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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.
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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.
For more information call or visit CastleBioSciences.com.
