Hera Biotech Announces Positive Interim Results From Endometriosis Diagnostic Study

Hera’s prospective, blinded, clinical trial evaluating the world’s first molecular, cell-based test for diagnosing and staging endometriosis without surgery has reached the interim data analysis stage

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.

About Hera Biotech

Hera Biotech was formed to apply advances in biotechnology to address unmet needs in women’s healthcare. Its lead product is MetriDx™, a novel, non-surgical test that utilizes gene expression analysis of proprietary biomarkers in endometrial cells for the definitive, early diagnosis and staging of endometriosis.

Hera Biotech was founded in 2020 by Somer Baburek (CEO), Dr. Paul Castella (Executive Chairman), Dr. Bruce Nicholson (CSO), and Dr. Nameer Kirma (Chair of Advisory Board). A bi-product of combined fields of expertise, Hera Biotech is changing the women’s health landscape with its potentially life-changing test for early diagnosis and staging of endometriosis.

For more information, please visit herabiotech.com. Find our link to the media kit here: https://drive.google.com/drive/folders/1LtROaOB-q7cr3mSzVD1uz92XRiavfxL9?usp=sharing

About Endometriosis

Endometriosis can be an extremely painful disorder in which tissue that normally lines the uterus migrates and grows on other organs outside of the uterus. It affects roughly 10-20% of women worldwide and contributes to a large majority of female infertility cases. There is no rapid test for endometriosis, a highly prevalent and debilitating disease, and the current standard of diagnosis is an expensive surgical procedure with histopathology of the excised lesions.

Hera Co-Founders, and co-inventors of the technology, Drs. Bruce Nicholson and Nameer Kirma have been working for many years at the University of Texas Health Science Center San Antonio on the microfluidic, single cell gene analysis technology behind MetriDx™. The University of Texas Health Science Center San Antonio is also one of the centers conducting the multi-center clinical trial. Hera will offer MetriDx™ to both OB/GYN practices and the fertility solutions market to enable the detection and diagnosis of endometriosis without surgery. Furthermore, Hera believes MetriDX™ will help drive the development of new therapeutics for endometriosis, which is currently stymied in the clinic by need for surgical diagnosis and monitoring. Changing the diagnostic landscape for those suffering from this extremely painful condition is potentially life changing. MetriDx™ is a non-surgical solution for diagnosis that Hera hopes to provide endo patients worldwide and help profoundly reshape women’s healthcare options.

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