ORLANDO — A novel multi-biomarker serum test accurately evaluated mucosal healing across different subtypes of Crohn’s disease based on disease location, according to new research presented at the World Congress of Gastroenterology at ACG 2017.
“We have now a peripheral blood test ... that can be used as a noninvasive surrogate marker for mucosal endoscopic disease severity in Crohn’s disease,” Geert D'Haens, MD, PhD, professor of gastroenterology at the Academic Medical Center in Amsterdam, said during his presentation.
“There is good overall accuracy with all disease locations,” and across different treatments, he added.
The test, called the Prometheus Monitr Crohn’s Disease (Prometheus Labs), provides a single score called the Mucosal Healing Index (MHI) based on 13 biomarkers representing multiple mucosal injury and repair pathways, including CEACAM1, VCAM1, C-reactive protein, Ang1, Ang2, interleukin-7, TGF-alpha, SAA1, MMP1, MMP2, MMP3, MMP9 and EMMPRIN. The test was previously developed and validated using 748 serum specimens with matching colonoscopy scores, and indicates mucosal healing on a 100-point scale.
To validate the MHI based on Crohn’s disease location, D’Haens and colleagues assessed 412 longitudinal specimens collected from 118 patients with Crohn’s disease enrolled in the TAILORIX trial, at or near the time of endoscopy. A central reader evaluated endoscopy scores.
Overall, 22.9% of patients had ileal Crohn’s disease, 60.2% had ileocolonic Crohn’s, and 16.9% had colonic Crohn’s. The test performed 90% overall accuracy, and with 95%, 90% and 87% accuracy for each of these respective subtypes.
Additionally, it performed with an overall sensitivity of 82%, specificity of 94%, a positive predictive value of 87% and a negative predictive value of 92%,
“This test seems to be very useful for clinical practice [for monitoring] the intestinal mucosal disease in patients with Crohn’s disease,” D’Haens concluded. – by Adam Leitenberger
D’Haens G, et al. Abstract 74. Presented at: World Congress of Gastroenterology at American College of Gastroenterology Annual Scientific Meeting; Oct. 13-18, 2017; Orlando, FL.
Disclosures: D’Haens reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.
Editor's Note: This article was updated on October 26 to reflect the product's brand name.