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Clinical Utility

Introducing novel serological markers for inflammatory bowel disease (IBD) which improve sensitivity and specificity to aid in differential diagnosis and provide valuable prognostic information about disease behavior.

As of 2016, the IBDX panel biomarkers: gASCA, ALCA, ACCA, AMCA, Anti-L and Anti-C were analyzed on over 7500 of patient samples in multiple independent clinical studies around the globe.
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Inflammatory Bowel disease diagnosis

Multiple studies have shown when the IBDX biomarkers are combined with pANCA higher sensitivity and sensitivity is obtained. The IBDX achieved 0.81 to 0.846 area under the curve (AUC) for diagnosing IBD vs non IBD 2, 4, 6, 9, 13, 18 including in pediatric population.14

Chron's disease vs Ulcerative Colitis

 
  • Receiver operating characteristic (ROC) curves of the seven anti-glycan markers (Chron’s disease vs ulcerative colitis)
  • Of the 178 CD patients who were sero negative for both gASCA IgG and gASCA IgA, 6.74 % were positive for anti- L and 5.62 % were positive for anti-C.

*adopted from adopted from: Seow et. al. AJG 2009; 104(6): 1426-1434

   

*adopted from Dotan et. al. Gastroentrology 2006, 131:366–378

Multiple studies have shown that the IBDX panel identifies 35% and 56.4% of ASCA negative patients 1, 2, 3, 4, 6, 8, 9, 12, 13, 18 including pediatric population14, 16

 

CD likelihood of complications and surgery

Studies have shown correlation between the number of positive serological markers and Crohn's Disease behavior and abdominal surgery1, 2, 3, 6, 9, 13, 18 including pediatric population 14, 16

Patients positive for two or more IBDX Antibodies:
  • 70% are likely to have complicated disease8
  • 60% are likely to require abdominal surgery8
Patients positive for three or more IBDX Antibodies:
  • 90% are likely to have complicated disease 8<
  • 80% are likely to require abdominal surgery 8

number of positive serological markers

*adopted from Reider et. al. 2010 IBD 16 (2) 263-274

*adopted from Rieder et al., Inflamm Bowel Dis 2010 16 (8), 1367-1375.

Prospective study demonstrated that Chron’s disease patients positive for at least two IBDX antibodies are likely to progress faster10

Ulcerative Colitis post-Op (IPAA)

Studies have shown that the IBDX ACCA, AMCA and Anti-L can predict Ulcerative Colitis patients who went through ilial pouch-anal anastomis (IPAA) surgery and developed pouchitis 5, 7, 17

* adopted from Ferrante et al., JCC 2008 (2), 142-151.