A new test for endometriosis has the potential to replace surgical diagnosis, data has shown.
The US women’s health start-up Hera Biotech has reported positive interim results for its clinical trial of the MetriDx™ endometriosis diagnostic test.
Data from the first 38 patients who have been enrolled in the study has shown that the test is performing with 92 per cent sensitivity, 95 per cent specificity and an overall accuracy (AUC) of 94 per cent, as compared to the histopathology of excised lesions.
The findings have suggested that the test could have the potential to replace surgical diagnosis and cut the time it takes to diagnose the condition.
“I am thrilled with the interim results of our MetriDx™ endometriosis diagnostic test,” Somer Baburek, co-founder and CEO of Hera Biotech, told Femtech World.
“With an accuracy exceeding 90 per cent, this test has the potential to revolutionise how we diagnose and treat this debilitating condition.
“Currently, surgery is the only definitive way to diagnose endometriosis, but MetriDx™ offers a non-surgical option using a simple endometrial biopsy – which not only reduces patient burden, but also allows for earlier detection and intervention.”
She added: “The ability to stage the disease through this test further empowers physicians to create personalised treatment plans.
“These results are a major step forward, and I’m excited to bring this technology to market soon with the ultimate goal of making a seismic impact in the field of women’s health.”
Hera is focused on a tissue-based approach for diagnosing endometriosis, utilising a pipelle to obtain endometrial cells for analysis. Multiple genes are analysed in numerous cells from each patient, which provides data points for analysis using an AI-generated algorithm.
This single cell assay “complements” the bulk Polymerase Chain Reactions (PCR) assay it acquired from Scailyte earlier this year. Based on these promising results, Hera intends to bring a PCR endometriosis diagnostic test to market in 2025.
Dr Cinzia Donato, Hera Biotech COO, said: “In addition to providing a definitive diagnosis, the results from this interim analysis also shows robust accuracy in staging the disease between early and late stages, a critical determinant in assisting the physician plan treatment options for the patient.
“The ability to stage disease is currently not available until after the patient is in surgery, as there is no reliable correlation between disease symptoms and disease severity.
“Furthermore, the ability to non-surgically diagnose early disease opens up the possibility to screen young patients before the disease has had years to develop and intervene much earlier than currently possible.”
Hera plans to complete the study and announce the final results later this year. The company is currently raising a Series A round of finance.
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