Dr. Dana Lukin, MD, AGAF, from Weill Cornell Medical College, praised the method for its potential in confirming IBD diagnoses and distinguishing IBD from non-IBD cases. However, he also highlighted the need to determine if cfDNA can differentiate between IBD and other conditions like colorectal cancer or infections that produce similar microbial signatures.
- Shiv Kale, PhD, from Karius Inc., presented the results at the annual Crohn’s & Colitis Congress®. The company’s Karius Test, which is being developed for various infections and febrile neutropenia, also focuses on cfDNA.
- cfDNA has been a useful biomarker in cancer screening, prenatal testing, and organ monitoring post-transplantation. It is based on the release of DNA from human and microbial cells after cell death, which is detectable in plasma.
- The study included 196 patients with Crohn’s disease and 196 with ulcerative colitis, encompassing various disease severities. All patients underwent endoscopic assessment within 30 days of plasma measurements.
- cfDNA successfully distinguished between patients with Crohn’s disease, ulcerative colitis, and asymptomatic individuals with a high sensitivity (99.5%) and specificity (90%).
- A follow-up study involving 1800 samples is planned in collaboration with the Crohn’s and Colitis Foundation to further examine cfDNA’s ability to determine disease severity, location, and subtypes of Crohn’s disease.
- The method’s ability to differentiate between IBD and non-IBD is particularly notable, as current serologic-based assays struggle in this area.
Considerations and Potential Applications:
- The technology could be especially useful for children, those reluctant to undergo invasive testing, or where such testing is logistically challenging.
- Prospective studies are needed to validate this approach and to see if cfDNA can correlate with disease activity over time.