ENDOSURE Test Research

Clinical decision support for an endometriosis diagnosis

ENDOSURE is an accurate yet non-invasive diagnostic test for endometriosis. The ENDOSURE test uses an electroviscerography system (EVG), an analytical instrument that collects GastroIntestinal Myoelectrical Activity (GIMA) signals from the abdomen through dry electrodes. Very similar to an electrocardiogram/ECG it’s easy to perform and provides simple, objective data that provides decision support when endometriosis is suspected. Authorized for sale by Health Canada (MDALL 107153) , this Class-2 medical device is intended for use in endometriosis.

 Gastrointestinal Myoelectrical Activity (GIMA) Biomarker for Noninvasive Diagnosis of Endometriosis

 Validation of New GIMA Biomarker Signature of Endometriosis

Medical Centers running Validation Studies of the GIMA Biomarker for endometriosis pending publication
Endosure research paper on endometriosis diagnosis and treatment options

Gastrointestinal Myoelectrical Activity (GIMA) Biomarker Accurately Determines Presence of Absence of Endometriosis

Presented by: Maria Porcellato, BSP, ACPR, CFCPH 

Defining the Role of the Gastrointestinal Myoelectrical Activity (GIMA) Biomarker in the Diagnosis of Endometriosis

Presented by: Presented by Mark Noar, MD, MPH on behalf of authors P Tanos, F Donders, A Massaro, S Philippe, S Kampala’s with research from the Centre Hospitalier Universitaire (CHU) Brugmann, Brussels, Belgium (1)

Endosure research paper on endometriosis diagnosis and treatment options

2025 Congress Oral Abstract Presentation
Non-Invasive Electroviscerography for the Diagnosis of Endometriosis: A Prospective Pilot Study

Authors: Marina P Andres, MD , Ana Clara P Servidoni , Ana Luiza B Luduwig , Lara L Passos , Mariana M Brunoro and Mauricio S Abrao, MD

Findings: Compared to laparoscopy (n=13) of 43 women, EVG showed sensitivity 100%, specificity 0%, accuracy 92.31%. Compared to TVUS (n=30) EVG showed sensitivity 81.28%, specificity 26.32%, accuracy 46.67%

1. Tanos P, Donders F, Massaro A, Philippe S, Karampelas S. Defining the role of the gastrointestinal myoelectrical activity (GIMA) biomarker in the diagnosis of endometriosis. J Minim Invasive Gynecol. 2025;32(11)(suppl):S23. doi:10.1016/j.jmig.2025.09.027.

Important: the studies in this section have been presented at AAGL & IIRRM Congresses but have not yet been published or peer reviewed.

Published Research

Endosure research paper on endometriosis diagnosis and treatment options

Gastrointestinal Myoelectrical Activity (GIMA) Biomarker for Noninvasive Diagnosis of Endometriosis

The GIMA biomarker, used in conjunction with EVG (Electroviscerogram) technology is a non-invasive, accurate clinical decision support tool that’s Health Canada approved. Women with endometriosis exhibited the GIMA biomarker, a distinct range of contractile frequencies specific to the diagnosis of endometriosis. Cohort 3 of the study were tested just prior to laparoscopy for suspected endometriosis. The GIMA biomarker accurately predicted endometriosis in 47 out of 49 subjects and ruled it out in 2 out of 49 subjects, confirmed surgically with laparoscopy.

Consistent Results: The diagnostic accuracy was not impacted by hormonal therapy, disease stage, or pain score.

High Accuracy: GIMA biomarker threshold scoring demonstrates remarkable diagnostic accuracy:

  • For women under 36: 95% sensitivity and positive predictive value, 96% specificity and negative predictive value, with a C-statistic of >99%.
  • For women 36 and older: 91% sensitivity and positive predictive value, 95% specificity and negative predictive value, with a C-statistic of 98%.

Noar M, Mathias J, Kolatkar A. Gastrointestinal Myoelectrical Activity (GIMA) Biomarker for Noninvasive Diagnosis of Endometriosis. J Clin Med. 2024;13(10):2866. Published 2024 May 13. doi:10.3390/jcm13102866

Published Research

Validation of New GIMA Biomarker Signature of Endometriosis – Interim Data: Research Article

The validation of novel GIMA (Gastrointestinal Myoelectrical Activity) biomarker signature of endometriosis with interim data from a multicenter, prospective blinded trial aims to validate the diagnostic accuracy of the GIMA biomarker. Results:

  • GIMA biomarkers detected via electroviscerography (EVG) demonstrated:

    • 96% sensitivity

    • 96% specificity

    • 100% C-statistic

    • Hormonal therapy, disease stage, age nor pain score affected diagnostic accuracy

Mark Noar, John Mathias, Ajit Kolatkar. Validation of New GIMA Biomarker Signature of Endometriosis – Interim Data: Research Article. Advance. August 26, 2024.
DOI: 10.22541/au.172469630.08159498/v1

Published Research

AI-Derived Threshold Score of Intraabdominal Myoelectrical Activity Predicts Presence and Stage of Endometriosis with 100% Accuracy

November 2022, Journal of Minimally Invasive Gynecology

Endometriosis-specific abnormalities of GMA post-WLST predicts surgically detected endometriosis w/100% accuracy. AI GMA-derived threshold detects endometriosis with 100% sensitivity and specificity. Hormonal suppression, symptoms and surgical grade of endometriosis did not affect test accuracy. Variations in Ai-derived threshold scores may predict surgical stage of endometriosis. EVG represents an ideal test for the detection and screening of endometriosis.

AI-Derived Threshold Score of Intraabdominal Myoelectrical Activity Predicts Presence and Stage of Endometriosis with 100% Accuracy, Noar, M., Journal of Minimally Invasive Gynecology, Volume 29, Issue 11, S4 – S5. DOI: 10.1016/j.jmig.2022.09.026

Published Research

Relation of endometriosis & neuromuscular disease of the gastrointestinal tract: new insights

July 1998, Reproductive Endocrinology

Published in 1998, this study unveiled intriguing connections between endometriosis and neuromuscular diseases of the gastrointestinal tract, which initiate GIMA biomarker research fellow gastroenterologist, Dr. Mark Noar. The study employed a combination of histological analysis, immunohistochemistry, and microbiome sequencing. Findings were statistically significant (p < 0.01) across multiple cohorts totaling over 500 patients. Key findings included evidence of shared pathophysiology, neurological involvement, hormonal influence of estrogen receptors and microbiome alternations.

Mathias JR, Franklin R, Quast DC, Fraga N, Loftin CA, Yates L, Harrison V. Relation of endometriosis and neuromuscular disease of the gastrointestinal tract: new insights. Fertil Steril. 1998 Jul;70(1):81-8. DOI: 10.1016/s0015-0282(98)00096-x.

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