A first-of-its-kind noninvasive blood test is changing the game for endometriosis diagnosis. The HerResolve test, developed by HerAnova Life Sciences, identified 61.5% of endometriosis cases missed by transvaginal ultrasound or MRI. With diagnosis delays averaging 7–10 years, the test could dramatically shorten the path to treatment — and an FDA de novo classification request is expected later this year.
Diagnosing endometriosis has long been a frustrating, years-long ordeal for millions of women — but a new blood test could change that. HerAnova Life Sciences presented clinical validation data for its HerResolve test at the 2026 Endocrine Society annual meeting, showing it can identify endometriosis cases that standard imaging tools like transvaginal ultrasound and MRI miss entirely.
HerResolve is a multiomic test, meaning it analyzes microRNAs, protein biomarkers, and a steroid serum biomarker simultaneously, then runs the data through a machine-learning algorithm alongside patient age and BMI. In validation testing across ethnically diverse patients at multiple clinical sites, the test achieved an AUC of 0.944, with 80% sensitivity and 97.5% specificity. It's currently available as a laboratory-developed test at $499 out-of-pocket, with an FDA de novo classification request planned for later this year.
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Why it matters: Endometriosis currently requires invasive laparoscopic surgery for a definitive diagnosis. A reliable, noninvasive blood test could serve as a triage tool to fast-track patients to treatment — sparing them years of pain and unnecessary procedures.
