Hera Biotech has shared interim findings from its ongoing clinical trial evaluating the MetriDx endometriosis diagnostic test. This trial, aimed at assessing the world’s first molecular, cell-based test for diagnosing and staging endometriosis without surgery, has reached the interim data analysis phase, shedding light on promising outcomes.
Based on protocol data from the initial 38 participants enrolled in the 60-patient study, the MetriDx diagnostic test demonstrated encouraging performance metrics. The test exhibited 92% sensitivity, 95% specificity, and an overall accuracy (AUC) of 94% compared to histopathology results of excised lesions.
“This result suggests that Hera’s molecular diagnostic test has the potential to replace surgical diagnosis and greatly improve the woefully inadequate state of endometriosis diagnosis and treatment that exists today,” said Hera Biotech CEO Somer Baburek.
Hera Biotech’s approach focuses on a tissue-based method for diagnosing endometriosis, utilizing a pipelle to non-surgically obtain endometrial cells for analysis. By analyzing multiple genes in numerous cells from each patient using a proprietary AI-generated algorithm, Hera aims to provide a comprehensive assessment of the disease. The interim analysis also highlights the robust accuracy of the test in staging the disease between early and late stages, facilitating better treatment planning.
“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,” said Hera Biotech COO Dr. Cinzia Donato. “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.”
Endometriosis, affecting approximately 10-20% of women worldwide, presents significant challenges due to its painful symptoms and association with female infertility. The current standard of diagnosis involves an expensive surgical procedure with histopathology of excised lesions. Hera Biotech’s MetriDx offers a promising alternative that could improve the diagnostic landscape for endometriosis.
The company plans to complete the study and announce final results mid-year, with intentions to bring a rapid bulk PCR endometriosis diagnostic test to market in 2025. To support its commercialization efforts, Hera Biotech is currently raising a Series A round of finance.
