The article entitled “Development and Independent Validation of a Prognostic Assay for Stage II Colon Cancer Using Formalin-Fixed Paraffin-Embedded Tissue” gives details on the development and validation of a prognostic gene signature in stage II colon cancer.
Colon cancer is the third most common cancer in the US with over 101,000 cases diagnosed per year. Current clinical guidelines for patients presenting with stage II colon cancer recommend treatment with surgery alone. This is effective for approximately 80% of patients, however, 20% of the patients will experience recurrence of the disease and for these patients there might be benefit in offering adjuvant chemotherapy. The Almac test will identify those patients that have higher risk of disease recurrence, providing valuable information to the oncologist to support their further treatment decisions.
Most prognostic factors routinely used in the clinic do not exceed a hazard ratio of 1.5. The Almac developed test gives a hazard ratio of 2.53 with a p value of <0.001. The signature has also been shown to be independent of other prognostic factors.
Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic business unit and Professor of Molecular Oncology at Queens University Belfast said: “The stage II ColDx test represents a significant breakthrough in colon cancer management. We believe that this test will change clinical practice and benefit cancer patients.”
The test has been developed and validated exclusively using formalin fixed paraffin embedded (FFPE) tissue using Almac’s own proprietary Colorectal Cancer DSA®.
Professor Patrick Johnston, Dean, School of Medicine, Dentistry and Biomedical Sciences at Queen’s, said: “We are pleased to have been able to play a role in helping Almac to develop this groundbreaking technology, which we hope could save many lives in the future. Both Queen’s and Almac are working tirelessly in advancing cancer research and treatments.”
The signature is currently undergoing a final external validation study and will be available to patients in 2012.