The "Endotest" is already available in several other European countries, the biotech company behind it has said.
ADVERTISEMENTFrench health authorities will allow early access to a saliva test for endometriosis as part of an innovation scheme as it collects more data on the test's effectiveness.
The saliva diagnostic test, called "Endotest," was developed by the Lyon-based biotech company Ziwig.
The test looks for multiple biomarkers to diagnose endometriosis, which is a condition estimated to impact around 10 per cent of women and girls, or some 190 million people, according to the World Health Organization (WHO).
Endometriosis is characterised by intense pain during menstruation, sexual relations or when going to the bathroom as well as chronic pelvic pain, bloating, nausea, and fatigue, WHO says.
It is when tissue similar to the uterus lining grows outside the uterus.
Avoiding surgery for diagnosis
France's health regulator said that its decision to allow early access and exceptional reimbursement of the test was due to its "innovative nature and diagnostic effectiveness".
Currently, endometriosis is diagnosed based on a clinical exam and a pelvic ultrasound or MRI interpreted by a specialist, but this can be "inconclusive or negative" when legions are superficial, France's High Authority for Health (HAS) said.
In the event of intense pain, a laparoscopy or keyhole surgery can be performed to confirm the diagnosis - but this is an invasive procedure that presents certain risks.
The Endotest, meanwhile, had a good diagnostic performance, according to early data, and could "reduce the number of unnecessary laparoscopies carried out in" patients aged 18 or older suspected of having endometriosis, the HAS added.
It is meant only to be used after a clinical exam and ultrasound or MRI has been performed but could be given instead of the more invasive procedure.
However, its clinical usefulness has yet to be proven, and its high price tag and complex method make its wide use and long-term reimbursement "inappropriate," the regulator said.
'Major step forward'
Biotech company Ziwig says that its saliva test is a "major step forward to putting an end to the often long and painful" diagnosis process for endometriosis.
An interim analysis of the test's effectiveness was published in the New England Journal of Medicine in June 2023. The test uses next-generation sequencing and artificial intelligence (AI) to analyse saliva.
According to a June statement from the company, it is already available in more than 10 European countries.
Ziwig announced in December that it was launching a 34-month study involving 2,200 patients in 10 countries to develop a saliva test for multiple pathologies in gynaecology.
