Achieving performance equivalent to invasive gold-standard methods, HerAnova underscores its leadership in transforming reproductive health diagnostics.

BOSTON, MA, UNITED STATES, October 28, 2025 /EINPresswire.com/ -- HerAnova Lifesciences, leader in non-invasive diagnostic innovation for women’s health, today announced the presentation of updated validation data for its blood-based molecular diagnostic, HerResolve™, at the 2025 American Society for Reproductive Medicine (ASRM) Scientific Congress & Expo in San Antonio, Texas.

At ASRM 2025, HerAnova presented findings confirming the consistent accuracy and reproducibility of HerResolve™ for the non-invasive confirmation of endometriosis. The scientific poster, titled “Laboratory Validation of a Blood-Based miRNA Molecular Diagnostic Using Histology as Comparator for Detection of Endometriosis,” was presented by Dr. Farideh Bischoff, Chief Medical Officer and Head of Diagnostics at HerAnova, as part of the Technology & Innovation: Reproductive Medicine session.

“These findings reinforce the power of molecular diagnostics to transform how we confirm the presence of and manage endometriosis,” said Dr. Farideh Bischoff, Chief Medical Officer and Head of Diagnostics at HerAnova. “HerResolve delivers clinically meaningful insights from a simple blood draw, bringing us closer to eliminating the diagnostic delays that have defined this disease for decades. It’s a major step forward for women, clinicians, and fertility specialists alike.”

Scientific and Clinical Highlights
The prospective validation study enrolled women presenting with symptoms suspicious of endometriosis, who underwent laparoscopic procedure and biopsy. Using qPCR and bioinformatics powered by machine-learning analysis, HerResolve™ quantified the expression of a defined biomarker panel correlated with molecular pathways of endometriosis.

All blood samples were matched with corresponding histology reports, establishing a robust correlation between blood-based molecular data and tissue findings. The study confirmed the test’s strong equivalency to the current gold standard—diagnostic laparoscopy with histology confirmation.

Across ongoing prospective studies of patient samples with matched histology, HerResolve™ continues to demonstrate ≥90% specificity, ≥83% sensitivity, and ≥87% overall accuracy, underscoring its clinical robustness and reproducibility compared to surgical diagnostic methods.

Continuing Momentum Through 2025
The ASRM presentation builds on HerAnova’s active global scientific engagement throughout 2025, including recent presentations at ESHRE, SEUD, WCE, and ACOG, where HerResolve™ consistently demonstrated diagnostic equivalence to surgical gold standards.

HerAnova continues to advance HerResolve™ as a CLIA-validated laboratory-developed test (LDT), with FDA 510(k) submission planned. Commercial introduction in select U.S. reproductive-medicine and IVF centers is anticipated before year-end.

About HerAnova Lifesciences
HerAnova Lifesciences Inc. is a biotechnology company committed to delivering non-invasive diagnostics and treatments designed to meet critical needs in endometriosis and infertility to improve women’s health. By integrating diagnostics, therapeutics, medical devices, and data analytics, HerAnova aims to provide a one-stop solution for unmet needs in obstetrics and gynecology. Founded in March 2022 in Boston by experienced entrepreneurs and former multinational executives, HerAnova operates on a multinational model for its research development and commercialization initiative.

Madelyn De Los Santos
Putnam Insights
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