CALGB validate COLDX assay and Publish in Journal of Clinical Oncology

Press/Media: Research


Craigavon, N.I., UK, – Monday 08 August 2016 Almac Group’s Diagnostics business unit today announced the publication of the second validation study of their stage II colon cancer recurrence signature ColDx in the Journal of Clinical Oncology (JCO).

The publication entitled ‘Association Between Results of a Gene Expression Signature Assay and Recurrence-Free Interval in Patients With Stage II Colon Cancer in Cancer and Leukemia Group B 9581 (Alliance)’ demonstrates that the ColDx assay is a significant, independent predictor of recurrence-free interval (RFI) in stage II colon cancer therefore indicating it’s potential utility with the traditional clinical markers of risk to refine patient prognosis.

The study was performed 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 and Queen’s University Belfast.

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 = 2.13; 95% CI, 1.3-3.5; p < 0.01), including micro-satellite instability (MSI), T-stage and number of nodes examined.

Professor Richard Kennedy, MD, PhD, VP and Medical Director, Almac Diagnostics and McClay Professor in Medical Oncology, Queen’s University Belfast commented “These findings confirm our previous independent validation results which were also published in the Journal of Clinical Oncology in 2011 and further substantiates the ColDx assay as an effective prognostic biomarker for stage II colon cancer. The ability to accurately stratify stage II colon cancer patients into low and high risk categories provides invaluable information, ensuring clinicians are better informed when deciding the most appropriate treatment for their patients.”

The ColDx assay has been out-licensed and is currently being marketed by Helomics® Corporation under the name GeneFx® Colon in the United States.


Period08 Aug 2016

Media coverage


Media coverage

  • TitleCALGB validate COLDX assay and Publish in Journal of Clinical Oncology
    PersonsRichard Kennedy, Paul Harkin