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Almac Validates ColDx Assay

Out-licenses test to Precision Therapeutics

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By: Kristin Brooks

Managing Editor, Contract Pharma

Almac’s Diagnostics business unit has validated its ColDx signature for stage II colon cancer recurrence. Almac has out-licensed the test to Precision Therapeutics, Inc. for further independent validation and commercialization in the U.S. The study, performed by Precision Therapeutics in conjunction with the Alliance for Clinical Trials in Oncology, demonstrates that the ColDx assay is a significant, independent predictor of recurrence-free interval (RFI) in stage II colon cancer.
 
The independent clinical validation study utilized data and samples from 393 stage II colon cancer patients enrolled in the Phase III Alliance 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 ColDx assay will be marketed by Precision Therapeutics under the name GeneFx Colon in the U.S.
 
“We are delighted that the ColDx assay has, once again, been validated as a prognostic biomarker for early stage colon cancer” said Richard Kennedy, MD, Ph.D., McClay Professor in Medical Oncology, Queens University Belfast and vice president 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.”

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