The importance of biomarkers in the diagnosis and treatment of IBD

Did you know that your body possesses biological characteristics that can be indicators of disease? That’s right, inside your own body are biomarkers – molecules in the body like proteins, lipids, and nucleic acids (DNA, RNA) that may be measured by laboratory tests to assist in diagnosis and management of disease. Biomarkers are used in IBD and  many other disease states, like cancer, diabetes, and cardiovascular and neurodegenerative diseases.

There are two commonly used biomarkers in inflammatory bowel disease (IBD) that allow physicians to, non-invasively, monitor the status of a patient’s disease. These include:
 

• C-reactive protein (CRP), a protein found in your blood that is used as a marker of inflammation
• Fecal calprotectin (FCP), a protein measured using a stool test that can indicate if there’s inflammation in the body

While these are used often in the clinical setting, there are some downsides to them. Both CRP and FCP can’t say if the inflammation in the body is linked to IBD or caused by  other inflammatory conditions. FCP isn’t always covered by insurance and comes with the barrier of patients having to give stool samples.

In 2018 and 2019  the Foundation convened a Biomarker Summit, bringing together stakeholders from academia, industry, nonprofit organizations, patient advocates, and regulatory agencies to identify critical unmet needs in the IBD biomarker space. Most importantly, we began the conversation of how we can all work together to break down barriers and make progress faster. There’s been a lot of work done since that meeting, which Dr. Andres Hurtado-Lorenzo, the Foundation’s Vice President of Translational Research and IBD Ventures, discusses in a recent episode of the About IBD podcast.

In the interview, Dr. Hurtado-Lorenzo discusses the need for more, better, and less invasive biomarkers to help answer critical questions related to the diagnosis, prognosis and monitoring of the course of IBD, as well as the prediction of treatment response. There has been significant progress since our first Biomarker Summit in the research and identification of biomarkers in IBD. Here are updates on some of the work the Foundation is supporting in the biomarker space:

• The Foundation’s Pediatric RISK Stratification Study, the largest, new-onset study completed on pediatric Crohn’s disease patients, worked to identify the genetic, microbiological, and immunological factors in children that can be used as biomarkers of complicated disease course and response to treatment. Researchers developed a RISK prediction model that integrates clinical and genetic data, and we are working to use these and additional new findings to develop a prognostic test to predict disease complications at diagnosis.
• Through IBD Ventures, our venture philanthropy initiative, we are supporting the PRECIOUS Study, a clinical study that is currently underway to validate the prognostic value of PredictImmune’s IBD test, which measures mRNA biomarkers in blood. This study builds upon the company’s research the UK, where the test is already approved and in use for the prognosis of disease severity in adult IBD patients.
• We are also supporting the work of Glycominds, a company that has developed a blood test that uses five unique protein biomarkers of inflammation and disease activity along with a proprietary algorithm (the ulcerative colitis response index, or UCRI) to monitor intestinal healing in response to treatment with a biologic medication. 
• The Foundation is supporting a study at the University of Texas at Dallas where researchers developed a wristwatch-like wearable device that monitors sweat for biomarkers that could signal flares of IBD. With the proof-of-concept study completed in healthy volunteers, the researchers are now studying the device in IBD patients with various levels of disease activity. 

The work in the biomarkers space is vast and ongoing but one thing is certain—it is a very exciting field, and we hope it will yield some new, non-invasive ways of diagnosing, prognosticating and monitoring disease for patients and help advance precision medicine for IBD. You can read more about the Foundation’s work on biomarkers in this article from Inflammatory Bowel Diseases.