Cancers (Basel). 2019 Mar 25;11(3). pii: E423. doi: 10.3390/cancers11030423.
A Simple and Highly Specific MassARRAY-Based Stool DNA Assay to Prioritize Follow-up Decisions in Fecal Immunochemical Test-Positive Individuals.
Chang PY1,2, Chen CC3, Chiang JM4, Chang SC5,6, Wang MC7,8, Chen JS9, Tsai WS10, You JF11, Lu JJ12,13.
Abstract
BACKGROUND:
Seventy-five percent of fecal immunochemical test (FIT)-positive individuals are false positives and undergo unnecessary colonoscopies. Here, we established a stool DNA (sDNA) test that uses the Single Allele Base Extension Reaction (SABER) MassARRAY platform to improve the accuracy of FIT-based CRC detection.
METHODS:
Twenty-one variants in five CRC-associated genes were selected for the sDNA panel. Cell line DNA and matched mutation-confirmed tissue and stool samples from 34 patients were used for accuracy assessment (cohort 1). The clinical performance of the sDNA assay was further evaluated in 101 independent FIT-positive stool samples (cohort 2).
RESULTS:
In cohort 1, we obtained a 62% mutation concordance rate in paired tissue and stool samples of the CRC group, regardless of the FIT status. In cohort 2, 100% specificity in normal controls with positive FIT results was observed. By weighting the FIT value and the presence of a given variant type in stool and then summing the two scores, we found that a one-increment increase in the score was associated with a 4.538-fold risk (95% CI = 2.121⁻9.309) for malignancy in the FIT-positive setting.
CONCLUSIONS:
Our highly specific sDNA assay can help prioritize the most at-risk FIT-positive persons to receive prompt colonoscopic confirmation of CRC.
KEYWORDS:
MassARRAY; colorectal cancer; risk-stratifying algorithm; stool DNA
- PMID:
- 30934598
- DOI:
- 10.3390/cancers11030423
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