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ColDx Stage II Colon Cancer Recurrence Test Published in JCO
Almac’s recent publication is entitled “Development and Independent Validation of a Prognostic Assay for Stage II Colon Cancer Using Formalin-Fixed Paraffin-Embedded Tissue” gives detail on the development and validation of a prognostic gene signature in Stage II colon cancer.
Colorectal Cancer is the third most common cancer in the United States with over 140,000 cases of colorectal cancer per year. Current clinical guidelines for patients presenting with stage II colon cancer recommend treatment with surgery alone. This is effective for around 80% of patients, however 20% of the patients will experience recurrence of the disease and for these patients there may be benefit in offering adjuvant chemotherapy. There is currently no test used in standard clinical practice to identify these high risk patients and this is the aim of the Almac developed signature.
Current prognostic factors which are used such as T-stage and perforation are not sufficient and provide a hazard ratio (HR) of less than 1.5. The Almac developed test gives a hazard ratio of 2.62 with a p-value of <0.001. The signature has also been shown to be independent of other prognostic factors.
The test has been developed and validated exclusively using formalin fixed paraffin embedded (FFPE) tissue using Almac’s own proprietary Colorectal Cancer DSA®. The signature is currently undergoing a final external validation study and will be available to patients in 2012.
To view the paper click here.
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