Heranova – Lifesciences

news + events

For immediate release

NEWS PROVIDED BY

Madelyn De Los Santos, Putnam Insights LLC

December 03, 2025, 17:00 GMT

HerAnova™ Study Demonstrates Clinical Feasibility of Blood-Based miRNA Testing for Endometriosis

Reinforcing its leadership in non-invasive innovation, HerAnova’s R&D team advances the scientific foundation behind blood-based detection of endometriosis with publication in Nature Women’s Health.

BOSTON, MA, UNITED STATES, December 3, 2025HerAnova Lifesciences, a leader in non-invasive diagnostic innovation for endometriosis and infertility in women’s health, announced the publication of its first peer-reviewed research study in Nature Women’s Health. The paper provides early proof-of-concept evidence that circulating microRNAs (miRNAs) analyzed from a simple blood draw can aid in the diagnosis of endometriosis non-invasively.

The study conducted by HerAnova’s R&D team highlights the strong scientific potential of miRNA-based diagnostics and demonstrates key technological advances that support HerAnova’s broader diagnostic research program.

“We are proud to have our early scientific work recognized in a Nature journal,” said Dr. Farideh Bischoff, Chief Medical Officer and Head of Diagnostics at HerAnova. “This publication reinforces the feasibility of using miRNA biology and computational modeling to build accessible, clinically meaningful diagnostics in women’s health. It reflects the scientific acumen and dedication of our research team and the potential of this approach to improve the diagnostic journey for women living with endometriosis.”

Study Highlights

The newly published research demonstrates important technical achievements in the discovery and modeling of miRNA biomarkers:

  • The study showed that blood-based miRNA signatures can distinguish endometriosis cases from controls, supporting the viability of miRNA as an analyte for early detection.
  • Machine learning analysis of discovery-phase sequencing data achieved AUC values above 90 percent, indicating high accuracy.
  • The research demonstrated HerAnova’s ability to convert next-generation sequencing findings into more cost-effective and technically accessible PCR-based molecular testing, addressing real-world challenges such as primer design, endometriosis-specific reference endogenous control identification, and algorithm development.
  • The publication reinforces HerAnova’s expertise in molecular biology, diagnostics development, and computational bioinformatics.

About the Study

The proof-of-concept study evaluated circulating miRNAs measured from blood samples using next-generation sequencing followed by computational modeling. While the study represents early-stage research, the findings provide critical scientific feasibility for blood-based diagnostics.

The biomarker models studied in this discovery publication does not represent the final panel or algorithm used in HerAnova’s HerResolveTM laboratory developed test. HerResolve’s U.S. clinical validation, which incorporates a multi-omic biomarker panel, is being prepared for separate peer-reviewed submission in the near future.

Next Steps in HerAnova’s Diagnostic Program

HerAnova continues to advance HerResolve, its blood test to detect endometriosis, as a CLIA-validated laboratory-developed test, with ongoing clinical validation initiatives and future FDA submission planned. The larger U.S.-based validation study will be published separately and will reflect the complete performance characteristics of the clinical assay.

Today’s publication represents an early scientific milestone and supports the company’s continued progress toward delivering the first clinically validated blood-based diagnostic for endometriosis.

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 initiatives.

For more information, visit www.HerAnova.com or contact clinicalaffairs@heranova.com.

Madelyn De Los Santos
Putnam Insights
email us here

Visit HerAnova on social media:
LinkedIn
Instagram
Facebook
X