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米国のFDAによる2014/3/28の updateをお知らせします。




FDA Panel Endorses Stool-Based DNA Colon Cancer Test

Key Points:
  • An FDA panel has unanimously determined that Cologuard, a noninvasive, stool-based DNA screening test for colorectal cancer, has demonstrated safety, effectiveness, and a favorable risk-benefit profile.
  • Results of clinical trial show that Cologuard had a significantly higher sensitivity for detecting colorectal cancer compared with fecal immunochemical testing.
  • Cologuard is used to analyze stool samples for the presence of DNA methylation and mutation markers, total DNA, and hemoglobin.

2.3% sensitivity for all 65 malignancies vs 74% for fecal immunochemical testing and 93.3% sensitivity in detecting the stage I–III colorectal cancers, vs 73% for fecal immunochemical testing.

In addition, sensitivity for patients with advanced precancerous lesions was 42% for Cologuard vs 24% for fecal immunochemical testing.

The DNA test detected 69% of patients with polyps with high-grade dysplasia vs 46% for fecal immunochemical testing.

Specificities for Cologuard vs fecal immunochemical testing were 87% vs 95%.