to draw your attention to possible pitfalls, to wrong conclusions, and some of which I have not even shown you because I did not want to take your time, because the house of cards seemed to be falling. If anybody, I can see where the slips are, where the wrong conclusions are, because I think I've gone a bit overboard with this critical approach.:-D

But now I'm definitely hopeful, it's a very exciting direction. Although we must remember that they are only based on the results of the first 200 patients, which is not a large number, I am confident that the results will be as consistent as the company representative was confident in saying.

It is also very encouraging that Germany, who are the strictest in this respect, have allowed the test to be used.

So I don't want to shout anything, but the fact is that I have never been so optimistic. Of course, as soon as the other results are available, I will bring them to you, first of all For EndoMails, and then publicly.

Please remember that EndoBlog and my work in science communication, research, translation, interviewing, traveling, my work with my beloved patients and my EndoStop SisterHood I do it mostly at night.It's now after three in the morning. If there is a typo in this article, please forgive me and support my work by sharing it, it means a lot.

Thank you!

Nóra Árvai

health and sexual psychologist, perinatal counsellor, specialist writer, science communication specialist, expert in the field of EndoStop Sisterhood creator and mentor