November 06, 2026
3 min watch
Key takeaways:
- Fecal elastase is the recommended diagnostic test for exocrine pancreatic insufficiency, but it has limitations.
- A novel blood-based biomarker, apolipoprotein A2 isoform, has shown to be a promising alternative.
NASHVILLE, Tenn. — A novel blood test could work just as effectively as the use of fecal elastase in diagnosing exocrine pancreatic insufficiency, according to a study presented at ACG Annual Scientific Meeting.
“Currently, fecal elastase is the recommended diagnostic test,” Medora D. Rodrigues, MD, MPH, a fellow at The Ohio State University Wexner Medical Center and the study’s lead author, told Healio. “But it has limitations, including low completion rates of approximately 25% to 40% and falsely low results in patients with watery diarrhea.”
Rodrigues and colleagues conducted a pilot study to assess the feasibility of a new blood-based biomarker, apolipoprotein A2 isoform (ApoA2-i), in diagnosing exocrine pancreatic insufficiency (EPI) and reflecting its severity. Those results were then compared with fecal elastase (FE-1).
Study participants had already completed FE-1 testing, and blood was drawn for multiple forms of ApoA2-i (ApoA2-AT, ApoA2-ATQ and ApoA2-i index), as well as trypsin — a pancreatic enzyme — and fat-soluble vitamins. Participants were then classified as having normal exocrine function, mild EPI, moderate EPI or severe EPI based on symptoms, FE-1, clinical history and nutrition parameters.
“Importantly, investigators were blinded to ApoA2 results during adjudication,” Rodrigues said.
Of the 72 patients who consented, 71 provided a ApoA2-i blood sample, which made for a 99% completion rate. The researchers found that 44 of those patients had normal exocrine function, 15 were classified as having mild/moderate EPI and 12 had severe EPI. Of those assessments, the researchers had high confidence in 61 and low confidence in 10.
ApoA2-AT, the ApoA2-i index and trypsin levels differed significantly between patients with and without EPI. ApoA2-AT had an area under the curve of 0.87, compared with 0.88 for trypsin and 0.93 for FE-1. ApoA2-AT, ApoA2-i index and trypsin levels also decreased with worsening pancreatic exocrine function. ApoA2-ATQ levels did not differ significantly between participants with and without EPI.
ApoA2-i showed a strong association with EPI and its severity, though it did not outperform FE-1 and trypsin in terms of AUC.
“Our findings suggest that ApoA2 isoforms, particularly ApoA2-AT, are promising blood-based biomarkers for EPI,” Rodrigues told Healio. “The strong diagnostic discrimination, association with disease severity and high blood cell completion rate are encouraging; however, large studies are needed to validate these findings and establish diagnostic thresholds.
For more information:
Medora D. Rodrigues, MD, MPH, can be reached at gastroenterology@healio.com.
Sources/Disclosures
Source:
Rodrigues MD, et al. Apolipoprotein A2 isoforms: A novel blood-based biomarker for exocrine pancreatic insufficiency. Presented at: ACG Annual Scientific Meeting; Oct. 12-14; 2026; Nashville, Tenn. (hybrid meeting).
Disclosures:
Rodrigues reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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