Almac’s Diagnostics business unit has announced the presentation of an external validation of their ColDx signature for stage II colon cancer recurrence. Following publication of the initial validation study in the Journal of Clinical Oncology (JCO) in November 2011, Almac subsequently out-licensed the test to Precision Therapeutics, Inc. for further independent validation and commercialization in the USA.
The study performed by Precision Therapeutics in conjunction with the Alliance for Clinical Trials in Oncology (Alliance) comprised of investigators from renowned institutions such as Duke University, Dana-Farber Cancer Institute, University of Chicago, Brigham and Women's Hospital, among others, demonstrates that the ColDx assay is a significant, independent predictor of recurrence-free interval (RFI) in stage II colon cancer. Findings were presented at the 2014 Gastrointestinal Cancers Symposium (ASCO-GI) held January 16-18th, in San Francisco, California.
This large, independent clinical validation study utilized data and samples from 393 stage II colon cancer patients enrolled in the phase III CALGB (Alliance) 9581 clinical trial to assess the ability of the prognostic, 634-probe gene expression signature (ColDx) to improve upon current methods of differentiating patients as higher versus lower risk of recurrence within five years post-surgery.
The signature remained significant after adjustment for conventional prognostic risk factors (hazard ratio = 2.1; 95% CI, 1.3-3.4; p < 0.01), including micro-satellite instability (MSI), T-stage and number of nodes examined. These findings confirm the previous independent validation results published in the Journal of Clinical Oncology in 2011 (Kennedy, et al.). The ColDx assay will be marketed by Precision Therapeutics, Inc. under the name GeneFx® Colon in the United States.
“We are delighted that the ColDx assay has, once again, been validated as a prognostic biomarker for early stage colon cancer” says Richard Kennedy, MD, PhD, McClay Professor in Medical Oncology, Queens University Belfast and VP and Medical Director, Almac Diagnostics. “We believe this assay has the potential to help clinicians personalize the treatment of this disease and look forward to its full commercial launch this year by Precision Therapeutics.”