TestUrGut: In Vitro Diagnostic Test for Intestinal Dysbiosis

qPCR Technology · Non-invasive Sample Collection · 15 Microbial Biomarkers · CE-IVD Certified

Ideation

Product Definition

Product Optimitzation

Product Validation

Regulatory

Testing Service

Product Launch

Product Maintenance

Definition of the microbial marker panel

Selection of 15 biomarkers and optimization of their detection using qPCR.

Optimization in
fecal samples

9 patients with IBS and IBD

24 healthy subjects

Post‑commercialization validation

154 subjects with intestinal discomfort who undergo a TestUrGut

IBS, Irritable Bowel Syndrome; IBD, Inflammatory Bowel Disease.

TestUrGut is an in vitro diagnostic test based on qPCR that enables the diagnosis of intestinal dysbiosis through the detection, in stool samples, of 15 specific microbial markers representative of different functional groups of the gut microbiota.

A growing need in digestive health

Digestive diseases represent a major healthcare and social burden. In Europe, approximately 332 million prevalent cases are recorded, with a significant impact on quality of life, healthcare systems and workplace productivity.

The results of a multicentre study on digestive health in the workplace promoted by the Spanish Association of Specialists in Occupational Medicine (AEEMT) also show an association between greater digestive symptomatology and:

  • Poorer perceived quality of life.
  • A greater presence of pain or discomfort.
  • Greater emotional impact.
  • Increased absenteeism and presenteeism.
  • Lower productivity during the working day.

These data reinforce the need for tools capable of objectively assessing the status of the gut microbiota and detecting potential alterations.

The gut microbiota as a source of biomarkers

The gut microbiota is composed of a complex community of microorganisms involved in essential functions such as digestion, metabolism, regulation of the immune system and communication through the gut-brain axis.

Alterations in its balance and composition, known as dysbiosis, have been associated with different digestive symptoms and disorders. The analysis of representative microorganisms provides information on the status of this ecosystem and supports the assessment of intestinal health.

Based on this knowledge, GoodGut developed TestUrGut as an objective, non-invasive diagnostic tool compatible with the routine workflows of a molecular diagnostics laboratory.

How does TestUrGut work?

TestUrGut uses qPCR to analyse a panel of 15 microbial markers selected for their representativeness and their relationship with functions relevant to intestinal balance. From a stool sample, the analysis enables:

  • Detection and quantification of specific microbial markers.
  • Assessment of different functional groups of the microbiota.
  • Identification of alterations compatible with intestinal dysbiosis.
  • Generation of a structured report to support assessment by the healthcare professional.

The test is intended for individuals over 18 years of age, with or without specific digestive symptoms, when the healthcare professional considers it relevant to assess the status of their gut microbiota.

From scientific development to application in a real-world setting

Definition of the panel and reference values

The initial development phase enabled the definition of a panel of 15 microbial markers and optimisation of their detection by qPCR in stool samples.

Initially, 24 samples from healthy subjects were analysed to establish reference values indicative of intestinal health. Subsequently, the panel was evaluated in nine patients with inflammatory bowel disease or irritable bowel syndrome recruited at Hospital Universitari de Girona Dr. Josep Trueta.

Post-marketing validation

TestUrGut was subsequently evaluated in a study involving 154 adult patients treated for digestive discomfort.

The study analysed the relationship between microbial markers, clinical characteristics and digestive symptoms. The results showed significant associations between specific microbial profiles and factors such as bowel habit, body mass index and sex. The dysbiosis index was also evaluated to differentiate transient and pathological alterations.

The results were published in 2025 in Frontiers in Microbiomes.

Implementation in the corporate setting

TestUrGut was integrated into a multicentre study promoted by AEEMT and pending publication. The study evaluated the implementation of a Digestive Health Promotion Plan based on gut microbiota analysis in a real-world workplace setting.

The results enabled the identification of microbiota alterations both in participants with a reported digestive disorder and in individuals without a previous diagnosis, demonstrating the potential of TestUrGut to provide relevant information for early detection strategies and preventive guidance.

A technology ready to expand its impact

TestUrGut brings together the main elements required to continue its development and facilitate its integration into new settings:

  • qPCR-based molecular technology.
  • Defined panel of 15 microbial markers.
  • Non-invasive procedure using a stool sample.
  • CE-IVD marking.
  • Published clinical evidence.
  • Experience of application in clinical practice and in the corporate setting.
  • Capacity for integration into diagnostic services and structured digestive health programmes.

Are you a healthcare or laboratory professional?

You are accessing the website goodgut.eu, aimed at disseminating technical information on the diagnosis of digestive diseases.

The information contained on this page is intended exclusively for healthcare and/or laboratory professionals with the ability to diagnose digestive diseases and/or analyse the microbiota, which a specialized training is required for its correct interpretation. If you are not a qualified healthcare and/or laboratory professional, GoodGut is not responsible for any prejudice you may suffer from decisions based on the content of this page or any of its links. The information provided to goodgut.eu serves to support, not replace, the relationship that exists between a patient/visitor of this website and their physician.