Almac's Diagnostics business unit has opened its CLIA registered laboratory, which will enable the use of novel tests to stratify and enrich prospective clinical trials.
This ability is of key importance as Almac begins to transition the novel biomarkers that it has developed into clinical use, with the resulting potential to inform the drug-development process and to target therapies to responsive patients.
In addition to standard molecular tests, Almac has both internal clinical tests and companion diagnostic tests with Pharma partners in development that will be delivered from the Almac CLIA Laboratory.
Professor Paul Harkin, president and managing director of Almac's Diagnostics business, said: 'We have come to a point where the biomarkers we have discovered and assays that we have developed are being used to stratify patients, enrich clinical trials and impact patient treatment decisions.
'As such, CLIA is a key necessity for the processing of these samples,' he added.
Almac's genomics laboratories have been supporting biomarker discovery projects for eight years and already operate under ISO17025 accreditation and work to the principles of GLP.