2024-04-04 09:14:13
A simple saliva test can now detect endometriosis within days. Anticipating an increase in demand, its founder invested in a laboratory and state-of-the-art robots, capable of analyzing several thousand samples each week, near Dax, in the southwest.
Built in a few months, this “Ziwig Lab”, located in Tercis-les-Bains, a small town in Landes, is now operational.
Tests detecting endometriosis through saliva using RNA analysis and sequencing (“Endotest”) were designed by Lyon-based biotech Ziwig.
In January, the High Authority for Health (HAS), based on several studies, reported a diagnostic accuracy of 95% for a device that it deemed “promising” and “innovative”.
A “clear recognition” for Yahya El Mir, the founder and president of Ziwig.
Its test is based on the analysis of microRNAs (miRNAs), a new class of biomarkers that play an important role in gene expression.
– Shorten wandering –
Among more than 2,600 human microRNAs detected to date, nearly a hundred were identified by Ziwig as being involved in endometriosis and present in saliva.
A chronic disease affecting around one in ten women, endometriosis usually results in severe pain during periods and/or fertility problems.
Even today, it is diagnosed, often by chance, with an average delay of seven years.
Thanks to its “simple and reliable” saliva test, Ziwig hopes to revolutionize the care of affected women.
For Claire Théodore, gynecological surgeon, who will open consultations in the health center adjoining the laboratory, “the test will change a lot of things”, in particular by making it possible to “considerably shorten diagnostic wandering”.
At the end of March, the Minister of Health, Catherine Vautrin, indicated that the government was awaiting the results of the latest HAS studies in June before deciding to reimburse the test, which costs around 1,000 euros, “by the end of the ‘year”.
– “Routine” –
Anticipating strong demand internationally but also in France, Ziwig invested in the Landes laboratory to provide itself with the means for a rapid response from this industrial site.
“While until now, only around a hundred tests per week were carried out manually, we will be able to analyze 4,500 to 9,000 in the new lab,” explains Hikmat Chahine.
In a space of 120 m2, different stages are entirely robotic.
From pipettes containing patients’ saliva, two microliters of fluid are extracted, the equivalent of a single drop. The machines mix reagents there, before the “sequencing” stage which uses the properties of light to precisely measure the quantity of micro-RNA molecules.
Thanks to artificial intelligence which makes possible the rapid analysis of the very large volume of data generated by high-throughput sequencing, the test can state with almost certainty, in a few days, whether or not the patient is affected by endometriosis.
Initially, the tests are intended to be prescribed following imaging (ultrasound or MRI) in adult patients, with the aim of avoiding laparoscopy, an invasive surgery.
“Ultimately, I imagine that this will become a routine diagnostic tool” in cases of suspected endometriosis, anticipates Yahya El Mir.
But the company does not want to limit itself to this disease. It has already launched studies to diagnose, through the analysis and sequencing of salivary RNA, other gynecological pathologies (ovarian cysts, fibroids, etc.), cancers (uterus, ovary) and even breast cancer. Charcot.
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