Almac Publish Second Validation of Stage II Colon Cancer Recurrence Assay in the Journal of Clinical Oncology
08 August 2016
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 Assay 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.
About Almac Diagnostics
Almac Diagnostics is one of five business units operating under the ownership of the Almac Group. The global personalised medicine company is focused on the discovery, development and commercialisation of diagnostic tests including companion diagnostics. In addition, Almac Diagnostics has a pipeline of proprietary oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,000 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).
About Helomics® Corporation
Helomics® is a comprehensive personalized healthcare company, bringing the next generation of diagnostics to the oncology field. Helomics is dedicated to improving patient outcomes by providing a comprehensive personalized tumor profile utilizing a proprietary set of laboratory platforms that leverage both live and fixed cellular analysis to allow physicians to personally characterize malignant tumors. Helomics’ novel molecular and cellular markers and bioinformatics services are designed to support treatment decisions by providing vital information based on the specific biological processes of each individual’s cancer.
Helomics is headquartered in Pittsburgh, Pennsylvania where the company maintains two CLIA-certified laboratories. For more information please visit: www.helomics.com.
About GeneFx® Colon
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 5 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.