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M2-PK Test for CRC Showed Superior Sensitivity to iFOBT
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A novel screening kit for colorectal cancer that uses the immunochromatographic fecal tumor M2 pyruvate kinase test demonstrated increased sensitivity for identifying cancer and adenomatous lesions compared with the immunochromatographic fecal occult blood test, according to new study data.
Researchers from Korea attempted to determine the utility of the immunochromatographic M2 pyruvate kinase (iM2-PK) in screening for CRC and premalignant lesions by comparing iM2-PK with the immunochromatographic fecal occult blood test (iFOBT), serum carcinoembryonic antigen (CEA) and fecal tumor M2-PK enzyme-linked immunosorbent assay (ELISA).
From April 2012 to March 2013, researchers evaluated 60 healthy controls (median age, 55 years), 124 patients with colonic adenoma (median age, 63 years) and 139 patients with CRC (median age, 66 years) enrolled at six academic hospitals. All participants had stool samples collected, and they underwent complete colonoscopy and blood sampling.
The researchers found that the iM2-PK had superior sensitivity for CRC compared with iFOBT and CEA (92.8% vs. 47.5% vs. 45.3%; P<.05); iM2-PK also had superior sensitivity for adenomatous lesions compared with iFOBT and CEA (69.4% vs. 12.1% vs. 46.8%; P<.05), but specificity was similar. Negative predictive value for CRC also was superior with iM2-PK compared with iFOBT and CEA (83.3% vs. 40.7% vs. 40.6%; P<.05), and negative predictive value for colorectal adenoma was better with iM2-PK compared with iFOBT (56.8% vs. 31.5%; P<.05). Compared with M2-PK ELISA, iM2-PK also had superior sensitivity for CRC (97.5% vs. 80%; P=.0289). The sensitivity of iM2-PK increased with advanced stages of CRC compared with cancers in the mucosa and submucosa (P<.05), but lymph node metastasis did not influence the sensitivity.
“iM2-PK test proved to have significantly higher sensitivity for CRC and colon adenomatous lesions than that of iFOBT and CEA,” the researchers concluded. “The negative predictive value of iM2-PK was also better than iFOBT. The iM2-PK has strength in its affordable cost, convenience in use and the rapidity for result. iM2-PK may be a reliable and acceptable screening method for CRC.”
Disclosure: The researchers report no relevant financial disclosures.
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