Clinical development of a blood biomarker using apolipoprotein-A2 isoforms for early detection of pancreatic cancer.

ABSTRACT:

Background

We have previously reported apolipoprotein A2-isoforms (apoA2-is) as candidate plasma biomarkers for early-stage pancreatic cancer. The aim of this study was the clinical development of apoA2-is.

Methods

We established a new enzyme-linked immunosorbent sandwich assay for apoA2-is under the Japanese medical device Quality Management System requirements and performed in vitro diagnostic tests with prespecified end points using 2732 plasma samples. The clinical equivalence and significance of apoA2-is were compared with CA19-9.

Results

The point estimate of the area under the curve to distinguish between pancreatic cancer (n = 106) and healthy controls (n = 106) was higher for apoA2-ATQ/AT [0.879, 95% confidence interval (CI): 0.832-0.925] than for CA19-9 (0.8

SUBMITTER: Kashiro A 

PROVIDER: S-EPMC10904523 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature