Blood tests can finally diagnose endometriosis

For decades, the only way to confirm endometriosis was surgery. Two blood tests reached US clinics in 2026 promising a diagnosis from a single draw. Neither has FDA clearance. Here is what that gap means.

The gist
Kephera Diagnostics launched EndomTest, a 2-biomarker blood test that flags likely endometriosis.
HerAnova Lifesciences launched HerResolve, a 7-marker panel now running at IVF centers, with a published 94.4% accuracy / 97.5% specificity in a 298-woman study.
Both are Laboratory Developed Tests (LDTs), not FDA-cleared diagnostics. Kephera has not filed; HerAnova has said it plans to.
The surgical gold standard (laparoscopy) still confirms a diagnosis. These tests aim to end the wait to get to that point, not replace it outright.

The average wait to get diagnosed with endometriosis is measured in years, not visits. WHO and ACOG both put the disease at roughly 1 in 10 women of reproductive age. Confirming it has meant a laparoscopy: an invasive surgery to directly view and biopsy tissue outside the uterus. A blood draw is now a real alternative for a first read.

Two different companies shipped two different tests. Kephera Diagnostics' EndomTest combines two protein biomarkers with clinical variables into a rule-in tool. HerAnova Lifesciences' HerResolve goes wider: three microRNAs, three proteins, and one steroid hormone biomarker. HerAnova's own multicenter case-control study, run across 298 women, reported 94.4% accuracy and 97.5% specificity. HerResolve is already in use at reproductive medicine and IVF centers including Reproductive Partners Medical Group and CNY Fertility locations.

Neither test has FDA clearance. Both run as Laboratory Developed Tests (LDTs), reviewed under CLIA and CAP lab-certification standards rather than FDA premarket review. HerAnova has said it plans to file for FDA de novo classification; Kephera has not announced a filing. Plenty of legitimate lab tests run as LDTs, so the label alone says little. What it does say is that these tests have cleared a materially lower bar than FDA clearance, and coverage that blurs the two overstates how validated they are.

A positive result narrows things down; it does not replace the surgical diagnosis. Laparoscopy remains the confirmatory standard. What a blood test changes is the front door: instead of years of symptom-tracking before anyone orders invasive surgery, a blood draw can support the case for one sooner, or flag it as worth pursuing at all.

The community reaction says more about the old wait than the new test. On r/endometriosis, a 411-upvote thread on the launch drew replies like "took me over 20 years to get diagnosed" and a comparison against a $4,000 out-of-pocket laparoscopy bill. That reaction is less about a lab assay and more about a decade spent fighting to get one specific piece of evidence taken seriously.

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