SAN ANTONIO– Hera Biotech is pleased to report the interim results for its proof-of-concept multi-center clinical trial of the MetriDx™ endometriosis diagnostic test. Per protocol data from the first 38 patients who have been enrolled in the 60 patient study shows that the diagnostic test is performing with 92% sensitivity, 95% specificity and an overall accuracy (AUC) of 94%, as compared to the histopathology 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 is focused on a tissue based approach for diagnosing endometriosis, utilizing a pipelle to non-surgically obtain endometrial cells for analysis. Multiple genes are analyzed in numerous cells from each patient, which provides thousands of data points for analysis using a proprietary 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 rapid bulk PCR endometriosis diagnostic test to market in 2025.
“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.”
Hera plans to complete the study and announce final results mid-year. To commercialize the tests under development, the company is currently raising a Series A round of finance.
