Castle Biosciences announced data from 2 clinical validation studies of its DecisionDx-EC multi-biomarker test at Digestive Disease Week in Chicago, IL. The DecisionDx-EC test analyzes 3 protein biomarkers: NFkB, Gli1, and SHH. Tumors are classified as either responsive to or resistant to CTRT. Clinical data showed the test accurately predicted response to pre-surgical chemoradiation therapy (CTRT) in patients with esophageal adenocarcinoma (EC). Data on predicting extreme resistance to chemoradiation in the treatment of rectal cancer was also presented.
The first validation study was performed at a single center evaluating 167 patient cases, all of whom underwent a chemoradiation regimen involving 5-FU plus platinum/taxanes. The test demonstrated a 97% specificity, 82% positive (PPV), and 94% negative (NPV) predictive values.
The second validation study was performed at multiple centers evaluating 65 patient cases, of whom 68% underwent a 5-FU regimen. The test demonstrated a 95% specificity with 83% PPV and 77% NPV.
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