New approaches to diagnosing endometriosis are moving toward less invasive testing strategies as researchers and healthcare organizations seek alternatives to surgical confirmation.
Recent guidance from the National Institute for Health and Care Excellence (NICE) highlights two technologies—Endotest and Endosure—that may be used in primary care in England and Wales while additional evidence is collected.
At the same time, researchers at the University of Edinburgh have identified a blood-based hormone signature that could support development of another diagnostic technology, known as DotEndo.
Endometriosis occurs when cells similar to those in the lining of the uterus grow elsewhere in the body. These cells can respond to hormonal signals, contributing to inflammation, pain, and scar tissue formation.
The diagnosis of endometriosis is currently confirmed through laparoscopy, an invasive surgical procedure that can contribute to lengthy delays before patients receive answers.
New technologies target different diagnostic pathways
Endotest and Endosure are among the first noninvasive technologies to receive conditional recommendations from NICE while additional evidence is gathered.
Endotest analyzes a saliva sample for microRNAs, biological markers that may indicate whether endometriosis is present. Evidence reviewed by NICE from three peer-reviewed prospective studies reported sensitivity ranging from 96% to 97.3% and specificity ranging from 94.1% to 100%.
Endosure uses sensor pads placed on the abdomen to measure electrical signals in the gut. The test takes approximately 45 minutes, with results available immediately after testing. Evidence reviewed by NICE from two peer-reviewed prospective studies reported sensitivity ranging from 91% to 96% and specificity ranging from 95% to 96%.
NICE recommended that both technologies could be used in primary care in England and Wales during a three-year evidence-generation period while companies collect additional data. The organization noted that implementation will require healthcare professional training, clinical resources, and evaluation of how the tests fit into existing diagnostic workflows.
Tom Clutton-Brock, chair of NICE’s diagnostics advisory committee, said in a recent BMJ article that “while the evidence base is still developing and most studies have been conducted in secondary or tertiary care settings outside the UK, we believe the potential benefits of earlier diagnosis in primary care justify a conditional recommendation while further evidence is gathered.”
Blood-based hormone biomarkers offer another approach
A third technology, DotEndo, is being investigated as a blood-based diagnostic approach using hormone biomarkers. NICE identified DotEndo as requiring more research before it could be considered for NHS funding.
Researchers at the University of Edinburgh analyzed blood hormone levels from 159 women with confirmed endometriosis and 57 women without the condition. The study focused on androgens, including 11-oxygenated androgens produced by the adrenal glands—a group of hormones that has received less attention in endometriosis research compared with estrogen and progesterone.
The researchers identified a distinct hormone fingerprint among individuals with endometriosis, including higher levels of the androgen 11-ketotestosterone. This hormone signature differentiated between individuals with and without endometriosis and correctly identified more than 95% of patients with the condition in the study population.
“These findings mark a significant breakthrough in our understanding of endometriosis," Douglas Gibson, PhD, from the University of Edinburgh’s Centre for Reproductive Health and senior author of the study, said in a press release. "Traditionally seen as an estrogen-driven disorder, our research challenges this view by showing different androgen levels in the condition. We are optimistic that this new insight will lead to earlier diagnosis and the development of innovative new treatments for those affected by endometriosis.”
The researchers are working with Edinburgh Innovations to identify industry partners interested in developing a diagnostic blood test based on the findings. However, researchers noted that additional studies are needed to validate the androgen biomarker signature in larger and more diverse populations.
Toward biomarker-driven testing
The development of these three technologies reflects a broader effort to improve endometriosis diagnosis through non-surgical testing.
“These tests are a game changer because they give us answers much earlier, without the need for invasive surgery, and that means we can start the right treatment sooner,” Gail Busby, consultant gynecologist at Manchester University NHS Foundation Trust, said in a recent BMJ article.
For clinical laboratories, these emerging approaches highlight the growing role of biomarker discovery, assay validation, and evidence generation in developing diagnostic tools for complex conditions that have historically lacked simple testing options, such as Alzheimer’s disease and colorectal cancer, as well as for prenatal screening.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
