Blood Test Enables Non-Invasive Endometriosis Detection

Endometriosis is a chronic, complex, yet relatively common gynecological disorder, reportedly affecting 1 in 10 adult and adolescent women. Endometriosis causes tissue similar to the lining of the uterus to grow outside the uterus, which can cause severe pelvic pain and make it harder to become pregnant. The current gold standard for confirming endometriosis diagnosis is laparoscopic surgery, which can often result in missed or late diagnosis. Now, a first-of-its-kind blood test can confirm endometriosis in symptomatic women.

HerAnova Lifesciences (Burlington, MA, USA) has developed and commercialized HerResolve, a groundbreaking diagnostic for endometriosis that confirms endometriosis with a simple blood test. Using quantitative PCR (qPCR) and bioinformatics powered by machine learning, HerResolve measures the expression of a defined biomarker panel correlated with molecular pathways of endometriosis.

Recent clinical validation data presented by the company demonstrate that HerResolve achieved accuracy equivalent to histology-confirmed laparoscopy, the current diagnostic gold standard, in diagnosing endometriosis. The objective of the study was to demonstrate the efficacy of HerResolve in performing noninvasive, blood-based testing to confirm the presence of endometriosis among women considering laparoscopy for symptomatic evaluation. The current gold standard for diagnosis relies on direct visualization of lesions via laparoscopy, an invasive surgical procedure that can delay or limit diagnosis for many patients. Each blood sample in the validation study was paired with a corresponding histology report, confirming a strong correlation between molecular and tissue-based diagnoses.

Across ongoing prospective studies, HerResolve demonstrated ≥90% specificity, ≥83% sensitivity, and ≥87% overall accuracy, underscoring its equivalence to invasive diagnostic methods. 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 remains on track for late 2025.

“Our findings continue to demonstrate that molecular diagnostics can deliver valuable insights through a simple blood draw, aiding in the diagnosis of endometriosis and optimizing surgical planning for women who may have waited years for answers,” said Dr. Farideh Bischoff, Chief Medical Officer and Head of Diagnostics at HerAnova. “Beyond early detection, HerResolve can offer practical value for MIG surgeons by informing surgical planning by helping to anticipate lesion burden, prioritize patients for laparoscopy, and prepare for potentially complex cases that warrant extended visualization and excision.”

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