Results of independent clinical validation study of Almac-developed ColDx assay presented at ASCO-GI

Almac’s Diagnostics business unit recently 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 for further independent validation and commercialisation in the US.

The study performed by Precision Therapeutics in conjunction with the Alliance for Clinical Trials in Oncology (Alliance) comprised 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 16-18, in San Francisco, California.

The Alliance for Clinical Trials in Oncology is a national clinical trials network sponsored by the National Cancer Institute that consists of a network of nearly 10,000 cancer specialists at hospitals, medical centres, and community sites across the country and Canada. The Alliance is dedicated to developing and conducting clinical trials with promising new cancer therapies, and utilises the best science to develop optimal treatment and prevention strategies for cancer, as well as researching methods to alleviate side effects of cancer and cancer treatments.

This large, independent clinical validation study utilised 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 per cent 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 under the name GeneFx Colon in the US.

GeneFx Colon is a microarray-based gene signature developed for FFPE tissue from stage II colon cancer patients. GeneFx Colon is performed on a small amount of tissue, removed during surgery and identifies patients at higher risk of recurrence within five years following initial surgery. GeneFx Colon is expected to provide better-informed and more personalised treatment decisions for the physicians and patients facing this disease.

EP News Bureau-Mumbai